JUNE 2016 page 30 - CAP TODAY

automated immunoassay analyzers

Tabulation does not represent an endorsement by the College of American Pathologists.

30 CAP TODAY | JUNE 2016

JUNE 2016 page 30

Part 1 of 21 Abbott Diagnostics Abbott Diagnostics Abbott Diagnostics100 Abbott Park Rd., CP1-4 100 Abbott Park Rd., CP1-4 100 Abbott Park Rd., CP1-4

See captodayonline.com/productguides for an interactive version of guide

Abbott Park, IL 60064 Abbott Park, IL 60064 Abbott Park, IL 60064224-667-5678 www.abbottdiagnostics.com 224-667-5678 www.abbottdiagnostics.com 224-667-5678 www.abbottdiagnostics.com

Name of instrument/First year sold/Where designed ARCHITECT i1000SR/2008/U.S. ARCHITECT i2000SR/2002, i4000SR/2007/U.S. ARCHITECT ci4100 (2009), ci8200 (2003), ci16200 (2007)/U.S.Country where manufactured/Where reagents manufactured Singapore/U.S., Europe Singapore/U.S., Europe Singapore (IA), Japan (chemistry)/U.S., EuropeNumber of units in clinical use in U.S./Outside U.S. — — —Operational type/Model type/Sample handling system continuous random access/floor standing/robotic sample

handler allows batch, random access, continuous access, and reagent loading and unloading

batch, random access, continuous random access/ floor standing/track and LAS

batch, random access, continuous random access/floor standing/robotic sample handler uses multidimensional sample handling

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 59 × 30/12.3 48 × 61 × 49/20.7 (i2000SR) 48 × 127 × 49/43.2

Tests available on instrument in U.S. — — —Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — —Tests in development — — —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system — — —Number of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence/magnetic particle Chemiflex (enhanced chemiluminescence) with 5 flexible protocols/magnetic microparticle

photometric, potentiometric, and Chemiflex (enhanced chemiluminescence)/—

Number of different measured assays onboard simultaneously 25 25 80–93, based on analyzerNumber of different assays programmed, calibrated at once 61 62 149 assays availableNumber of user-definable (open) channels none none 220 (on chemistry modules only)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100 25/100 tests and 500 tests per kit 93/61–1,700

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days (vitamin D)/30 days tracked in hours/yes 14 days (vitamin D)/30 days tracked in hours/yes CC: 5 days/28 days/yes; IA: 14 days (vitamin D)/30 days tracked in hours/yes

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/assay number, reagent serial number, lot number, tests

per kit, expiration onboard stability time, othersyes/assay No., reagent serial No., lot No., tests per kit, exp. date, onboard stability time, master calibration curve

yes/assay name, reagent number, lot number, tests per kit, expiration date, others

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/<0.1 ppm no/<0.1 ppm yes (chemistry)/<0.1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 180/65/25 300/135/12,500 300/367/>75,000System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes (chemistry)/liquidUses disposable cuvettes/Maximum number stored yes/360 yes/1,200 disposable and semipermanent/see individual standalone

modulesUses washable cuvettes/Replacement frequency no/— no/— yes/as needed, minimum 1-year guarantee

Minimum specimen volume required varies based on assay varies based on assay varies based on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 10 µL/50 µL 2 µL (chemistry), 10 µL (IA)/50 µL

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/yesRequires dedicated water system/Water consumption no/— no/— yes/25 L per hour (ci8200); 52 L per hour (ci16200);

15 L per hour (ci4100)Noise generated 58 decibels during normal operation, 62 decibels maximum 48–70 decibels 48 –70 decibels

Has dedicated pediatric sample cup/Dead volume no/— no/— no/—

Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-,10-mL tubes and sample cups/no yes/5-, 7-, 10-mL tubes and sample cups/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yes

Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yes

Clot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yes

Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2–6, assay dependent 2–6, assay dependent 2–6, assay dependentCalibrants can be stored onboard/Average calibration frequency no/calibration required with new lot no/calibration required with new lot IA: no/calibration with new lot; CC: no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte) yes/yes (up to 4 curves per analyte)

How often QC required every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedure every 24 hours or per lab-specific procedureOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yes

Automatic shutdown/Startup is programmable/Startup time no/no/6.5 minutes —/no/10 minutes —/no/10 minutes

Stat time to completion of βhCG test 18 minutes 18 minutes 18 minutesTime delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 33 samples/100 tests per hour up to 67 samples/200 tests per hour up to 267/800 (c4000), 400/1200 (c8000), 600/1800 (c16000), 33/100 (i1000sr), 67/200 (i2000sr)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/no onboard/no onboard/noLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yes noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator yes yes, AbbottLink yes, AbbottLinkOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — — —

Onboard maintenance records/Maintenance training demo module yes/yes yes/yes yes/yes

List price/Targeted bed size or daily volume — — —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes yes/yes yes/yes

Distinguishing features (supplied by company)

Note: a dash in lieu of an answer means company did not answer question or question is not applicable

streamlined workload management; continuous access to reagents, samples, and supplies; 65-sample load capacity; 13 universal bays, 7 customizable priority bays; refrigerated reagent carousel with 25 × 100 test-kit sizes; reagents stable onboard up to 30 days; priority tests; 18-minute turnaround time on stat assays

Chemiflex technology delivers excellent sensitivities and extended linearities; RSH allows priority and routine samples to be processed simultaneously without compromising stats; refer to operations manual for operational precautions, limitations, and hazards; class 1 laser product

integration of CC and IA without compromising stat turnaround time, results, or throughput because of patented SmartWash technology, which minimizes carryover to <0.1 ppm; reagent capacity of 93 assays, with sample load up to 367; refer to operations manual for operational precautions, limitations, and hazards


JUNE 2016 | CAP TODAY 31


JUNE 2016 page 31

Part 2 of 21 Alere Alere AlereBeata Blyskal [email protected] Beata Blyskal [email protected] Beata Blyskal [email protected]


2 Research Way, Princeton, NJ 08540 2 Research Way, Princeton, NJ 08540 2 Research Way, Princeton, NJ 08540609-627-8042 www.alere.com 609-627-8042 www.alere.com 609-627-8042 www.alere.com

Name of instrument/First year sold/Where designed Agility/2012/U.S. DS2/2007/U.S. DSX/2004/U.S.Country where manufactured/Where reagents manufactured U.S./worldwide U.S./worldwide U.S./worldwideNumber of units in clinical use in U.S./Outside U.S. 50/50 800/1,500 1,200/1,800Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack batch/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 50 × 36/8.6 26 × 21 × 27/3.79 32 × 42 × 36/7

Tests available on instrument in U.S. open system, tests provided by various manufacturers open system, tests provided by various manufacturers open system, tests provided by various manufacturersTests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — —Tests in development — — —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit 1 per well 1 per well 1 per wellNumber of wells in microplate 96 (minimum: 1 strip; maximum: 12 full plates) 96 (minimum: 1; maximum: 96) 96 (minimum: 1; maximum: 96)

Methods supported/Separation methods enzyme immunoassay/coated microplate wells enzyme immunoassay/coated microwell enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 16 assay dependent (24 control positions) assay dependent (33 control positions)Number of different assays programmed, calibrated at once 12 assay dependent (24 control positions) assay dependent (33 control positions)Number of user-definable (open) channels unlimited unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

16/96 assay dependent (18 reagent positions)/96 assay dependent (24 reagent positions)/96

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes, 2 mL control vials (other reagents are pour off) yes, 2 mL control vials (other reagents are pour off)Reagents barcoded/Information in barcode yes/lot information no/— no/—

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none, uses disposable tips yes/none, uses disposable tips yes/none, uses disposable tipsWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/200+ continuous load/12+ continuous load assay dependent/100/assay dependent assay dependent/98/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquid

Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—

Minimum specimen volume required 10 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/150 µL 10 µL/50 µL 5 µL/50 µL

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—

Noise generated — — —

Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm diameter, 45–100 mm depth/no yes/10–16 mm diameter, 40–100 mm depth/no yes/10–16 mm diameter, 40–100 mm depth/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A — — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes no/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yes

Clot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —

Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/per plate no/within each run no/within each runMultipoint calib. supported/Multiple calibs. stored for same assay no/no no/no no/no

How often QC required per plate with every assay with every assayOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no no/yes no/yes

Automatic shutdown/Startup is programmable/Startup time yes/yes/15 minutes yes/yes/5 minutes yes/yes/5 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— assay dependent/— assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.) yes (Cerner, Sunquest, Soft, Orchard, etc.)LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (host query) yes (host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours (contract dependent) 24 hours (contract dependent) 24 hours (contract dependent)Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <15 minutes; weekly: <30 minutes; monthly: <1 hour daily: 5 minutes; weekly: 20 minutes; monthly: 20 minutes daily: 10 minutes; weekly: 20 minutes; monthly: 20 minutesOnboard maintenance records/Maintenance training demo module no/no no/no no/no

List price/Targeted bed size or daily volume —/various —/various —/variousAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/— yes/— yes/—



SmartKit, direct-load reagents can be loaded at any time, in any order, thus reducing preanalytic time by more than 60% of traditional ELISA automation systems; the 2-D barcode on each SmartKit is detected, loaded, and tracked in real time, continuously; open platform capacity allows for a very flexible test menu to automate Alere’s ~100 ELISA assays along with any other ELISA manufacturer and eliminates carryover possibility with disposable tips

combined with the Alere ELISA product line and the ability to automate enteric assays and front-end dilute Athena Multi-Lyte assays, the DS2 provides an efficient, open, fully automated solution for customers looking for laboratory automation

open DSX platform enables customers to run many ELISA-based assays; modular design allows users to customize system to unique needs; work list load wizard for easy setup; shows graphically where to place reagents, samples, and plates at beginning of each run; complete daily maintenance in less than 5 minutes, including removal of consumables and rinsing washer




JUNE 2016 page 32

Part 3 of 21 Awareness Technology Awareness Technology Beckman CoulterJamie Ristaino [email protected] Jamie Ristaino [email protected] Sharon Stieg [email protected]


1935 SW Martin Highway, Palm City, FL 34990 1935 SW Martin Highway, Palm City, FL 34990 250 S. Kraemer Blvd., Brea, CA 92821772-283-6540 www.awaretech.com 772-283-6540 www.awaretech.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed ChemWell Fusion/2014/U.S. ChemWell 2910/1998/U.S. Access, Access 2 Immunoassay System/2001/U.S.Country where manufactured/Where reagents manufactured U.S./— U.S./— U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. 0/10+ 80+/4,350+ >2,000/>2,500Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack continuous random access/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 16 × 34 × 20/4 16 × 34 × 20/4 18.5 × 39 × 24/6.5

Tests available on instrument in U.S. unlimited (open system) unlimited (open system) cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries unlimited (open system) unlimited (open system) HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgMTests in development — — AMHTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes noNumber of each analyte performed in separate disposable unit up to 12 up to 12 —Number of wells in microplate minimum strip: 8; maximum full plate: 96 minimum strip: 8; maximum full plate: 96 —

Methods supported/Separation methods enzyme immunoassay (ELISA) and CLIA/coated microwell plate, strips

enzyme immunoassay/coated microwell chemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously up to 12 up to 12 24Number of different assays programmed, calibrated at once unlimited unlimited 24Number of user-definable (open) channels unlimited unlimited 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

27/assay dependent 27/assay dependent 24/100 tests per kit; 50 tests per cartridge

Shortest/Median onboard reagent stability/Refrigerated onboard assay dependent/assay dependent/yes (10°C below ambient) assay dependent/assay dependent/yes (10°C below ambient) 14 days/28 days/yes (3°–10°C)

Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode no/— no/— yes/specific cartridge ID, expiration date, lot number, unique

reagent pack ID numberSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero no/zero no/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/96/12 assay dependent/96/12 up to 180 based on consumable capacity/60/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid no/liquid

Uses disposable cuvettes/Maximum number stored yes/96 yes/96 yes/294Uses washable cuvettes/Replacement frequency yes/assay dependent yes/assay dependent no/—

Minimum specimen volume required 2 µL 2 µL specimen container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 2 µL/— 2 µL/— 5 µL/100 µLSupplied with UPS (backup power)/Requires floor drain no/no no/no no/noRequires dedicated water system/Water consumption no/— no/— no/—

Noise generated — — <70 decibels

Has dedicated pediatric sample cup/Dead volume no/— no/— yes/100 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 × 100 mm/no yes/12 × 100 mm/no yes/12 × 75, 13 × 75 and 100, 16 × 75 and 100/no

Sample barcode reading capability/Autodiscrimination no/— no/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A — — yes

Onboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection no/no no/no yes/yesAutomatic detection of adequate reagent or specimen yes yes yes

Clot detection/Reflex testing capability no/yes no/yes yes/yes (Access 2 only)Hemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no no/no

Sample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes no/no

Time between initial result and reaspiration of sample for rerun assay dependent assay dependent 36 seconds Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency yes/assay dependent yes/assay dependent no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required shortest interval: each run; longest: daily shortest interval: each run; longest: daily 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yes

Automatic shutdown/Startup is programmable/Startup time yes/yes/2 minutes yes/yes/2 minutes no/no/remains in ready mode

Stat time to completion of βhCG test assay dependent assay dependent 15 minutesTime delay from ordering stat test to aspiration of sample 30 seconds 30 seconds ≥36 seconds Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— assay dependent/— 33/100 (36 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (included) onboard/yes (included) onboard/yesLIS interfaces up and running in active user sites — — all major LIS vendorsLIS interface operates simultaneously with running assays no no yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer within 48 hours within 48 hours —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <10 minutes; weekly: <10 minutes;

monthly: <10 minutesdaily: <10 minutes; weekly: <10 minutes; monthly: <10 minutes

daily: 15 minutes; weekly: 30 minutes

Onboard maintenance records/Maintenance training demo module no/no no/no yes (Access 2 only)/online help with maintenance instructions

List price/Targeted bed size or daily volume $29,000/up to 500 tests per day $25,000/up to 500 tests per day $149,800/all volumes and hospital sizesAnnual service contract cost (24 hours/7 days) $4,500 $4,000 —Training provided with purchase/Advanced operator training 3 days on site/no 3 days on site/no yes/yes (Access 2 only)



dual use as random-access ELISA and CLIA analyzer, capable of performing ELISA and CLIA on the same microwell plate using 8-well microwell strips

dual use as random-access biochemistry analyzer when not in EIA mode; optional reagent cooling module

ability to network up to four Access 2 systems using one LIS interface with remote diagnostics; fully automated user-defined reflex testing; continuous random-access benchtop analyzer




JUNE 2016 page 33

Part 4 of 21 Beckman Coulter Beckman Coulter Beckman CoulterSharon Stieg [email protected] Sharon Stieg [email protected] Sharon Stieg [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed UniCel DxI 600 Access Immunoassay System/2007/U.S. UniCel DxI 800 Access Immunoassay System/2003/U.S. UniCel DxC 600i Synchron Access Clinical System/2006/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. >200/>150 >500/>1,000 >449/>150Operational type/Model type/Sample handling system continuous random access/floor standing/rack, direct track

samplingcontinuous random access/floor standing/rack, direct track sampling

continuous random access/floor standing/rack-closed tube

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 67 × 61.5 × 37.5/16.02 67 × 67.5 × 37.5/17.6 62 × 128 × 48/42.7

Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others

cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others


Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg

confirmatory, CMV IgG, CMV IgM, rubella IgMHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

Tests in development AMH AMH AMHTests not available on other manufacturers’ analyzers — — —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —

Methods supported/Separation methods chemiluminescence/magnetic particle chemiluminescence/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particleNumber of different measured assays onboard simultaneously 50 50 89Number of different assays programmed, calibrated at once 50 50 89Number of user-definable (open) channels — 0 100Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

50/100 and 300 tests per kit; 50 tests per cartridge 50/100 and 300 tests per kit; 50 tests per cartridge 89/100 tests per kit (immunoassay); 300 tests per container (general chemistry)

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (3°–10°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, number of available tests, expiration

date, lot number, calibration expiration, within lot calibrationyes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 180–240 based on consumable capacity/60/assay dependent 180–240 based on consumable capacity/120/

assay dependent60/76/assay dependent

System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquid

Uses disposable cuvettes/Maximum number stored yes/1,000 yes/>1,000 yes/125Uses washable cuvettes/Replacement frequency no/— no/— yes/—Minimum specimen volume required specimen container dependent specimen container dependent container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/80 µL 5 µL/160 µL 3 µL/20 µL (general chemistry)Supplied with UPS (backup power)/Requires floor drain no/no no/no yes/yesRequires dedicated water system/Water consumption no/— no/— yes/16 L per hour

Noise generated <65 decibels <60 decibels —

Has dedicated pediatric sample cup/Dead volume yes/100 µL yes/100 µL yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 × 75, 13 × 75 and 100, 16 × 75, 85, and 100 mm/no yes/12 × 75, 13 × 75 and 100, 16 × 75, 85, and 100 mm/no yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yes

Onboard test auto inventory (determines volume in container) no no yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yes (general chemistry)Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no yes/yes

Time between initial result and reaspiration of sample for rerun 36 seconds 36 seconds chemistry dependent Autocalibration or autocalibration alert yes yes —Number of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yes

How often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample 18 seconds 18 seconds 1 minute (general chemistry)Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

—/200 (18 seconds) ≤133/≤400 (9–18 seconds) 90/720 (40 seconds) (general chemistry)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/yes optional add-on/yes (additional cost)LIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/yes yes/yes/validate for the DxC 600i

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <10 minutes daily: <10 minutes —Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $199,500/200–300 beds or 100–300 tests per day $325,000/300+ beds or >400 tests per day $325,000/moderate volume, <300 samples per dayAnnual service contract cost (24 hours/7 days) — — per negotiated contractTraining provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



integrates with UniCel DxC chemistry systems; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability

high-throughput immunoassay analyzer; integrates with UniCel DxC chemistry systems; uses chemiluminescent technology; allows operators to load consumables on the fly, without interacting with the system; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests on one system; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

JUNE 2016 page 34




Part 5 of 21 Beckman Coulter Beckman Coulter Beckman CoulterSharon Stieg [email protected] Sharon Stieg [email protected] Sharon Stieg [email protected]


250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821 250 S. Kraemer Blvd., Brea, CA 92821714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com 714-961-3711 www.beckmancoulter.com

Name of instrument/First year sold/Where designed UniCel DxC 660i Synchron Access Clinical System/2009/U.S. UniCel DxC 680i Synchron Access Clinical System/2009/U.S. UniCel DxC 860i Synchron Access Clinical System/2009/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland U.S./U.S., France, Ireland U.S./U.S., France, IrelandNumber of units in clinical use in U.S./Outside U.S. >40/>20 5/13 >10/>25Operational type/Model type/Sample handling system continuous random access/floor standing/

rack-closed tubecontinuous random access/floor standing/ rack-closed tube

continuous random access/floor standing/ rack-closed tube

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 147 × 48/49 68 × 153 × 48/51 68 × 155 × 48/51.7

Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR, vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others




confirmatory, CMV IgG, CMV IgM, rubella IgMHAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

HAV Ab, HAV IgM, HBc Ab, HBc IgM, HBs Ab, HBsAg, HBsAg confirmatory, CMV IgG, CMV IgM, rubella IgM

Tests in development AMH AMH AMHTests not available on other manufacturers’ analyzers — — —


Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particle chemiluminescence, enzyme immunoassay/magnetic particleNumber of different measured assays onboard simultaneously 115 115 120Number of different assays programmed, calibrated at once 115 115 120Number of user-definable (open) channels 100 100 100Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

115/100 tests per kit (immunoassay); 300 tests per container (general chemistry)



Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (3°–10°C) 14 days/28 days/yes (2°–10°C) 14 days/28 days/yes (2°–10°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, number of available tests, expiration

date, lot number, calibration expiration, within lot calibrationyes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

yes/specific cartridge ID, number of available tests, expiration date, lot number, calibration expiration, within lot calibration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm yes/<10 ppm yes/<10 ppmWalkaway capacity in minutes/Specimens/Tests, assays 60/76/assay dependent 60/76/assay dependent 60/112/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/125 yes/125 yes/125Uses washable cuvettes/Replacement frequency yes/— yes/— yes/—Minimum specimen volume required container dependent container dependent container dependentMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/20 µL (general chemistry) 3 µL/20 µL (general chemistry) 3 µL/20 µL (general chemistry)Supplied with UPS (backup power)/Requires floor drain yes/yes yes/yes yes/yesRequires dedicated water system/Water consumption yes/up to 16 L per hour yes/up to 16 L per hour yes/up to 16 L per hour

Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/— yes/— yes/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 92 and 75, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yesSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes (general chemistry) yes/yes (general chemistry) yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes yes/yes yes/yes

Time between initial result and reaspiration of sample for rerun chemistry dependent chemistry dependent chemistry dependentAutocalibration or autocalibration alert — — —Number of calibrators required for each analyte assay dependent assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency no/28 days no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yes

How often QC required 24 hours 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode no/no/remains in ready mode no/no/remains in ready mode

Stat time to completion of βhCG test 15 minutes 15 minutes 15 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) 1 minute (general chemistry) 1 minute (general chemistry)Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry) 90/720 (40 seconds) (general chemistry)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface — — —LIS interfaces up and running in active user sites — — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems yes, Beckman Coulter automation systems yes, Beckman Coulter automation systemsModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/validate for the DxC 680i yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — — —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — — —Onboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/online help with maintenance instructions yes/online help with maintenance instructions

List price/Targeted bed size or daily volume $575,000/high volume, 300–750 samples per day $610,000/high volume, 300–750 samples per day $615,000/high to very high volume, 500–1,500 samples per day

Annual service contract cost (24 hours/7 days) per negotiated contract per negotiated contract per negotiated contractTraining provided with purchase/Advanced operator training yes/yes yes/yes yes/yes



performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

performs parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

parallel processing of immunoassay and chemistry tests; ClozCap technology (closed-tube aliquot and closed-tube sampling) eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability




JUNE 2016 page 36

Part 6 of 21 Beckman Coulter bioMérieux Inc. bioMérieux Inc.Sharon Stieg [email protected] Customer Service Team [email protected] Customer Service Team [email protected]


250 S. Kraemer Bvld., Brea, CA 92821 100 Rodolphe St., Durham, NC 27712 100 Rodolphe St., Durham, NC 27712714-961-3711 www.beckmancoulter.com 800-682-2666 www.biomerieux-usa.com 800-682-2666 www.biomerieux-usa.com

Name of instrument/First year sold/Where designed UniCel DxC 880i Synchron Access Clinical System/2008/U.S. VIDAS 3/2013/Italy VIDAS Immunoassay Analyzer/1991/U.S.Country where manufactured/Where reagents manufactured U.S./U.S., France, Ireland Italy/France Italy/FranceNumber of units in clinical use in U.S./Outside U.S. >40/>150 — 2,200/25,000Operational type/Model type/Sample handling system continuous random access/floor standing/rack-closed tube random access, continuous random access/benchtop/rack batch, random access/benchtop/—Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 161 × 48/53.7 24 × 29.5 × 25.5/5.2 VIDAS 30: 16 × 32 × 2/4.5; MiniVIDAS: 21 × 21 × 17/4Tests available on instrument in U.S. cortisol, total IgE, EPO, ferritin, folate, intrinsic factor Ab, sTfR,

vitamin B12, intact PTH, ostase, CK-MB, digoxin, myoglobin, ultrasensitive insulin, rubella IgG, toxo IgG, toxo IgM II, DHEA-S, estradiol, hFSH, hLH, inhibin A, progesterone, prolactin, SHBG, testosterone, total βhCG, unconjugated estriol, fast hTSH, free T3, total T4, thyroglobulin, TPOAb, PSA, free PSA, BR-GI-OV monitors, troponin I, vitamin D, and many others

procalcitonin, D-dimer, lyme IgG & IgM, measles, mumps, rubella, varicella, HCG, H. pylori

procalcitonin, TSH, FT4, T4, T3, total PSA, HCG, LH, FSH, estradiol 2, prolactin, progesterone, testosterone, C. difficile GDH, D-dimer, troponin I, CKMB, C. difficile toxin A&B, mumps IgG, rubella IgG, varicella zoster virus IgG, lyme IgG & IgM, H. pylori, toxo competition, toxo IgG, toxo IgM, toxo IgG avidity, CMVM, CMVG, measles IgG, others


confirmatory, CMV IgG, CMV IgM, rubella IgMferritin; NT-proBNP; CK-MB; high sensitive troponin I; troponin I Ultra; X protein C, von Willebrand’s factor (allergen-specific IgG for research only); LH, FSH, estradiol II, progesterone, prolactin, testosterone, cor-tisol S; Staller test, Stallertroph, Stallergy; TSH, FT4, T3, T4, TSH3G, anti-TPO, anti-TG, FT3; toxo; TSPA; AFP, CEA-(S), FPSA, CA 15-3, CA 19-9, CA 125-II; CMV, EBV, HIV, HBs Ag, anti-HBs, anti-HBc total, HBc IgM, HBe-anti-HBe, HAV IgM, anti-HAV total, anti-HCV, rotavirus; C. difficile, H. pylori IgG, vitamin D, total IgE, others

HBs Ag, anti-HBs total, anti-HBc total, anti-HBc IgM, anti-HBe, HAV IgG, anti-HAV total, HIV duo, myoglobin, others

Tests in development AMH — vitamin DTests not available on other manufacturers’ analyzers — PCT, lyme IgG & IgM —

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — 1 test per strip 1 test per stripNumber of wells in microplate — — —Methods supported/Separation methods chemiluminescence, enzyme immunoassay/magnetic particle fluorescence, enzyme immunoassay, enzyme immunoassay

coated, solid phase receptacle pipetting device/—fluorescence, enzyme immunoassay, enzyme immunoassay coated, solid phase receptacle pipetting device/—

Number of different measured assays onboard simultaneously 120 12 MiniVIDAS: 12; VIDAS: 30Number of different assays programmed, calibrated at once 120 total menu total menuNumber of user-definable (open) channels 100 — —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set


unit-dose format 30 or 60/30 or 60 unit-dose format 30 or 60/—

Shortest/Median onboard reagent stability/Refrigerated onboard 14 days/28 days/yes (2°–10°C) —/—/no —/—/noMultiple reagent configurations supported yes yes noReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/specific cartridge ID, number of available tests, expiration

date, lot number, calibration expiration, within lot calibrationyes/assay name, lot number, calibration, expiration yes/assay name, lot number, calibration, expiration

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/<10 ppm no/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 60/112/assay dependent assay dependent/27/12 assay dependent/12–30/12–30System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/dryUses disposable cuvettes/Maximum number stored no/125 no/32 dilution cups onboard no/—Uses washable cuvettes/Replacement frequency yes/— no/— no/—Minimum specimen volume required container dependent 100–200 µL, dependent on assay 100–200 µL, dependent on assayMinimum sample volume aspirated precisely at once/Minimum dead volume 3 µL/20 µL (general chemistry) 100 µL, dependent on assay/100 µL, dependent on assay 100 µL, dependent on assay/—Supplied with UPS (backup power)/Requires floor drain yes/— yes/no yes/noRequires dedicated water system/Water consumption yes/up to 16 L per hour no/— no/—


Has dedicated pediatric sample cup/Dead volume yes/— yes/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75 and 100, 15 × 75 and 92, 16 × 100 mm/yes yes/16 x 100 mm, 13 x 100 mm, 13 x 75 mm, 12 x 75 mm,

Nalgen cups size: 13, 5 x 38, 1 mm/nono/—/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/noBarcode placement per CLSI standard Auto2A yes yes noOnboard test auto inventory (determines volume in container) yes no noMeasures number of tests remaining/Short sample detection yes/yes no/yes no/noAutomatic detection of adequate reagent or specimen yes yes noClot detection/Reflex testing capability yes/yes yes/yes no/noHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes (general chemistry) yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/— yes/no no/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/yes no/no no/no

Time between initial result and reaspiration of sample for rerun chemistry dependent — —Autocalibration or autocalibration alert — yes yesNumber of calibrators required for each analyte assay dependent assay dependent —Calibrants can be stored onboard/Average calibration frequency no/28 days yes/14 or 28 days no/14 or 28 days, assay dependentMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes no/yes

How often QC required 24 hours as per local policy shortest interval: 8 hours; longest: 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yes

Automatic shutdown/Startup is programmable/Startup time no/no/remains in ready mode yes/yes/5 minutes no/no/always remains readyStat time to completion of βhCG test 15 minutes 30 minutes 30 minutesTime delay from ordering stat test to aspiration of sample 1 minute (general chemistry) no delay no delayThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

90/720 (40 seconds) (general chemistry) 12/36 (20 minutes) —/VIDAS: 20; MiniVIDAS: 8; VIDAS: 60; MiniVIDAS: 24

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface — onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites — Misys, Medtech, McKesson, Advanced Lab Systems, Citation,

Cerner, Dawning, Geneysis, Compulab, othersMisys, Medtech, McKesson, Advanced Lab Systems, Citation, Cerner, Dawning, Geneysis, Compulab, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download)Interface available (or will be) to auto specimen handling system yes, Beckman Coulter automation systems no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — within 24 hours within 24 hoursMean time between failures/To repair failures — 385 days/— VIDAS: 860 days; MiniVIDAS: 1,200 days/—Average time to complete maintenance by lab personnel — weekly: 10–15 minutes weekly: 10–15 minutesOnboard maintenance records/Maintenance training demo module yes/online help with maintenance instructions yes/no yes (includes audit trail)/—

List price/Targeted bed size or daily volume $650,000/high to very high volume, 750–2,250 samples per day — —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training — — —Distinguishing features (supplied by company)


performs parallel processing of immunoassay and chemistry tests; ClozCap technology eliminates manual processes; chemistry reagent packs are identical across the UniCel family of systems; offers ProService remote diagnostic service capability

routine batch testing as well as emergency stat testing, single-dose assay format readily adaptable to batch or single test runs; full traceability with preanalytic automation with barcoding throughout, bi-directional connectivity and remote support; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover

routine batch testing as well as emergency stat testing; ELISA methodology; dual-function combination solid phase and pipetting device results in no fluid contact with instrument or sample carryover; single-dose assay format readily adaptable to batch or single test runs




JUNE 2016 page 37

Part 7 of 21 Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics GroupGreg Stewart [email protected] Greg Stewart [email protected] Maria Crisostomo [email protected]


4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547 4000 Alfred Nobel Drive, Hercules, CA 94547800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-224-6723 (800-2BIO-RAD) www.bio-rad.com

Name of instrument/First year sold/Where designed PR4100 Microplate Reader/2012/Austria PhD Ix System/2012/France BioPlex 2200/2006/AustraliaCountry where manufactured/Where reagents manufactured Austria/U.S. France/U.S. Australia/U.S.Number of units in clinical use in U.S./Outside U.S. 85/10 62/— —Operational type/Model type/Sample handling system batch/benchtop/— batch/benchtop/reagent rack continuous random access/floor standing/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet — 30 × 36 × 27/16 58 × 72 × 34/12

Tests available on instrument in U.S. HIV, HBsAg, HBs, HAV, HAV IgM, HBc, HBc IgM, HCV, syphilis, measles, mumps, VZV, lyme, toxoplasma, ANA, SSA, SSB

open system, method file consists of autoimmune and infectious disease assays, both EIA and IFA methodologies

ANA screen, anti-dsDNA (quantitative), anti-SS-A, anti-SS-B, anti-Sm/RNP, anti-Sm, anti-RNP, anti-Scl-70, anti-Jo-1, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-CCP, anti-GBM IgG, anti-MPO IgG, anti-PR3 IgG, EBV-nuclear antigen IgG, EBV-viral capsid antigen IgG, EBV-early antigen diffuse IgG, EBV-viral capside antigen IgM, heterophile IgM, syphilis IgG, toxoplasma gondii IgG, cytomegalovirus IgG, rubella IgG (quantitative), cytomegalovirus IgM, rubella IgM, measles IgG, mumps IgG, rubella IgG (qualitative), varicella-zoster virus IgG, HSV-1 IgG, HSV-2 IgG, anti-deamidated gliadin (DGP) IgA, anti-tissue transglutaminase (tTG) IgA, anti-DGP IgG, anti-tTG IgG, anti-cardiolipin IgA, anti-beta2 glycoprotein (β2GPI) IgA, anti-cardiolipin IgG, anti-β2GPI IgG, anti-cardiolipin IgM, anti-β2GPI IgM, 25-OH vitamin D, HIV Ag-Ab screen, HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — — syphilis IgM, toxoplasma gondii IgMTests in development — — syphilis total, lyme borreliosisTests not available on other manufacturers’ analyzers — — heterophile antibodies

Fully automated microplate system no no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate 96 (minimum: 1; maximum: 8) 96 (minimum: 1; maximum: 96) —

Methods supported/Separation methods enzyme immunoassay/coated microwell fluorescence, enzyme immunoassay/coated microwell bead flow cytometric (multiplex)/magnetic particleNumber of different measured assays onboard simultaneously — 8 enzyme immunoassay or 4 IFA 48Number of different assays programmed, calibrated at once — 8 enzyme immunoassay or 4 IFA 48Number of user-definable (open) channels — no limit —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

— up to 8 different assays/96 48/100 (HIV and vitamin D: 48/200)

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 4 hours/—/no 30 days/30 days/yes (2°–8°C)Multiple reagent configurations supported no yes noReagent container placed directly on system for use — yes yesReagents barcoded/Information in barcode — no/— yes/kit type, lot number, kit serial number

Same capabilities when 3rd-party reagents used/Susceptibility to carryover — yes/— no/<1 ppmWalkaway capacity in minutes/Specimens/Tests, assays — —/192/8 EIA or 4 IFA 480 minutes/800/9,600System is open (homebrew methods can be used)/Liquid or dry system yes/dry yes/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— yes/800Uses washable cuvettes/Replacement frequency no/— — no/—Minimum specimen volume required 70 µL 150 µL 5 µLMinimum sample volume aspirated precisely at once/Minimum dead volume — 1 µL/150 µL 5 µL/220 µLSupplied with UPS (backup power)/Requires floor drain no/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/0.5 L per hour

Noise generated — — <67 decibels

Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes no/—/— yes/12–13 mm diameter, 75–100 mm height/no yes/10–16 mm diameter, 41–100 mm height/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A — yes yesOnboard test auto inventory (determines volume in container) — no yesMeasures number of tests remaining/Short sample detection — no/no yes/yesAutomatic detection of adequate reagent or specimen — yes yesClot detection/Reflex testing capability — no/no yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation — no/no no/noDilution of patient samples onboard/Automatic rerun capability — yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no —

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert — no yesNumber of calibrators required for each analyte — assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency — no/each run no/30 daysMultipoint calib. supported/Multiple calibs. stored for same assay — yes/no yes/yes

How often QC required — each run 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte — no/no yes/yes

Automatic shutdown/Startup is programmable/Startup time — no/no/<5 minutes no/yes/10 minutes


— assay dependent/— 100/100 (36 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC — no/no yes/yesData-management capability/Instrument vendor supplies LIS interface — onboard/— onboard/noLIS interfaces up and running in active user sites — — Antrim, CCA, Cerner Classic/Millennium, CHCS/SAIC, Data

Innovations, Labsoft, Meditech, Orchard, Rubicon, SCC, Schuyler, SOFT, Sunquest/Misys

LIS interface operates simultaneously with running assays — yes yesBidirectional interface capability — yes (broadcast download and host query) yesInterface available (or will be) to auto specimen handling system — no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

— no/no/no yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator — no noOn-site response time of service engineer — 24 hours <24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel — daily: <5 minutes; weekly: 15 minutes; monthly: 30 minutes daily: 5 minutes; weekly: 30 minutesOnboard maintenance records/Maintenance training demo module — no/no yes/noList price/Targeted bed size or daily volume — $68,000/all bed sizes —/as many as 800 samples per dayAnnual service contract cost (24 hours/7 days) — $6,700 —Training provided with purchase/Advanced operator training — 2 days on site/no 5 days at Bio-Rad/no



— open platform with assay programming wizard; bidirectional LIS with broadcast download, capable of running IFA and EIA; accurate down to 1 µL, IFA hyperwash for cleaner backgrounds, precise well-to-well timing; networking capabilities for multiple workstations

full random access automation; three internal quality control beads run simultaneously with each sample; innovative multiplex chemistry

JUNE 2016 page 38




Part 8 of 21 Bio-Rad Laboratories Clinical Diagnostics Group DiaSorin DiaSorinGreg Stewart [email protected] Bobbi Keefe [email protected] Bobbi Keefe [email protected]


4000 Alfred Nobel Drive, Hercules, CA 94547 1951 Northwestern Ave., Stillwater, MN 55082 1951 Northwestern Ave., Stillwater, MN 55082800-224-6723 (800-2BIO-RAD) www.bio-rad.com 800-328-1482/651-439-9710 www.diasorin.com 800-328-1482/651-439-9710 www.diasorin.com

Name of instrument/First year sold/Where designed EVOLIS/2001/Germany LIAISON XL/2010/Italy ETI-MAX 3000/2002/GermanyCountry where manufactured/Where reagents manufactured Germany/U.S. Germany/Italy, Germany, U.S. Germany/U.S., ItalyNumber of units in clinical use in U.S./Outside U.S. 300/1,350 >300/>1,600 —Operational type/Model type/Sample handling system batch/benchtop/rack batch, random access, continuous random access/floor

standing/rackbatch, random access/benchtop/rack

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 37 × 44 × 30/10 59 × 59 × 36/14.6 40 × 45 × 30/10

Tests available on instrument in U.S. HIV Ab, HIV Ab/Ag, HBsAg, HBs, HBc, HBc M, HAV, HAV M 25 hydroxyvitamin D total, treponema IgG/IgM, anti-HAV total, measles IgG, mumps IgG, Borrelia burgdorferi, EBV IgM, VCA IgG, EA IgG, EBNA IgG, VZV IgG, rubella IgG, rubella IgM testosterone, estradiol, TSH, HSV-1 type specific IgG, HSV-2 type specific IgG, CMV IgG, direct renin, aldosterone, LH, FSH, intact PTH, toxo IgG, toxo IgM, CMV IgM, insulin, C-peptide, hGH, IGF-1, prolactin, progesterone, hCG, FT3, FT4, 1,25 dihydroxyvitamin D, PTH 1-84

measles IgG, varicella zoster IgG, mumps IgG, H. pylori IgG, Trep-Sure syphilis, ANA screen, ENA 6 screen, anti-dsDNA, anti-Sm, anti-Sm/RNP, anti-SS-A, anti-SS-B, anti-Jo-1, anti-Scl-70, anti-MPO, anti PR3 (cANCA), anti-TPO, anti-cardiolipin, IgG, IgM, others

Tests not available in U.S. but submitted for clearance — — —

Tests not available in U.S. but available in other countries HCV Ab, toxo IgG, toxo IgM, rubella IgG, EBV VCA IgG, EBV VCA IgM, EBV EAD, EBV EBNA, infectious disease serology and autoimmune, others

H. pylori IgG, Ca 125, Ca 15-3, Ca 19-9, TPA-M, AFP, CEA, PSA, fPSA, S100, NSE, calprotectin, Brahms procalcitonin II, many others

—

Tests in development — sclerostin, FGF-23 —Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes no yesNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate minimum strip: 1; maximum full plate: 96 — minimum strip: 1, 8 wells; maximum full plate: 96 wells, can

accommodate up to 7 plates at a time

Methods supported/Separation methods enzyme immunoassay/coated microwell chemiluminescence/magnetic particle enzyme immunoassay/coated microplateNumber of different measured assays onboard simultaneously 4–8 25 openNumber of different assays programmed, calibrated at once 4–8 25 openNumber of user-definable (open) channels — 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

4/96 25/100 volume dependent/—

Shortest/Median onboard reagent stability/Refrigerated onboard 30 minutes/assay dependent/— 7 days/28 days/yes (12°C) no/no/noMultiple reagent configurations supported yes no yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/— yes/quantity, stability, lot number, and more yes/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/no (disposable tips) no/no yes/noWalkaway capacity in minutes/Specimens/Tests, assays varies by assay/180/4 7 days/120/3,000 assay dependent/180/variableSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored microplates/— yes/1,000 no/—Uses washable cuvettes/Replacement frequency microplates/— no/— no/—Minimum specimen volume required 0.2 µL assay dependent 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/200 µL 5 µL/150 µL 10 µL/200 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/— yes/noRequires dedicated water system/Water consumption no/— no/— no/noNoise generated 60 decibels — —Has dedicated pediatric sample cup/Dead volume no/— yes/50 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/up to 16 mm diameter, up to 100 mm height/no yes/10–16 mm diameter/no yes/multiple/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes/yesBarcode placement per CLSI standard Auto2A no yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection no/no yes/yes yes/yesAutomatic detection of adequate reagent or specimen no yes yesClot detection/Reflex testing capability yes/no yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/yes yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — 2 minutes —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay dependent 2 varies per kitCalibrants can be stored onboard/Average calibration frequency no/with each run yes/1–4 weeks no/each runMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/noHow often QC required user determined 24 hours per runOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/5 minutes yes/no/8 minutes no/yes/5 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — 2 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/— 57/171 (21 seconds) assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes onboard/no yes/yesLIS interfaces up and running in active user sites yes — yes

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download) yes (broadcast download and host query) yesInterface available (or will be) to auto specimen handling system no yes (Inpeco) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/no/no yes/yes/yes no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours 24 hours 24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 5 minutes; monthly: 60 minutes weekly: 10 minutes; monthly: 10 minutes daily: 5 minutes; weekly: 30 minutesOnboard maintenance records/Maintenance training demo module yes/no yes/no yes/no

List price/Targeted bed size or daily volume $85,000/30–500 tests per day —/>400 beds —/all bed sizes, all test volumesAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 5 days in Redmond, Wash./no yes/yes 3 days/yes



fully automated microplate system that meets a high level of safety (positive identification of samples, reagents, microplates, clot detection, no contamination), flexibility (reagents and microplates), and productivity (4–6 plates, up to 180 specimens, 4–8 different assays can be processed simultaneously)

secure traceability of all processes, status of reagents, and consumables; disposable pipette tips prevent sample carryover; clot detection, aspiration, and dispensation verification; single-cavity reaction cuvettes; no daily maintenance; instrument monitors maintenance needs; flash chemiluminescence technology with paramagnetic microparticle solid phase

multiple assays on a plate; Windows 2000 software; continuous loading of samples, reagents, and microplates; primary tube sampling; bidirectional interface




JUNE 2016 page 40

Part 9 of 21 DiaSorin Dynex Technologies Dynex TechnologiesBobbi Keefe [email protected] Rich Bahlmann [email protected] Rich Bahlmann [email protected]


1951 Northwestern Ave., Stillwater, MN 55082 14340 Sullyfield Circle, Chantilly, VA 20151 14340 Sullyfield Circle, Chantilly, VA 20151800-328-1482/651-439-9710 www.diasorin.com 703-631-7800 www.dynextechnologies.com 703-631-7800 www.dynextechnologies.com

Name of instrument/First year sold/Where designed LIAISON/1997/Germany DS2/2005/U.S. DSX/2001/U.S.Country where manufactured/Where reagents manufactured Germany/U.S., Italy U.S./worldwide U.S./worldwideNumber of units in clinical use in U.S./Outside U.S. >300/>4,100 800/1,500 1,200/1,800Operational type/Model type/Sample handling system batch, continuous random access/benchtop/rack batch/benchtop/rack batch/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 45 × 96 × 34/10 26 × 21 × 27/3.79 32 × 42 × 36/7

Tests available on instrument in U.S. 25 hydroxyvitamin D total, intact PTH, EBV IgM, EBNA IgG, VCA IgG, EA IgG, toxo IgG, toxo IgM, CMV IgG, CMV IgM, treponema IgG/IgM, VZV IgG, hGH, Borrelia burgdorferi, HAV IgM, HAV total antibodies, rubella IgG, HSV-1 type specific IgG, HSV-2 type specific IgG, insulin, measles IgG, mumps IgG, rubella IgM, IGF-1, testosterone, estradiol, FT4, direct renin, aldosterone, LH, FSH, C-peptide, FT3, prolactin, progesterone, PTH 1-84

open system, tests provided by various manufacturers open system, tests provided by various manufacturers


Tests not available in U.S. but available in other countries avidity, HSV I/II IgM, HSV I/II IgG, β-2-microglobulin, S-100, AFP, ferritin, T3, T4, anti-TG, TG, calprotectin, Brahms procalcitonin II

— —

Tests in development sclerostin, H. pylori IgG, FGF-23 — —

Tests not available on other manufacturers’ analyzers — none none

Fully automated microplate system no yes yesNumber of each analyte performed in separate disposable unit — 1 per well 1 per wellNumber of wells in microplate — 96 (minimum: 1 strip; maximum: 2 full plates) 96 (minimum: 1 strip; maximum: 4 full plates)

Methods supported/Separation methods chemiluminescence/magnetic particle enzyme immunoassay/coated microwell enzyme immunoassay/coated microwellNumber of different measured assays onboard simultaneously 15 assay dependent (24 control positions) assay dependent (33 control positions)Number of different assays programmed, calibrated at once 15 assay dependent (24 control positions) assay dependent (33 control positions)Number of user-definable (open) channels 0 unlimited unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

15/100 assay dependent (18 reagent positions)/96 assay dependent (24 reagent positions)/96

Shortest/Median onboard reagent stability/Refrigerated onboard 7 days/28 days/yes (12°C) —/—/no —/—/noMultiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes, 2 mL control vials (other reagents are pour off) yes (when using custom racks)Reagents barcoded/Information in barcode yes/all lot information no/— yes/lot information when used with custom racksSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/no yes/none (uses disposable tips) yes/none (uses disposable tips)Walkaway capacity in minutes/Specimens/Tests, assays 360/144/1,500 assay dependent/100/assay dependent assay dependent/assay dependent/4+System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/720 no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required assay dependent 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/150 µL 10 µL/— 10 µL/—Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/75 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/—/no yes/10–16 mm diameter, 40–100 mm height/no yes/12–16 mm diameter, 55–100 mm height/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Barcode placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/no yes/—Hemolysis detection-quantitation/Turbidity detection-quantitation no/no — —Dilution of patient samples onboard/Automatic rerun capability yes/yes yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 2 minutes — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte 2 assay dependent assay dependentCalibrants can be stored onboard/Average calibration frequency yes/28 days no/per plate no/per plateMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/noHow often QC required 24 hours per plate per plateOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yes no/stored curve capability no/noAutomatic shutdown/Startup is programmable/Startup time no/no/15 minutes no/no/— no/no/—

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample 2 minutes — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— — —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)LIS interfaces up and running in active user sites Cerner, Soft, others yes yesLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (host query and broadcast download) yes (host query and broadcast download)Interface available (or will be) to auto specimen handling system no — —Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no no/yes/yes no/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24 hours contract dependent contract dependentMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 10 minutes; weekly: 20 minutes;

monthly: 30 minutesdaily: <15 minutes; weekly: <75 minutes; monthly: <5 hours

daily: <15 minutes; weekly: <75 minutes; monthly: <5 hours

Onboard maintenance records/Maintenance training demo module no/no yes/no yes/no

List price/Targeted bed size or daily volume —/all bed sizes, all volumes $51,709/2–4 plates $72,282/4–6 platesAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days on site/yes additional/yes additional/yes



fully automated benchtop analyzer with high throughput; unique menu; up to 15 assays onboard with ready-to-use, reagent-integral, random-access, batch and stat operation

washer synchronization, eliminates plate drift; disposable tips; small footprint

washer synchronization, eliminates plate drift; modular design; disposable tips




JUNE 2016 page 41

Part 10 of 21 Dynex Technologies Erba Diagnostics Fujirebio USRich Bahlmann [email protected] Scott Gillespie [email protected] David Swartz [email protected]


14340 Sullyfield Circle, Chantilly, VA 20151 14100 NW 57 Court, Miami, FL 33014 205 Great Valley Parkway, Malvern, PA 19355703-631-7800 www.dynextechnologies.com 786-683-1522 www.erbadiagnostics.com 844-544-3787 www.fujirebio-us.com/lumipulse

Name of instrument/First year sold/Where designed Agility/2012/U.S., U.K. MAGO 4S/—/Italy Lumipulse G1200/U.S.: 2016; outside U.S.: 2008/JapanCountry where manufactured/Where reagents manufactured U.S./worldwide Italy/U.S. Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 50/50 — 1/1,018Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/rack continuous random access/floor standing/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 50 × 36/8.6 27.5 × 26 × 47.25/— 56 × 45 × 30/32.45

Tests available on instrument in U.S. open system, tests provided by various manufacturers open system: all autoimmune infectious disease ELISA and IFA slide kits

CA125, HE4, vitamin D, ROMA

Tests not available in U.S. but submitted for clearance — — syphilisTests not available in U.S. but available in other countries — — procalcitonin, AFP, CEA, CA 15-3, CA 19-9, PSA, free PSA,

CYFRA, PIVKA-II, ProGRP, SMRP, PLAP, pepsinogen I, pepsinogen II, B2M (S), B2M (U), HBsAg-quant, HBsAb, HBcAb, HBcIgM, HBeAg, HBeAb, HBcrAg, HAVAb, HAVIgM, HIV ½, HIV Ag/Ab, HTLV-I, HBsAg-qual, HCV Ab, HCV Ag, HIV-1p24, C-peptide (S), C-peptide (U), insulin, ferritin, adiponectin-HMW, ApoB48, TSH, FT3, FT4, T3, T4, TgAb, TPOAb, LH, FSH, prolactin, progesterone, testosterone, E2, β-HCG, BNP, IgE, IL-6, KL-6, L-FABP

Tests in development — — AMH, wPTH, HTLV-I/II, troponin I, CK-MB, myoglobin, hTAU, pTAU, β-amyloid

Tests not available on other manufacturers’ analyzers none — LFABP, adiponectin, SMRP, HBcrAg

Fully automated microplate system yes yes noNumber of each analyte performed in separate disposable unit 1 per well 1 analyte per well (or multiple, test dependent) —Number of wells in microplate 96 (minimum: 1 strip; maximum: 12 full plates) 4 x 96 wells, up to 16 slides per run (minimum strip: 8;

full plate: 12 strips)—

Methods supported/Separation methods enzyme immunoassay/coated microplate wells enzyme immunoassay, sample titrations and slides simultaneously with ELISA processing/coated microwell, coated tissue, cell slide

chemiluminescence/magnetic particle

Number of different measured assays onboard simultaneously 12 12 36Number of different assays programmed, calibrated at once 12 up to 20 (analyte dependent) 36Number of user-definable (open) channels unlimited 20 active at a time, unlimited saved on hard drive —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

12/96 up to 20 (analyte dependent)/96 36/14

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no 8 hours/1 day/no 720 hours/30 days/yes (2°–12°C)Multiple reagent configurations supported yes yes noReagent container placed directly on system for use yes yes requires operator prehandling, preparationReagents barcoded/Information in barcode yes/lot information yes/lot expiration date yes/lot number, expiration date, master calibration curve, sequenceSame capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (uses disposable tips) yes/zero no/<0.1 ppmWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/200+ continuous load/12+ continuous load 150/120/384 50/100/24System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/120 no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 10 µL 50 µL pediatric 10–140 µL (assay dependent)Minimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/150 µL 4 µL/35 µL 10 µL/250 µL tube, 100 µL cupSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — 65 deciblesHas dedicated pediatric sample cup/Dead volume no/— yes/35 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm diameter, 45–100 mm depth/no yes/11–15 mm × 75–100 mm/no yes/outer diameter 11.5–16.0 mm, length 75–100 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A — no yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no no/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte assay dependent 1–6, analyte dependent most analytes use 2–3 pointsCalibrants can be stored onboard/Average calibration frequency no/per plate yes/per run no/30 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/no yes/yesHow often QC required per plate each run user definedOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no yes/— —/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/15 minutes yes/yes/5 minutes yes/yes/5 minutes

Stat time to completion of βhCG test — — 30 minutesTime delay from ordering stat test to aspiration of sample — — 1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— 120/360 (2.5 hours) 40/120 tests per hour (30 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (included in instrument price) no/yes (additional cost)LIS interfaces up and running in active user sites yes Cerner, Misys, Orchard, others —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query and broadcast download) yes (host query) yes (host query)Interface available (or will be) to auto specimen handling system no no yes (Inpeco, IDS, Aloka, Hitachi)Modem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer contract dependent 24–48 hours 24–48 hoursMean time between failures/To repair failures — 5 months/3–6 hours >330 days/—Average time to complete maintenance by lab personnel daily: <15 minutes; weekly: <75 minutes; monthly: <5 hours daily: 5 minutes; weekly: 10 minutes daily: 15 minutes; weekly: 45 mintes; monthly: 90 minutesOnboard maintenance records/Maintenance training demo module yes/no no/— no/no

List price/Targeted bed size or daily volume $124,848/8+ plates $72,000 (includes first-year warranty)/30–300 beds $75,000/50–500 bedsAnnual service contract cost (24 hours/7 days) — $8,500 $10,000Training provided with purchase/Advanced operator training additional/yes 2–3 days/yes 2 days/no



reduces hands-on time by more than 60 percent for ELISA testing; tracks all assays, test kits, consumables, reagents, and waste so analyzer can run without interruption

simultaneous ELISA/IFA processing, performs serial twofold dilutions onboard; pre-assay, full strip, plate/reagent/sample volume check; automated system maintenance before and after each run; automated dilution and dispensing of samples and reagents in customized volumes; total automation for all analytical procedural steps (loading of worksheet directly from host or keyboard, positive barcode sample ID, etc.)

unitized immunoreaction cartridge eliminates open bottle stability concerns; 30 minute time to result for all assays; uninterrupted productivity—replenish samples, reagents, and consumables on the fly




JUNE 2016 page 42

Part 11 of 21 Gold Standard Diagnostics Grifols Hycor BiomedicalChristina Brusca [email protected] Micah Majarian [email protected] Richard Hockins [email protected]


2851 Spafford St., Davis, CA 95618 4560 Horton St., Emeryville, CA 94608 7272 Chapman Ave., Garden Grove, CA 92841530-759-8000 www.gsdx.us 800-379-0957 www.grifolsusa.com 800-382-2527 www.hycorbiomedical.com

Name of instrument/First year sold/Where designed ThunderBolt/2012/U.S. Triturus/1999/Spain HYTEC 288 PLUS/outside U.S.: 1998; U.S.: 1999/NetherlandsCountry where manufactured/Where reagents manufactured U.S./— Spain/Spain, U.S., Italy Netherlands/U.S.Number of units in clinical use in U.S./Outside U.S. 100/500 >200/>1,700 >85/>200Operational type/Model type/Sample handling system batch/benchtop/rack batch, continuous random access/benchtop/universal carousel random batches/benchtop/rack roboticsDimensions in inches (H × W × D)/Instrument footprint in sq. feet 17.7 × 25.2 × 22.5/4 28.3 × 41.3 × 34.3/10 29.5 × 42.5 × 27.5/8

Tests available on instrument in U.S. ELISA open system: most U.S. clinically cleared and research-use-only EIA procedures can be programmed; infectious diseases, autoimmune diseases, bone markers, endocrinology, hemostasis, oncology markers, hepatitis, and HIV profiles

total/specific IgE, ANA scr, TG, TPO, dsDNA, RF IgG, RF IgM, RF IgA, PR-3 (c-ANCA), MPO (p-ANCA), anti-mitochondrial, ENA-6 scr., SS-A, SS-B, Sm, Sm/RNP, Scl-70, Jo-1, gliadin IgA & IgG, GBM, GPC, anti-cardiolipin IgG & IgM, anti-cardiolipin scr., β2 BPI IgG, IgA & IgM, user-defined channels


Tests not available in U.S. but available in other countries — — specific IgG, ssDNA, total RF, anti-tissue transglutaminase IgA & IgG, circulating immune complex -C1q and -C3d, CCP

Tests in development — — ANCA profile, centromere

Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit — 8 8 (1 analyte, multiple analytes/screens per well, up to 8

analytes)Number of wells in microplate 96 96 (minimum strip: 1; maximum: 4 full plates) 96 (minimum strip: 1 strip/8 wells; maximum full plate: 12

strips/96 wells)

Methods supported/Separation methods chemiluminescence, enzyme immunoassay/coated microwell enzyme immunoassay, EIA-coated microwell plates, onboard shaker, 4 individually temperature-controlled microplate positions/coated microwell

enzyme immunoassay, tube-based and microplate-based assays/activated cellulose and coated well

Number of different measured assays onboard simultaneously 8 1–8 tests on 1–4 plates varies by assay, up to 288 allergens or 8 autoimmuneNumber of different assays programmed, calibrated at once 8 8 multipleNumber of user-definable (open) channels — — 3Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/— 8/48 varies by assay/up to 288 allergens or 8 autoimmune

Shortest/Median onboard reagent stability/Refrigerated onboard —/—/no —/—/no 8 hours/12 hours/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes minimal operator preparation, handling yesReagents barcoded/Information in barcode no/— no/— no/—Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/— yes/no yes/<1 part in 10,000Walkaway capacity in minutes/Specimens/Tests, assays ~240, assay dependent/192/8 180/92/8 assay dependent/100/288System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquid Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 100 µL 300 µL 10 µL, 110 µL with dead volumeMinimum sample volume aspirated precisely at once/Minimum dead volume 1 µL/100 µL 2 µL/200 µL 10 µL –50 µL, assay dependent/100 µLSupplied with UPS (backup power)/Requires floor drain no/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12, 13, 16 mm/no yes/12, 13, 16 mm/no yes/—/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/no yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/—Barcode placement per CLSI standard Auto2A no yes noOnboard test auto inventory (determines volume in container) no yes yesMeasures number of tests remaining/Short sample detection no/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen no yes yesClot detection/Reflex testing capability no/no yes/yes no/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

— no/no no/no

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte kit dependent 1–14 1–6Calibrants can be stored onboard/Average calibration frequency no/kit dependent no/check every month no/monthlyMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/yesHow often QC required kit dependent (shortest: every plate; longest: per batch) each run every assayOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no yes/no yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/5 minutes yes/yes/1–2 minutes yes/no/2–3 minutes

Stat time to completion of βhCG test — system is open, depends on reagent methodology —Time delay from ordering stat test to aspiration of sample — — —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

kit dependent/kit dependent dependent on reagent methodology/— —

Can autotransfer QC results to LIS/Onboard capability to review QC no/no yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface no/yes (included) onboard/no onboard/optionalLIS interfaces up and running in active user sites Harvest, LabDaq, MediTech 5.65, Sunquest, Data Innovations CHCS, Softmax, Sunquest, others yesLIS interface operates simultaneously with running assays no yes noBidirectional interface capability yes (host query) yes (host query and broadcast download) yesInterface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no yes/yes/yes yes/yes/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 48 hours within 24 hours within 48 hoursMean time between failures/To repair failures —/~2 hours — 7 months/4 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 30 minutes daily: 5–15 minutes daily: 10–15 minutes; weekly: 20–25 minutes;

monthly: 20–25 minutesOnboard maintenance records/Maintenance training demo module yes/no yes (includes audit trail)/yes yes (includes audit trail of who replaced parts)/yes

List price/Targeted bed size or daily volume —/380 tests per day $79,000/300+ $55,000/all sites, variable test volumesAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 2 days on site/yes yes/yes 3 days on site/yes



can process EIA + CLIA; aspirate 1 µL with less than 3% CV; no disposables or consumables

multibatch or continuous throughput EIA analyzer; user-defined menu, completely open system; easy color-coded worksheet and setup for operator; 2 probes for high-speed processing; unique cross-well washing; can use fixed probes or disposable tips

fully automated allergy and autoimmune testing; user-defined software channels for microtiter plate and tube-based assays




JUNE 2016 page 43

Part 12 of 21 Immunodiagnostic Systems (IDS) Inova Diagnostics Inova [email protected] Jackie Gonzalez-Rubio [email protected] Jackie Gonzalez-Rubio [email protected]


948 Clopper Rd., Gaithersburg, MD 20878 9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131877-852-6210 www.idsplc.com 858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com

Name of instrument/First year sold/Where designed IDS-iSYS/2009/France BIO-FLASH/2011/U.S. DS2/2006/U.S.Country where manufactured/Where reagents manufactured France/Belgium U.S./U.S. U.S./U.S., U.K.Number of units in clinical use in U.S./Outside U.S. >90/>500 — —Operational type/Model type/Sample handling system continuous random access/benchtop/rack sample loading continuous random access/benchtop/racks batch, with continuous load/benchtop/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 28 × 42 × 30/~6 21 × 34 × 24/5 30 × 17 × 26/3.07

Tests available on instrument in U.S. 1,25-dihydroxy vitamin D, 25 hydroxy vitamin D, insulin-like growth factor-I (IGF-I), human growth hormone (hGH), insulin-like growth factor binding protein-3 (IGFBP-3), CTX-I (CrossLaps), intact PTH, PTH (1-34) (for research use only), direct renin, aldosterone, 25 hydroxy vitamin DS

tTG IgA, tTG IgG, DGP screen, DGP IgA, DGP IgG, aCL IgG, aCL IgM, aCL IgA, B2GP1 IgG, B2GP1 IgM, B2GP1 IgA, MPO, PR3, GBM, ENA 7, RNP, Sm, centromere, SS-B, Jo-1, Ro52, Ro60, B2GP1 domain 1, dsDNA, CCP3

autoimmune, infectious disease

Tests not available in U.S. but submitted for clearance intact PINP, ostase BAP, N-MID osteocalcin — —

Tests not available in U.S. but available in other countries 1,25 VitDXp, intact PINP, N-MID osteocalcin, ostase BAP, TRAcP5b, salivary cortisol, 17-OH progesterone

CTD screen plus, Scl-70, DFS70 ELISA

Tests in development ACTH, cortisol, inaKtif MGP, total testosterone, 17-beta estradiol, free testosterone

— —

Tests not available on other manufacturers’ analyzers TRAcP5b, free testosterone, inaKtif MGP, 17-OH progesterone CCP3, domain 1, DFS70 —

Fully automated microplate system no no yesNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — minimum strip 1 × 8; maximum full plate: 96 wells × plates

Methods supported/Separation methods chemiluminescent and spectrophotometric/ magnetic particle

chemiluminescence/magnetic particle, bead enzyme immunoassay/coated microwell

Number of different measured assays onboard simultaneously 15 20 12 assays per plateNumber of different assays programmed, calibrated at once 15 — unlimitedNumber of user-definable (open) channels 0 0 unlimitedNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

15/100 20/50 and 100 test kits 8/96

Shortest/Median onboard reagent stability/Refrigerated onboard 7 days/56 days/yes (12°–15°C) varies by analyte/varies by analyte/yes (6°–8°C) 24 hours/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/lot, key information yes/type, number of tests, lot number, expiration date, master

calibration curveyes/yes

Same capabilities when 3rd-party reagents used/Susceptibility to carryover no/no no/— —/zero with disposable tipsWalkaway capacity in minutes/Specimens/Tests, assays assay dependent/120/15 —/30/20 assay dependent/98/assay dependentSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/up to 1,120 yes/280 no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 6 µL (assay dependent) 10 µL 200 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 4 µL/80 µL 10 µL/50 µL 5 µL/200 µL (50 µL with microtubes)Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/—Requires dedicated water system/Water consumption no/— no/— no/—Noise generated — — —Has dedicated pediatric sample cup/Dead volume yes/80 µL yes/50 µL yes/50 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/all up to 16 × 100 mm/no yes/12–16 mm/no yes/—/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/yes no/no

Time between initial result and reaspiration of sample for rerun dependent on run cycle or immediately after first result 30 minutes —Autocalibration or autocalibration alert yes yes noNumber of calibrators required for each analyte 2 2 variesCalibrants can be stored onboard/Average calibration frequency no/3–21 days no/lot change or failure of controls yes/each assayMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/noHow often QC required daily daily each assayOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/noAutomatic shutdown/Startup is programmable/Startup time yes/yes/<10 minutes yes/yes/<10 minutes no/yes/1–2 minutes

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample — less than 5 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

>26/>80 (every 45 seconds) 20/60 (30 minutes) assay dependent/—

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes —/yesData-management capability/Instrument vendor supplies LIS interface onboard/no (additional cost) onboard/yes (included) onboard/yes (additional cost)LIS interfaces up and running in active user sites yes — —LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download) yes (broadcast download and host query) yes (host query)Interface available (or will be) to auto specimen handling system no yes noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes yes/yes/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 24–48 hours 24 hours —Mean time between failures/To repair failures >200 days/<24 hours — —/<24 hoursAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 10 minutes;

monthly: 10 minutesweekly: 5 minutes; monthly: 15 minutes daily: 5 minutes

Onboard maintenance records/Maintenance training demo module yes (includes audit trail)/no yes/no yes/no

List price/Targeted bed size or daily volume —/all bed sizes, all volumes —/100–500 —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3 days on site/yes yes/yes 8 days on site/yes



full walkaway automation; compact benchtop design; continu-ous loading with batch, random, and stat flexibility; auto startup and shut down; onboard refrigeration of ready-to-use reagent cartridges; total traceability and full data transmitted to the LIS (results, QC, lot reagents and consumables, mes-sages, operator ID, washer used, and more); intelligent clot management (iCM) prevents measurement interruption and enhances productivity via maximized up time

random access, continuous load, chemiluminescent; benchtop footprint completing up to 450 results per shift; onboard reagents with stable calibration curves to eliminate batching and improve turnaround time

graphic interface with drag-and-drop icons; large sample throughput, with 98 samples and continuous load feature; consumable status window shows location and volume requirements during loading




JUNE 2016 page 46

Part 13 of 21 Inova Diagnostics Inova Diagnostics Inova DiagnosticsJackie Gonzalez-Rubio [email protected] Ed Bass [email protected] Ed Bass [email protected]


9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131 9900 Old Grove Rd., San Diego, CA 92131858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com 858-586-9900 www.inovadx.com

Name of instrument/First year sold/Where designed DSX/2000/Guernsey, U.K. QUANTA-Lyser 240/2008/Switzerland, Italy QUANTA-Lyser 2/2008/—Country where manufactured/Where reagents manufactured U.S./U.K. Switzerland/U.S. Switzerland/U.S.Number of units in clinical use in U.S./Outside U.S. 300/>500 135/171 5/72Operational type/Model type/Sample handling system batch/benchtop/rack batch/benchtop/racks batch/benchtop/racksDimensions in inches (H × W × D)/Instrument footprint in sq. feet 32 × 42 × 36/7 36 × 47 × 32/10.5 29.5 × 25.6 × 27.6/—

Tests available on instrument in U.S. autoimmune, infectious disease open system: autoimmune, infectious disease open system: autoimmune, infectious disease


Tests not available in U.S. but available in other countries any ELISA — —

Tests in development — — —

Tests not available on other manufacturers’ analyzers — — —

Fully automated microplate system yes yes yesNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate minimum strip: 1 × 8; maximum full plate: 96 × 4 plates 96 96

Methods supported/Separation methods enzyme immunoassay/coated microwell enzyme immunoassay/coated microwell, IFA slides enzyme immunoassay, IFA slides/coated microwell

Number of different measured assays onboard simultaneously 12 assays per plate 12–22 7Number of different assays programmed, calibrated at once unlimited — —Number of user-definable (open) channels unlimited open system open systemNumber of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/96 per 4 plates enzyme immunoassay/IFA enzyme immunoassay/IFA

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/—/no —/—/no —/—/noMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use requires operator prehandling, preparation requires prehandling requires prehandlingReagents barcoded/Information in barcode yes/yes — yes/—

Same capabilities when 3rd-party reagents used/Susceptibility to carryover yes/zero —/<10 no/<10-6

Walkaway capacity in minutes/Specimens/Tests, assays assay dependent/92/assay dependent assay dependent/up to 240/9 quantitative, 21 qualitative —/—/64 IFA, 96 enzyme immunoassay

System is open (homebrew methods can be used)/Liquid or dry system yes/liquid yes/liquid yes/liquid

Uses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 200 µL 200 µL 100 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 5 µL/200 µL (50 µL with microtubes) 5 µL/200 µL 5 µL/150 µL

Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/— no/— no/—


Has dedicated pediatric sample cup/Dead volume yes/50 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/various/no yes/10–16 mm/no yes/10–16 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes — —Onboard test auto inventory (determines volume in container) no no noMeasures number of tests remaining/Short sample detection no/yes no/yes no/yesAutomatic detection of adequate reagent or specimen yes no —

Clot detection/Reflex testing capability yes/no yes/no yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no — no/noDilution of patient samples onboard/Automatic rerun capability yes/no yes/no yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no — —

Time between initial result and reaspiration of sample for rerun — — —Autocalibration or autocalibration alert no no noNumber of calibrators required for each analyte assay specific assay dependent variesCalibrants can be stored onboard/Average calibration frequency yes/once per analyte per plate no/per run —/per runMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/no yes/no

How often QC required per plate per run per run

Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/no no/yes no/—Automatic shutdown/Startup is programmable/Startup time yes/—/1–2 minutes no/no/2 minutes no/no/2 minutes


assay dependent/— — —

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard/yes (additional cost) onboard/yes (additional cost)

LIS interfaces up and running in active user sites Cerner Classic and Millennium, Misys, SoftComp, Live Link, Triple G, FCC, ACA, LCW, LabLink

Cerner Classic and Millennium, Misys, SoftComp —

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (host query) yes (broadcast download, host query)Interface available (or will be) to auto specimen handling system no no noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/yes/yes no/no/no no/—/—

Can order (via modem) malfunctioning part(s) without operator no no —On-site response time of service engineer within 24 hours 24 hours 24 hoursMean time between failures/To repair failures —/<24 hours 8–9 months/less than 2 hours 6–8 months/—Average time to complete maintenance by lab personnel daily: 5 minutes daily: 5 minutes; weekly: 10 minutes

monthly: 10 minutesdaily: 5 minutes; weekly: 10 minutes; monthly: 10 minutes

Onboard maintenance records/Maintenance training demo module no/no no/— no/—

List price/Targeted bed size or daily volume —/200+ beds —/500 tests per day —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 8 days on site, 2 days at vendor offices/yes yes (2 days on site)/yes yes (2 days on site)/—



fully open, true four-plate system; modular design of reader, washer, incubators; barcode reader and ambient drawer enables easy upgrades and express shipping of replacement modules, reducing downtime; software can be configured for learned error recovery

fast processing time; low operating costs due to elimination of disposable tips; completely open high-throughput batch analyzer; reads IFA barcodes

processes IFA slides and ELISA assays simultaneously, LIS interface, large menu, and open-assay capability; reads IFA barcodes




JUNE 2016 page 47

Part 14 of 21 Inova Diagnostics Ortho Clinical Diagnostics Ortho Clinical DiagnosticsEd Bass [email protected] Mark Steelman [email protected] Mark Steelman [email protected]


9900 Old Grove Rd., San Diego, CA 92131 100 Indigo Creek Drive, Rochester, NY 14626 100 Indigo Creek Drive, Rochester, NY 14626858-586-9900 www.inovadx.com 585-453-3420 www.orthoclinical.com 585-453-3420 www.orthoclinical.com

Name of instrument/First year sold/Where designed QUANTA-Lyser 4000/2016/Switzerland VITROS ECi Immunodiagnostic System/1997/U.S. VITROS 3600 Immunodiagnostic System/2009/U.S.Country where manufactured/Where reagents manufactured Switzerland/Switzerland U.S./U.K. U.S./U.K.Number of units in clinical use in U.S./Outside U.S. — >500/>1,700 >150/>400Operational type/Model type/Sample handling system batch/benchtop/rack continuous random access/floor standing/universal sample

trays (circular) accommodate primary and secondary containers without need for adapters

continuous random access/floor standing/universal sample trays (circular) accommodate primary and secondary containers without need for adapters

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 36 × 60 × 30/15 51 × 44 × 29/8.9 68 × 83.5 × 34.9/20.2

Tests available on instrument in U.S. NOVA Lite IFA slides 3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG, estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimolar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, HBeAg, aHBe, vitamin D

3rd-gen. TSH, TT3, TT4, FT3, FT4, T3-uptake, total βhCG, estradiol, progesterone, LH, FSH, prolactin, NTx, CEA, AFP, CA 125 II, CA 15-3, ferritin, cortisol (serum and urine), CK-MB, troponin I, aHBs, B12, folate, RBC folate, equimolar PSA, HBsAg, aHCV, HBsAg (conf.), myoglobin, aHBc, aHBc IgM, aHBs, testosterone, NT-proBNP, CA 19-9, aHAV total, aHAV IgM, rubella IgG, aHIV 1+2, iPTH, vitamin D

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — toxo IgG, rubella IgM, toxo IgM, CMV IgG, CMV IgM, syphilis,

free PSA, total PSA IIaHBe, HBeAg, rubella IgM, toxo IgG, toxo IgM, CMV IgG, CMV IgM, syphilis, free PSA, total PSA II

Tests in development — C-peptide, HIV combo, insulin, syphilis, high sensitivity troponin C-peptide, HIV combo, insulin, NephroCheck, syphilis, high sensitivity troponin

Tests not available on other manufacturers’ analyzers — NTx NTx

Fully automated microplate system no no no

Number of each analyte performed in separate disposable unit — 1 1Number of wells in microplate — — —

Methods supported/Separation methods IFA slide processor/none (all assays homogeneous) chemiluminescence (enhanced)/individually coated microwell chemiluminescence (enhanced)/individually coated microwellNumber of different measured assays onboard simultaneously — 20 31Number of different assays programmed, calibrated at once — 20, up to 25 lots calibrated per assay 31, up to 25 lots calibrated per assayNumber of user-definable (open) channels — 0 —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

5/240 20/100 31/100

Shortest/Median onboard reagent stability/Refrigerated onboard 10 hours/1 day/no 56 days/56 days/yes (2° –8°C) 42 days/56 days/yes (2°–8°C)Multiple reagent configurations supported no yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/ID, lot, expiration date yes/test ID, expiration, lot number, pack ID yes/test ID, expiration date, lot number, pack IDSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero —/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 300/480/480 720/60/800 (with enhanced productivity module) varies/90/3,100System is open (homebrew methods can be used)/Liquid or dry system yes/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored — no/— no/—Uses washable cuvettes/Replacement frequency — no/— no/—Minimum specimen volume required 250 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 100 µL/200 µL 10 µL/80 µL 10 µL/35 µLSupplied with UPS (backup power)/Requires floor drain yes/— no, but it is available/no no, but it is available/noRequires dedicated water system/Water consumption no/— no/— no/—Noise generated — 60 decibels 60 decibelsHas dedicated pediatric sample cup/Dead volume yes/100 µL no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12–16 mm/no yes/multiple pediatric, microtainers, and cups, 5 mL,

7 mL, 10 mL on same universal sample tray/noyes/1.5 mL micro-collection containers; 0.5, 2.0 mL cups; 5, 7, 10 mL on same universal sample tray, no adapters/no

Sample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/— yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yes yes (2 of 5 interl., Codabar, codes 39 & 128 & ISBT 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) no yes yesMeasures number of tests remaining/Short sample detection no/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/no yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yesDilution of patient samples onboard/Automatic rerun capability yes/no yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun — assay dependent assay dependentAutocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte — 1–3 1–3 depending on assayCalibrants can be stored onboard/Average calibration frequency no/— no/28 days no/28 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/no yes/yes yes/yesHow often QC required each run once per 24 hours once per 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte no/no yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/15 minutes — —

Stat time to completion of βhCG test — 24 minutes 24 minutesTime delay from ordering stat test to aspiration of sample — immediate upon completion of last sample metering immediate upon completion of last sample meteringThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

— assay dependent/assay dependent (40 seconds) assay dependent/assay dependent (19 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface optional add-on/no onboard and optional add-on/no onboard and optional add-on/yes (additional cost)LIS interfaces up and running in active user sites — Cerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA,

Citation, DHCP, Unisys, McKesson, PathLab 3, Soft, othersCerner, Misys, Meditech, CHCS, Antrim, PathLab 2, RPNS VA, Citation, DHCP, Unisys, McKesson, PathLab 3, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (broadcast download) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system — no yes, enGenModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer — <4 hours (contract dependent) <4 hours (contract dependent)Mean time between failures/To repair failures — dependent on corrective action dependent on corrective actionAverage time to complete maintenance by lab personnel daily: 15 minutes; weekly: 30 minutes;

monthly: 30 minutesdaily: <5 minutes; weekly: <30 minutes; monthly: <10 minutes daily: 10 minutes; weekly: 25 minutes; monthly: 15 minutes

Onboard maintenance records/Maintenance training demo module — no/yes yes (includes audit trail)/yes

List price/Targeted bed size or daily volume — $109,000/various $220,000/various

Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes (2 days on site, 3 days at vendor offices)/yes yes/yes, as needed yes/yes, as needed



automated IFA slide barcode scanning; automated reagent bottle barcode scanning; pipettes mounting media onto IFA slides

uses Intellicheck technology to perform, monitor, document, and verify diagnostic checks throughout sample and assay processing to reduce potential of misreported results; Intel-liReport provides real-time status and traceability on quality of reported results; uses enhanced chemiluminescence, MicroWell technology

diagnostic checks throughout sample and assay processing reduces misreported results; real-time status and traceability on quality of reported results; fully automated, true random access stat testing for routine and specialty immunodiagnos-tic testing; single-use tips for sample and reagent metering; measures and flags results

JUNE 2016 page 48




Part 15 of 21 Randox Toxicology Roche Diagnostics Roche DiagnosticsDavid Ferguson [email protected] Ryan Dempsey [email protected] Brittany Greiner [email protected]


55 Diamond Rd., Crumlin, County Antrim, BT29 4QY 9115 Hague Rd., Indianapolis, IN 46250 9115 Hague Rd., Indianapolis, IN 462500044 28 9442 2413 www.randoxtoxicology.com 800-428-5074 us.diagnostics.roche.com 800-428-5074 us.diagnostics.roche.com

Name of instrument/First year sold/Where designed Evidence/2002/Northern Ireland cobas 8000 modular analyzer series/2010/Japan, Switzerland cobas e411 analyzer/2008/JapanCountry where manufactured/Where reagents manufactured Northern Ireland/Northern Ireland Japan/Germany Japan/GermanyNumber of units in clinical use in U.S./Outside U.S. 8/27 — —Operational type/Model type/Sample handling system batch/floor standing/carousel random access, continuous random access/floor standing/

rack-basedcontinuous random access/benchtop/rack, disk

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 68 × 78 × 39/22.75 52.8 × 58.8 × 45.6/— disk: 31.4 × 47.2 × 28.7/94; rack: 31.4 × 67 × 37.4/17.4Tests available on instrument in U.S. acetaminophen, amphetamine, barbiturates, bath salts (alpha

PVP, MDPV, methcathinone, mephedrone), benzodiazepine, benzlpiperazines, buprenorphine, cannabinoids, carbamazepine, chloral hydrate metabolite, cocaine metabolite, dextromethorphan, digoxin, dox series, EDDP, escitalopram, ethanol, ethyl glucuronide, fentanyl, flunitrazepam, fluoxetine, generic opiods, gentamicin, haloperidol, ibuprofen, ketamine, lithium, LSD, MDMA, meperidine, meprobamate, mescaline, methadone, methamphetamine, methaqualone, methylphenidate, mitragynine (kratom), NBOMe, nor buprenorphine, nor fentanyl, opiates, oxycodone, phencyclidine, phenobarbital, phenylpiperazines, phenytoin, propoxyphene, ritalinic acid, salicylate, salvinorin, sertraline, synthetic cannabinoids, more

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, anti-HBc, anti-HBc IgM, CMV IgM, vitamin D, CMV IgG, toxo IgM, toxo IgG, others

ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-crosslaps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, proges-terone, prolactin, PTH, PTH stat, rubella IgG, rubella IgM, SHBG, T3, T4, testosterone, total PSA, toxo IgG, troponin I, troponin T, anti-HBc, CMV IgM, vitamin D, CMV IgG, toxo IgM, others

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries — free βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV

Ag confirmatory test, HIV combi, othersfree βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV Ag confirmatory test, HIV combi, toxo IgM, CMV IgG, others

Tests in development — tacrolimus, sirolimus, cyclosporine, troponin T fifth generation; PCT, Interleukin 6, syphilis, others

tacrolimus, sirolimus, cyclosporine, troponin T fifth generation; PCT, Interleukin 6, syphilis, others

Tests not available on other manufacturers’ analyzers bath salts (alpha PVP, MDPV, methcathinone, mephedrone), dox series, mitragynine (kratom), NBOMe, synthetic cannabinoids (JWH-018/AM-2201, JWH-250/RCS-8, UR144 / XLR11, AKB48, AB PINACA)

9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more

Fully automated microplate system — no noNumber of each analyte performed in separate disposable unit — — —Number of wells in microplate — — —Methods supported/Separation methods chemiluminescence/— electrochemiluminescence/magnetic particle electrochemiluminescence/magnetic particleNumber of different measured assays onboard simultaneously 22 25 per module, maximum of 60 18Number of different assays programmed, calibrated at once 22 25 per module 18Number of user-definable (open) channels 0 — 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

44/360 25/100–200 tests per kit 18/100–200 tests per kit

Shortest/Median onboard reagent stability/Refrigerated onboard assay dependent/up to expiration/yes (2°–8ºC) 2 weeks/6 weeks/yes (20°C) 14 days/56 days/yesMultiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/product component, size, lot number, expiration date yes/calibration curve, application parameters,

lot number, expiration, reagent nameyes/calibration curve, application parameters, lot number, expiration, reagent name

Same capabilities when 3rd-party reagents used/Susceptibility to carryover — —/zero (uses disposable sample tips) no/zero (uses disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 100/180/540–1,080 360/300/5,000 disk: 120/30/180; rack: 120/100/180System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— yes/1,006 per module yes/360 assay tips; 180 assay cupsUses washable cuvettes/Replacement frequency no/— no/— no/—Minimum specimen volume required 7 µL 10 µL 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 7 µL/350 µL (varies with cup type) 10 µL/100 µL 10 µL/100 µLSupplied with UPS (backup power)/Requires floor drain optional/yes yes/yes yes/noRequires dedicated water system/Water consumption no/— yes/average 12 L per hour in full operation no/3 L for 250 testsNoise generated <60 decibels <65 decibels <70 decibelsHas dedicated pediatric sample cup/Dead volume no/— yes/100 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/12 mm, 16 mm/no yes/13 × 75, 16 × 100, false bottom/no yes/13–16 mm diameter/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability no/yes yes/yes (data manager) yes/yes (with middleware)Hemolysis detection-quantitation/Turbidity detection-quantitation no/no yes/yes, semiquantitative with integrated system no/noDilution of patient samples onboard/Automatic rerun capability no/no yes/yes yes/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no yes/yes

Time between initial result and reaspiration of sample for rerun assay dependent — —Autocalibration or autocalibration alert no yes yesNumber of calibrators required for each analyte 9 (multianalyte calibrators) 2 2Calibrants can be stored onboard/Average calibration frequency no/dependent on panel no/28 days no/monthly for lot, weekly for rackMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required each worklist 24 hours once per dayOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/13 minutes yes/yes/11 minutes yes/no/4 minutesStat time to completion of βhCG test — 9 min. incubation for hCG and 18 min. incubation for βhCG 9 minutesTime delay from ordering stat test to aspiration of sample — <1 minute 42 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

assay dependent/assay dependent (5 minutes) 56/176 (21 seconds) 30/86 (42 seconds)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (included in price) onboard/— onboard/yes (additional cost)LIS interfaces up and running in active user sites yes all major LISs —

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no yes (cobas 8100 system, task-targeted automation) yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours (contract dependent) <24 hours <24 hoursMean time between failures/To repair failures — 222 days (cobas e602 module)/varies 237 days (cobas e411 module)/variesAverage time to complete maintenance by lab personnel daily: 5 minutes; weekly: 10 minutes; monthly: 30 minutes 4–5 minutes hands-on daily maintenance daily: 5 minutes; weekly: 6 minutes; monthly: 10–15 min.Onboard maintenance records/Maintenance training demo module no/— yes (includes audit trail)/yes (online help) no/no List price/Targeted bed size or daily volume contract dependent/various —/large to very large —/varies, primary immunoassay system or backup unitAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training yes/yes 5 days at company offices/yes 4 days on site/yesDistinguishing features (supplied by company)


biochip enables simultaneous analysis of multiple analytes in single sample; maximum throughput of 1,188 tests per hour; unreported tests retrieved retrospectively; arrays contain multiple tests applicable to forensic toxicology and workplace drug testing

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents compatible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform; connects with cobas 8100 automated workflow series

ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents fully compatible with other Elecsys systems; range of stat assays with 9-minute assay time




JUNE 2016 page 50

Part 16 of 21 Roche Diagnostics Siemens Healthineers Siemens HealthineersRyan Dempsey [email protected] Joseph Amodeo [email protected] Tiia Maxwell [email protected]


9115 Hague Rd., Indianapolis, IN 46250 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 800-428-5074 us.diagnostics.roche.com 847-267-5393 www.usa.siemens.com/diagnostics 847-267-5393 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed cobas 6000 analyzer series/2006/Japan, Switzerland Dimension EXL 200/2011/U.S. Dimension Vista 500 Intelligent Lab System/2009/U.S.Country where manufactured/Where reagents manufactured Japan/Germany U.S./U.S. U.S./U.S., GermanyNumber of units in clinical use in U.S./Outside U.S. — >1,900 worldwide >1,000 worldwideOperational type/Model type/Sample handling system continuous random access/floor standing/rack batch, random access/floor standing/segmented sample

wheelcontinuous random access/floor standing/rack and aliquot plate system, batch

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 46.1 × 71.8 × 40/19.73 61 × 56 × 41/16 56 × 85 × 44/26

Tests available on instrument in U.S. ACTH, AFP, anti-CCP, anti-HAV IgM, anti-HAV total, anti-HBc IgM, anti-HBs, anti-HCV, anti-Tg, anti-TPO, anti-TSHR, beta-cross-laps, C-peptide, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, CK-MB stat, cortisol, DHEA-S, digoxin, estradiol, ferritin, folate, folate RBC, free PSA, FSH, FT3, FT4, HBsAg, HBsAg confirmatory, HCG II stat, HCG+ beta, HE4, hGH, HSV-1 IgG, HSV-2 IgG, IgE, insulin, LH, myoglobin, myoglobin stat, N-MID osteocalcin, proBNP, proBNP stat, progesterone, prolactin, PTH, PTH stat, rubella IgG, anti-HBc, CMV IgM, vitamin D, toxo IgM, toxo IgG, others

>100 (includes vendor-supported applications), tacrolimus, MPA, LOCI sensitive troponin I, LOCI NT-proBNP, LOCI TSH, LOCI free T4, LOCI free T3, sirolimus, total PSA, free PSA, CardioPhase hsCRP, ferritin, HCG, LV HCG, mass CK-MB, LV mass CK-MB, myoglobin, ammonia, urine/CSF protein, lactic acid, microalbumin, prealbumin, carbamazepine, cyclosporine, cyclosporine extended range, digoxin, digitoxin, gentamicin, lidocaine, lithium, N-acetylprocainamide, LOCI folate, LOCI B12, many others

>130 (includes vendor-supported applications), 35 general chemistry, 14 TDMs, 17 DATs, 3 anemia, 40 plasma proteins, 20 immunoassays, including sensitive troponin I, NT-proBNP, cyclosporine, LH, FSH, prolactin, CA 19-9, CA 125, CA 15-3, progesterone

Tests not available in U.S. but submitted for clearance — — testosteroneTests not available in U.S. but available in other countries free βhCG, PAPP-A, PTH (1-84), HBeAg, anti-HBe, HIV Ag, HIV

Ag confirmatory test, HIV combi, others>35 >20 (including vendor-supported applications)

Tests in development tacrolimus, sirolimus, cyclosporine, troponin T fifth generation; PCT, Interleukin 6, syphilis, others

vitamin D, high sensitive troponin I high sensitive troponin I

Tests not available on other manufacturers’ analyzers 9-min. TnT, 9-min. PTH, HSV-1, HSV-2, beta-crosslaps, more — LOCI immunoassay, nephelometric assays, gen. chemistry


Methods supported/Separation methods electrochemiluminescence/magnetic particle photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

Number of different measured assays onboard simultaneously 25 per module, maximum of 60 47 144Number of different assays programmed, calibrated at once 25 per module 47 144Number of user-definable (open) channels — 10 10Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

25/100–200 tests per kit 47/15–360 144/20–1,200

Shortest/Median onboard reagent stability/Refrigerated onboard 2 weeks/6 weeks/yes (20°C) 24 hours/30 days/yes (2°–8°C) 24 hours/30 days/yes (2°–8°C)Multiple reagent configurations supported yes yes noReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/calibration curve, application parameters,

lot number, expiration, reagent nameyes/lot number, unique flex ID, stability, expiration date yes/test method, lot number, expiration date, number of tests

Same capabilities when 3rd-party reagents used/Susceptibility to carryover —/zero (uses disposable sample tips) yes/none (due to probe washing) yes/<1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 360/150/5,000 can be hours/60/>2,000 >45/150/178,800System is open (homebrew methods can be used)/Liquid or dry system no/liquid yes/liquid (reconstitutes onboard, no reagent prep required) yes/liquidUses disposable cuvettes/Maximum number stored yes/1,006 per module yes/12,000 yes/>2,000Uses washable cuvettes/Replacement frequency no/— no/— yes/automatic as neededMinimum specimen volume required 10 µL 2 µL 2 µL analytical, 50 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL 2 µL/— 2 µL (GLU 1.2 µL)/10 µLSupplied with UPS (backup power)/Requires floor drain yes/yes yes/no yes/yesRequires dedicated water system/Water consumption yes/average 12 L per hour in full operation yes/5 L no/20 L per hourNoise generated <65 decibels <75 decibels <64 decibelsHas dedicated pediatric sample cup/Dead volume yes/100 µL yes/30 µL yes/10 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 16 × 100, false bottom/no yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes, on sample transport, shortly before sample is aspirated (2

of 5 interleaved, Codabar, codes 39 and 128)/yesyes, on sample transport, shortly before sample is aspirated (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Barcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes (with Roche Middleware Solutions) yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes, semiquantitative with integrated system yes/yes yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no yes/no can decrease/no

Time between initial result and reaspiration of sample for rerun — <20 seconds <2 minutesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 2 varies (3 levels for most assays) 2–6 (varies)Calibrants can be stored onboard/Average calibration frequency no/every 28 days yes (NA, K, Cl)/most 90 days yes/30–90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours 24 hours or with lot change once per 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/11 minutes no/no/8 minutes no/no/always ready

Stat time to completion of βhCG test 9 min. incubation for hCG and 18 min. incubation for βhCG 16 minutes 10 minutesTime delay from ordering stat test to aspiration of sample <1 minute <24 seconds <2 minutesThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

56/176 (21 seconds) up to 146/437 (7.2 seconds) >150/450 for immunoassay methods

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (additional cost) onboard, optional add-on/yes (additional cost) onboard/noLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes (cobas 8100 system, task-targeted automation) yes, Siemens VersaCell, Streamlab, Aptio Automation yes, Siemens, Streamlab, Advia LabCell, Advia WorkCell, Aptio

AutomationModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/no yes/yes/yes yes/yes/yes

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer ≤24 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures 259 days (cobas e601 module)/varies — —Average time to complete maintenance by lab personnel 3–5 minutes of hands-on daily maintenance daily: <5 minutes; weekly: 10 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 10 minutesOnboard maintenance records/Maintenance training demo module yes (includes audit trail)/yes (online help) no/no yes/yes

List price/Targeted bed size or daily volume — — —Annual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 5 days at company offices/yes 3 days at company offices/yes 4 days at company offices/yes



ECL technology-based assays provide wide measuring ranges and excellent low-end sensitivity (for example, troponin T); ready-to-use and barcoded reagents compatible with other Elecsys systems; range of stat assays with 9-minute assay time, integral part of c8000 platform; connects with cobas 8100 automated workflow series

integrates general chemistry with homogeneous LOCI and heterogeneous immunoassays onboard; allows a single platform for more than 95% of most requested tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays, QCC PowerPak onboard; reagent management system standard

ultra-integrated chemistry platform with LOCI advanced chemi-luminescence and nephelometry onboard; enhanced workflow efficiency with automated features, such as autocalibration, auto QC, and system twinning; proactive service and support through RealTime Solution Siemens Remote Service




JUNE 2016 page 51

Part 17 of 21 Siemens Healthineers Siemens Healthineers Siemens HealthineersJohn Dabney [email protected] John Dabney [email protected] Tiia Maxwell [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 877-229-3711 www.usa.siemens.com/diagnostics 877-229-3711 www.usa.siemens.com/diagnostics 847-267-5393 www.usa.siemens.com/diagnostics

Name of instrument/First year sold/Where designed ADVIA Centaur CP Immunoassay System/2005/U.S. ADVIA Centaur XPT Immunoassay System/2014/U.S. Dimension Vista 1500 Intelligent Lab System/2006/U.S.Country where manufactured/Where reagents manufactured Switzerland/U.S. Ireland/U.S. U.S./U.S., GermanyNumber of units in clinical use in U.S./Outside U.S. >557/>2,801 <10/>400 >1,000 worldwideOperational type/Model type/Sample handling system continuous random access/benchtop/7 × 12 position racks random access/floor standing/rack batch, random access, continuous random access/

floor standing/sample rack and aliquot plate systemDimensions in inches (H × W × D)/Instrument footprint in sq. feet 32 × 43 × 29/8.7 66 × 77 × 41/21.92 56 × 85 × 44/26

Tests available on instrument in U.S. total IgE, ferritin, folate, RBC folate, vitamin B12, vitamin D total, BNP, CKMB, myoglobin, Tnl-ultraTM, C-peptide, insulin, eHIV 1/O/2, HAV IgM, HAV total, HBc IgM, HBc total, HBsAg, HBsAg confirmatory, HCV, cyclosporine, cortisol, homocysteine, AFP, BR, CA 15-3, CA 19-9, CA 125II, CEA, complexed PSA, PSA, serum HER2/neu, DHEAS, enhanced estradiol, FSH, total hCG, LH, progesterone, prolactin, SHBG, testosterone, rubella IgG, rubella IgM, syphilis, anti-HBs2, others

allergy, anemia/iron metabolism, bone metabolism, cardiac, diabetes, infectious disease, immunosuppressant drugs, metabolic, oncology, reproductive endocrinology, special ID, therapeutic drug monitoring (TDM), thyroid, ToRCH

>130 (includes vendor-supported applications)

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries procalcitonin, HA, TIMP, PIIINP (ELF markers) — >20Tests in development vitamin D, D-dimer, galectin-3, anti-HBe, HBeAg, HIV combo

(CHIV), tacrolimus, free PSA, PIGF, sFLT-1, CMV IgG, CMV IgMmultiple testosterone, additional hormones

Tests not available on other manufacturers’ analyzers complexed PSA, serum HER2/neu — LOCI technology, nephelometry, general chemistry


Methods supported/Separation methods chemiluminescence/magnetic particle acridinium ester, chemiluminescence/magnetic particle photometry, potentiometry (ISE), turbidimetric, nephelometry and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

Number of different measured assays onboard simultaneously 15 30 166Number of different assays programmed, calibrated at once >84 assays and multiple calibration lots 300 166Number of user-definable (open) channels — — 10Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

15/50–200 30/50, 100, 200 tests per pack 166/20–1,200

Shortest/Median onboard reagent stability/Refrigerated onboard 4 days/28 days/yes (4°C) 4 days/28 days/yes (4°C) 24 hours/30 days/yes (2°–8°C)Multiple reagent configurations supported yes yes noReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/reagent ID, lot number, expiration date yes/assay name, lot No., expir. date, pack ID, No. of tests yes/test ID, lot No., individual sequence number, exp. dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero —/zero yes/<1 ppmWalkaway capacity in minutes/Specimens/Tests, assays 210/72/480 280/180/840 >45/150/205,200System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid yes/liquidUses disposable cuvettes/Maximum number stored yes/400 yes/1,000 yes/>2,000Uses washable cuvettes/Replacement frequency no/— no/— yes/as neededMinimum specimen volume required 10 µL, assay dependent 10 µL, assay dependent 2 µL analytical, 50 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/50 µL 10 µL/50 µL 20 µL (GLU=1.2 µL)/10 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption no/none no/2.5 L per hour no/20 L per hourNoise generated <60 decibels <62 decibels 64 decibelsHas dedicated pediatric sample cup/Dead volume no (uses microtainers)/50 µL no/— yes/10 µLPrimary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-, 10-, 1-mL cups, microtainer tubes/no yes/1-, 2-, 3-, 5-, 7-, 10-mL, microtainer tubes/no yes/10 × 50, 10 × 65, 13 × 65, 13 × 75, 13 × 100, 15 × 92,

16 × 100, 13 × 90/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes, on sample transport, shortly before sample is aspirated (2

of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A yes yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no yes/yesDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no (has autodilution)/no (has autodilution) no/no no/no (has autodilution)

Time between initial result and reaspiration of sample for rerun varies 15 seconds <2 minutesAutocalibration or autocalibration alert yes yes yes Number of calibrators required for each analyte 2 2 2–6 (varies)Calibrants can be stored onboard/Average calibration frequency no/28 days (assay dependent) no/28 days (assay dependent) yes/30–90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required user defined user defined shortest interval: 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes no/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/always ready/<5 minutes no/no/always ready no/no/always ready

Stat time to completion of βhCG test 15 minutes 18 minutes 10 minutesTime delay from ordering stat test to aspiration of sample 20 seconds 15 seconds <2 minutesThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

60/180 (20 seconds) 80/240 (15 seconds) >150/450 for immunoassay methods

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes no/yes yes/yesData-management capability/Instrument vendor supplies LIS interface yes/yes onboard/yes onboard/noLIS interfaces up and running in active user sites all major LIS vendors all major LIS vendors all major LIS vendorsLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system no yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab, Aptio yes, Siemens VersaCell, Streamlab, Advia LabCell, Advia

WorkCell, Aptio AutomationModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours 2–8 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 15 minutes; weekly: 20 minutes; monthly: 30 minutes daily: 5 minutes; weekly: 5 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 10 minutes; monthly: 10 minutesOnboard maintenance records/Maintenance training demo module yes/yes yes/yes yes/yes

List price/Targeted bed size or daily volume —/200+ beds or 250 tests per day —/300+ beds or 500 tests per day —Annual service contract cost (24 hours/7 days) — multiple options —Training provided with purchase/Advanced operator training 4 days at company offices/yes 4.5 days on site/yes 4 days at company offices/yes



automates routine operations, including ability to access/change solutions, waste, disposables, and reagents without pausing sampling or processing; onboard automatic dilutions, repeats, stats, and cascade reflex testing; disposable tips; uses same reagents/consumables as Advia Centaur/Advia Centaur XP with concordant results; throughput 180 tests per hour; average time to first result ~15 minutes

on-the-fly loading/unloading of samples, reagents, and supplies; 2-D barcode scanner uploads test definitions; automated daily maintenance, no monthly cleaning procedures; no daily startup procedure; up to 240 tests per hour; stat port allows priority sampling at any time; disposable sample tips; automated clot management; SMART algorithm software automates repeat and confirmatory testing of reactive samples; direct connectivity to Siemens Automation Solutions, CentraLink Data Management System, and Siemens Remote Service (SRS)

intelligent lab system with customer-driven design, ultra-integration of technologies; LOCI advanced chemiluminescence and automation onboard for efficiency, simplicity, sensitivity, and convenience to provide an efficient workflow for the laboratory; autocalibration and auto QC onboard; proactive services and support through RealTime Solution Siemens Remote Service




JUNE 2016 page 54

Part 18 of 21 Siemens Healthineers Siemens Healthineers ThermoFisher ScientificJoseph Amodeo [email protected] John Dabney [email protected] Nicole Ramsey [email protected]


511 Benedict Ave., Tarrytown, NY 10591 511 Benedict Ave., Tarrytown, NY 10591 4169 Commercial Ave., Portage, MI 49002847-267-5393 www.usa.siemens.com/diagnostics 877-229-3711 www.usa.siemens.com/diagnostics 800-346-4364 www.thermofisher.com

Name of instrument/First year sold/Where designed Dimension EXL with LM Integrated Chemistry System/2009/U.S. IMMULITE 2000 XPi Immunoassay System/2009/U.S. Phadia Laboratory System 100/1995/SwedenCountry where manufactured/Where reagents manufactured U.S./U.S. U.S./Wales, U.K. Sweden/SwedenNumber of units in clinical use in U.S./Outside U.S. >1,800 worldwide >103/>1,283 —Operational type/Model type/Sample handling system batch, random access, continuous random access/

floor standing/racksrandom access/floor standing/rack batch/benchtop/carousel

Dimensions in inches (H × W × D)/Instrument footprint in sq. feet 49 × 82 × 41 (without monitor)/25.1 (with printer shelf down) 47 × 60 × 30/12.5 18 × 28 × 24 plus computer/—

Tests available on instrument in U.S. >100 (includes vendor-supported applications) 3gAllergy specific, total IgE, ferritin, folic acid, RBC folate, vitamin B12, calcitonin, PYRILINKS-D, high-sensitivity CRP, myoglobin, troponin I, CMV IgG, CMV IgM, herpes I & II IgG, toxo. quantitative IgG, toxo. IgM, rubella quantitative IgG, rubella IgM, C-peptide (serum, urine), insulin, microalbumin (urine) (ALB), growth hormone (hGH), IGF-I, IGFBP-3, anti-HBc IgM, anti-HBc total, anti-HBs, HBs Ag, HBs Ag confirmatory, H. pylori IgG, syphilis, ACTH, cortisol, anti-CCP, TSI, others

hundreds of ImmunoCAP-specific IgE allergens and allergen components, ImmunoCAP-total IgE and tryptase; EliA autoimmune products include anti-TG, anti-TPO, M2, CCP, dsDNA, Symphony ANA screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA, EliA PR3s, GBM, MPOs

Tests not available in U.S. but submitted for clearance — — —Tests not available in U.S. but available in other countries >35 (includes vendor-supported applications) AlaTOP allergy screen, allergen-specific IgG, allergen-specific IgG4,

ECP, osteocalcin, CK-MB, D-dimer, NT-proBNP, IL-2R, IL-6, IL8, LBP, free beta HCG, PAPP-A, EBV-EBNA IgG, EBV-VCA IgG, EBV-VCA IgM

EliA CTD screen (15 ENAs), Pm/Scl, EliA Anti IgA, EliA calpro-tectin, EliA ASCA IgG/IgA, EliA Rib-P and six other "rare" ENAs, RF IgG, and CCP IgA

Tests in development vitamin D, high sensitive troponin I — —Tests not available on other manufacturers’ analyzers — IGF-I, IGFBP-3, androstenedione, β2 microglobulin, gastrin,

canine TLI, canine total T4, canine TSH, 3gAllergy-specific IgEImmunoCAP-specific IgE blood tests and EliA autoimmune tests


Methods supported/Separation methods photometry, potentiometry (ISE), turbidimetric and EMIT/advanced LOCI chemiluminescence technology, PETINIA and ACMIA

chemiluminescence/bead, centrifugation fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

Number of different measured assays onboard simultaneously 91 24 4Number of different assays programmed, calibrated at once 91 unlimited 7 Number of user-definable (open) channels 10 — 0 (closed system)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

91/15–360 24/200 48–96, depending on the conjugate type/48

Shortest/Median onboard reagent stability/Refrigerated onboard 24 hours/30 days/yes (2°–8°C) 90 days/90 days/yes (4°C) —Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yes (wash solution requires preparation)Reagents barcoded/Information in barcode yes/lot number, unique flex ID, stability, expiration date yes/test, lot number, expiration date yes/product name, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover yes/none (due to probe washing) no/<3 ppm no/—Walkaway capacity in minutes/Specimens/Tests, assays can be hours/60/>2,000 300/90/1,300 180/varies with analyte/48System is open (homebrew methods can be used)/Liquid or dry system yes/liquid (reconstitutes onboard, no reagent prep required) no/liquid no/liquidUses disposable cuvettes/Maximum number stored yes/12,000 yes/1,300 no/—Uses washable cuvettes/Replacement frequency no/— no/— —Minimum specimen volume required 2 µL 5–100 µL 40 µL for ImmunoCAP tests and 20 µL for EliA testsMinimum sample volume aspirated precisely at once/Minimum dead volume 2 µL/primary tube capable 5 µL/50 µL ImmunoCAP: 40 µL/40–200 µL; EliA: 50 µL/20–200 µLSupplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/noRequires dedicated water system/Water consumption yes/up to 5 L no/— no/1 L per runNoise generated <75 decibels 52 decibels —Has dedicated pediatric sample cup/Dead volume yes/30 µL yes/50 µL no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/5-, 7-, 10-, 1.5-, and 1.0-mL sample cups/no yes/75–100 mm/no yes/10–16 mm × 50–105 mm/noSample barcode reading capability/Autodiscrimination yes, on sample transport, shortly before sample is aspirated (2

of 5 interleaved, Codabar, codes 39 and 128)/yesyes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes

Barcode placement per CLSI standard Auto2A yes yes noOnboard test auto inventory (determines volume in container) yes yes noMeasures number of tests remaining/Short sample detection yes/yes yes/yes no/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation yes/yes yes/yes no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no no (has autodilution)/no (has autodilution) no/no

Time between initial result and reaspiration of sample for rerun <20 seconds minimum 18 seconds 2.5 hours (batch run)Autocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte varies (3 levels for most assays) 2-level adjusters, supplied in kit 6 per analyte for calibration run, 2 when using stored curveCalibrants can be stored onboard/Average calibration frequency yes (NA, K, Cl)/most 90 days no/1–4 weeks (assay dependent) yes/28 days or sooner if conjugate lots changeMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required 24 hours or with lot change customer determined once per work shift (user defined)Onboard real-time QC/Support multiple QC lot Nos. per analyte no/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time no/no/not required yes/yes/4 minutes yes/yes/20 min. including request entry or downloading

Stat time to completion of βhCG test 16 minutes 35 minutes —Time delay from ordering stat test to aspiration of sample <24 seconds 18 seconds —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

up to 146/437 (7.2 seconds) 67/200 (18 seconds) batch analyzer/48 (180 minutes processing time for batch to finish)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard, optional add-on/yes (additional cost) yes/yes onboard/yes, instrument side only (included)LIS interfaces up and running in active user sites all major LIS vendors yes Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American

Health Net, Antrim, othersLIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes, Siemens VersaCell, Streamlab, Aptio Automation yes, Advia WorkCell, Advia LabCell, VersaCell, StreamLab yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer 2–8 hours 2–8 hours —Mean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: <5 minutes; weekly: 10 minutes; monthly: 10 minutes daily: 5–10 minutes; weekly: 20 minutes; monthly: 20–30

minutesdaily: 5 minutes; weekly: 10 minutes; monthly: 15 minutes

Onboard maintenance records/Maintenance training demo module no/yes no/yes yes/no

List price/Targeted bed size or daily volume — —/>200+ beds or 250 tests per day —/>7,000–20,000 tests per yearAnnual service contract cost (24 hours/7 days) multiple types multiple options —Training provided with purchase/Advanced operator training 4 days at company offices/no yes/yes 3.5 days at company offices/yes



integrates homogeneous LOCI and heterogeneous immunoassays onboard with other chemistries; allows single platform for >95% of most tests; eliminates sample splitting between general chemistry tests and immunoassays; fully automated onboard ISD assays; QCC PowerPak onboard; reagent management standard

extensive routine and specialty immunoassay menu (81 assays); includes menu of 300+ specific allergens and panels; provides opportunity to reduce sendouts and boost laboratory revenue; features extended reagent onboard stability (90 days) for efficient operation and cost control

provides accepted technology for serologic, specific IgE testing, and autoimmune markers; comprehensive clinical and technical research; extensive medical information and education; measures and reports specific IgE quantitative results across clinical range




JUNE 2016 page 55

Part 19 of 21 ThermoFisher Scientific ThermoFisher Scientific ThermoFisher ScientificNicole Ramsey [email protected] Nicole Ramsey [email protected] Nicole Ramsey [email protected]


4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002 4169 Commercial Ave., Portage, MI 49002800-346-4364 www.thermofisher.com 800-346-4364 www.thermofisher.com 800-346-4364 www.thermofisher.com

Name of instrument/First year sold/Where designed Phadia Laboratory System 250/2004/Japan, Sweden Phadia Laboratory System 1000/2003/Japan, Sweden Phadia Laboratory System 2500/2011/SwedenCountry where manufactured/Where reagents manufactured Japan, Sweden/Sweden Japan, Sweden/Sweden Japan/SwedenNumber of units in clinical use in U.S./Outside U.S. 203/2,019 127/308 5/28Operational type/Model type/Sample handling system continuous random access/floor standing/racks continuous random access/floor standing/racks continuous random access/floor standing/racksDimensions in inches (H × W × D)/Instrument footprint in sq. feet 73 × 50 × 30 plus 26-in. wide computer stand/— 83 × 71 × 40 plus 26-in. wide computer stand/— 71 × 158 × 47 plus 26-in. wide computer stand/51

Tests available on instrument in U.S. hundreds of ImmunoCAP-specific IgE allergens and allergen components, ImmunoCAP-total IgE and tryptase; EliA autoimmune products include anti-TG, anti-TPO, M2, CCP, dsDNA, Symphony ANA Screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA, M2, EliA PR3s, GBM, MPOs

hundreds of ImmunoCAP-specific IgE allergens and allergen components, ImmunoCAP-total IgE and tryptase

hundreds of ImmunoCAP-specific IgE allergens and allergen components and ImmunoCAP-total IgE; EliA autoimmune products include M2, anti-TG, anti-TPO, and CCP

Tests not available in U.S. but submitted for clearance EliA anti-TPO, EliA anti-TG — EliA PR3s, GBM, MPOs, tryptase, dsDNA, Symphony ANA screen, 7 individual ENAs, Celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA

Tests not available in U.S. but available in other countries EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

— EliA CTD screen (15 ENAs), Pm/Scl, EliA anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

Tests in development — — —Tests not available on other manufacturers’ analyzers ImmunoCAP-specific IgE blood tests and EliA

autoimmune testsImmunoCAP-specific IgE blood tests ImmunoCAP-specific IgE blood tests and EliA autoimmune

assays


Methods supported/Separation methods fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

fluoroenzyme immunoassay/ImmunoCAP cellulose polymer matrix reaction wells

Number of different measured assays onboard simultaneously 6 3 up to 8Number of different assays programmed, calibrated at once not limited, though inventory manager software will instruct

operator of reagent insufficiencies in the onboard inventorynot limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

not limited, though inventory manager software will instruct operator of reagent insufficiencies in the onboard inventory

Number of user-definable (open) channels 0 (closed system) 0 (closed system) 0 (closed system)Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

3/400 or 100, depending on the conjugate type 3/400 or 100, depending on the conjugate type 8/400, 100, or 50, depending on the conjugate type

Shortest/Median onboard reagent stability/Refrigerated onboard 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C) 5 days/1 year/yes (2°–8°C)Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes (wash solution requires preparation) yes (wash solution requires preparation) yesReagents barcoded/Information in barcode yes/product name, lot number, expiration date yes/product name, lot number, expiration date yes/product name, lot number, expiration dateSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/— no/zero (disposable sample tips) no/zero (disposable sample tips)Walkaway capacity in minutes/Specimens/Tests, assays 470/50 simultaneously/370 tests 460/200 simultaneously/2,400 tests 470/800 simultaneously (370 tests)/6,400 testsSystem is open (homebrew methods can be used)/Liquid or dry system no/liquid no/liquid no/liquidUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency — — —Minimum specimen volume required 40 µL for ImmunoCAP tests and 20 µL for EliA tests 40 µL per test 40 µL for ImmunoCAP tests and 20 µL for EliA testsMinimum sample volume aspirated precisely at once/Minimum dead volume 40–200 µL for ImmunoCAP tests and 50 µL/

50–200 µL for EliA tests (varies with tube type)40 µL/40–200 µL (varies with tube type) 40–200 µL for ImmunoCAP tests and 50 µL/

50–200 µL for EliA tests (varies with tube type)Supplied with UPS (backup power)/Requires floor drain yes/no yes/no yes/yesRequires dedicated water system/Water consumption no/10 L no/10 L yes/121 LNoise generated 65 decibels 68 decibels 64 decibelsHas dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/no yes/10–17 mm × 50–105 mm/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A no no noOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/yesHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes no/yes yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 100 minutes 100 minutes 100 minutesAutocalibration or autocalibration alert yes yes yesNumber of calibrators required for each analyte 6 per analyte for calibration run, 2 per analyte when using

stored curve6 per analyte for calibration run, 2 per analyte when using stored curve

5 or 6 per analyte for calibration run (assay dependent), 2 per analyte when using stored curve

Calibrants can be stored onboard/Average calibration frequency yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots change yes/28 days or sooner if conjugate lots changeMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per work shift (user defined) once per work shift (user defined) once per work shift (user defined)Onboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes yes/yesAutomatic shutdown/Startup is programmable/Startup time yes/yes/30 minutes unattended yes/yes/30 minutes unattended yes/yes/30 minutes unattended

Stat time to completion of βhCG test — — —Time delay from ordering stat test to aspiration of sample 6 minutes 6 minutes —Throughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

20 specimens/60 (100 minutes to first result, then 1 result per 60 seconds )

80 specimens/240 (100 minutes to first result, then 1 result per 15 seconds )

160 specimens/480 (100 minutes to first result, then 8 results per 15 seconds )

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/yesData-management capability/Instrument vendor supplies LIS interface onboard/yes (instrument side only) onboard/yes (instrument side only) onboard/—LIS interfaces up and running in active user sites Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, othersMisys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, others

Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem, American Health Net, Antrim, HL7, others

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system yes yes yesModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component


Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours <24 hours <24 hoursMean time between failures/To repair failures — — —Average time to complete maintenance by lab personnel daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 1 minute; weekly: 10 minutes; monthly: 15 minutesOnboard maintenance records/Maintenance training demo module yes/— yes/— yes/—

List price/Targeted bed size or daily volume —/>20,000–95,000 tests per year —/>95,000 tests per year —/>200,000 tests per yearAnnual service contract cost (24 hours/7 days) — — —Training provided with purchase/Advanced operator training 3.5 days at company offices/yes 4.5 days at laboratory/yes 4 days on site/yes



provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products and autoimmune markers with the EliA family of products; comprehensive clinical and technical research and extensive medical information and education

provides accepted technology for serologic, specific IgE testing with the ImmunoCAP family of products; comprehensive clinical and technical research and extensive medical information and education; measures and reports specific IgE quantitative results across the clinical range

continuous random access analyzer provides more than 6,000 tests in one run; high-throughput instrument optimized for cost-conscious laboratories; efficient and flexible to meet allergy and autoimmune assay testing needs

JUNE 2016 page 56




Part 20 of 21 ThermoFisher Scientific TOSOH Bioscience TOSOH BioscienceNicole Ramsey [email protected] Susan Kolarik [email protected] Susan Kolarik [email protected]


4169 Commercial Ave., Portage, MI 49002 6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080 6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080800-346-4364 www.thermofisher.com 800-248-6764 www.tosoh.com 800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed Phadia Laboratory System 5000/2011/Sweden AIA-2000/2008/Japan AIA-360/2004/JapanCountry where manufactured/Where reagents manufactured Japan/Sweden Japan/Japan Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 1/16 90/700 2,000/6,500Operational type/Model type/Sample handling system continuous random access/floor standing/racks continuous random access/floor standing/rack, sorter drawer continuous random access/benchtop/carouselDimensions in inches (H × W × D)/Instrument footprint in sq. feet 71 × 236 × 47 plus 26-inch wide computer stand/77 49.6 × 59.1 × 35.7/14.66 21 × 19 × 16/2.1

Tests available on instrument in U.S. hundreds of ImmunoCAP-specific IgE allergens and allergen components and ImmunoCAP-total IgE

TSH 3rd gen., TSH, FT4, FT3, T4, T3, T-uptake, TPOAb, TgAb, bHCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, beta 2 microglobulin, C-peptide, cortisol, hGH, IgEII, insulin, PAP, CK-MB, myoglobin, troponin I 2nd gen., ferritin, folate, B12, testosterone, CA 19-9, intact PTH, RBC folate, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D, HCG, SHBG, hsE2

10 minutes short-time assays: TSH, FT4, T3, T4, T-uptake, FT3, βhCG, estradiol, FSH, LH, progesterone, prolactin, AFP, CEA, PSA, CA 125, 27.29, β-2-microglobulin, C-peptide, cortisol, hGH, IgE II, insulin, PAP, CK-MB, myoglobin, troponin I second generation, ferritin, testosterone, CA 19-9, intact PTH, cystatin C, HbA1c, ACTH, DHEA-S, homocysteine, HCG, SHBG

Tests not available in U.S. but submitted for clearance EliA PR3s, GBM, MPOs, tryptase, EliA autoimmune products currently include CCP, dsDNA, symphony ANA screen, 7 individual ENAs, celikey (tissue transglutaminase) IgA/IgG, gliadin (deamidated and native) IgA/IgG, RF IgM/IgA, cardiolipin IgM/IgG/IgA, β2-glycoprotein IgM/IgG/IgA, EliA anti-TPO, EliA anti-TG

Tg Tg

Tests not available in U.S. but available in other countries EliA CTD screen (15 ENAs), Pm/Scl, EliA Anti IgA, EliA calprotectin, EliA ASCA IgG/IgA, EliA Rib-P and six other “rare” ENAs, RF IgG, and CCP IgA

BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, wPTH, D-dimer, osteocalcin, PIVKA

BNP, HBsAg, HBsAb, HBcAg, HBcAb, HBeAg, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, wPTH, PIVKA, D-dimer, osteocalcin

Tests in development — presepsin, scc presepsin, sccTests not available on other manufacturers’ analyzers ImmunoCAP-specific IgE blood tests and EliA autoimmune

assays— —


Methods supported/Separation methods fluorescence/coated microwell, fluoroenzyme immunoassay, ImmunoCAP cellulose polymer matrix reaction wells

fluorescence, enzyme immunoassay/bead fluorescence, enzyme immunoassay/bead

Number of different measured assays onboard simultaneously up to 8 48 25Number of different assays programmed, calibrated at once not limited, though inventory manager software will instruct

operator of reagent insufficiencies in the onboard inventory48 entire menu

Number of user-definable (open) channels 0 (closed system) 0 0Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

8/400, 100, or 50, depending on the conjugate type 48/unitized test cup —/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 5 days/1 year/yes (2°–8°C) 72 hours/72 hours/no 72 hours/72 hours/—Multiple reagent configurations supported yes yes yesReagent container placed directly on system for use yes yes yesReagents barcoded/Information in barcode yes/product name, lot number, expiration date yes/lot number, test code, serial number yes/lot number, test codeSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable sample tips) no/zero no/zeroWalkaway capacity in minutes/Specimens/Tests, assays 470/800 simultaneously (370 tests)/9,200 tests 172/200/960 58/25/25System is open (homebrew methods can be used)/Liquid or dry system no/liquid no/dry no/dryUses disposable cuvettes/Maximum number stored no/— no/— no/—Uses washable cuvettes/Replacement frequency — no/— no/—Minimum specimen volume required 40 µL for ImmunoCAP tests and 50 µL for EliA tests 500 µL tube, 100 µL cup 500 µL tube, 100 µL cupMinimum sample volume aspirated precisely at once/Minimum dead volume 40–200 µL for ImmunoCAP tests and 50 µL/50–200 µL for

EliA tests (varies with tube type)10 µL/500 µL tube, 100 µL cup 10 µL/500 µL tube, 100 µL cup

Supplied with UPS (backup power)/Requires floor drain yes/yes yes/no no/noRequires dedicated water system/Water consumption yes/215 L no/— no/—Noise generated 64 decibels — —Has dedicated pediatric sample cup/Dead volume no/— no/— no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/10–17 mm × 50–105 mm/no yes/7 mL and 10 mL or 15 × 75 and 100, 13 × 75 and 100/no yes/primary draw tubes: 13 × 75 and 100; 16 × 75 and 100/noSample barcode reading capability/Autodiscrimination yes (2 of 5 interleaved, Codabar, codes 39 and 128)/yes yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yes yes/yesBarcode placement per CLSI standard Auto2A no yes yesOnboard test auto inventory (determines volume in container) yes yes yesMeasures number of tests remaining/Short sample detection yes/yes yes/yes yes/yesAutomatic detection of adequate reagent or specimen yes yes yesClot detection/Reflex testing capability yes/yes yes/yes yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/no no/no no/noDilution of patient samples onboard/Automatic rerun capability yes/yes yes/yes no/noSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

no/no no/no no/no

Time between initial result and reaspiration of sample for rerun 100 minutes varies —Autocalibration or autocalibration alert yes no noNumber of calibrators required for each analyte 5 or 6 per analyte for calibration run (assay dependent), 2 per

analyte when using stored curve2 or 6 (analyte dependent) 2 or 6 (analyte dependent)

Calibrants can be stored onboard/Average calibration frequency yes/28 days or sooner if conjugate lots change no/90 days no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yes yes/yes yes/yesHow often QC required once per work shift (user defined) 24 hours 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte yes/yes yes/yes no/noAutomatic shutdown/Startup is programmable/Startup time yes/yes/30 minutes no/no/5 minutes no/no/5 minutes

Stat time to completion of βhCG test — ~18 minutes ~18 minutesTime delay from ordering stat test to aspiration of sample — 40 seconds 60 secondsThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

320 specimens/960 (100 minutes to first result, then 8 results per 15 seconds )

66/200 (18 seconds) 12/36 (1 minute)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/yes yes/yes yes/noData-management capability/Instrument vendor supplies LIS interface onboard/— —/no —/noLIS interfaces up and running in active user sites Misys, Cerner, SCC, Orchard, Antek, Triple-G, Tandem,

American Health Net, Antrim, HL7, others— —

LIS interface operates simultaneously with running assays yes yes yesBidirectional interface capability yes (broadcast download and host query) yes (broadcast download and host query) noInterface available (or will be) to auto specimen handling system yes yes (Hitachi, A&T, Bayer, Thermo, iLAS) noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

yes/yes/yes no/no/no no/no/no

Can order (via modem) malfunctioning part(s) without operator no no noOn-site response time of service engineer <24 hours 24 hours —Mean time between failures/To repair failures — 5 months/24 hours >6 months/24 hoursAverage time to complete maintenance by lab personnel daily: 1 minute; weekly: 10 minutes; monthly: 15 minutes daily: 5 minutes; weekly: 5 minutes daily: 5 minutesOnboard maintenance records/Maintenance training demo module yes/— yes (includes audit trail)/no no/no

List price/Targeted bed size or daily volume —/>400,000 tests per year $185,000/65+ beds, 1,500–2,000 tests $25,000/200–1,000 tests per monthAnnual service contract cost (24 hours/7 days) — — $2,050–$3,500Training provided with purchase/Advanced operator training —/yes 4 days at company office/no training DVD; on-site install/—



continuous random access analyzer provides more than 9,000 tests in 1 run; high throughput; efficient and flexible to meet allergy and autoimmune assay testing needs

available in 2 models: standard and LA; unitized test cups similar to all AIA systems; 3 separate incubators to minimize processing time; no reagent preparation; dual clot detection, automated sample dilution, and pretreatment; appropriate for stat and routine use

unitized test cups; primary tube sampling; no reagent preparation, room-temperature stability for 5 days; third-generation TSH sensitivity; second-generation troponin I; appropriate for stat and routine use; compact size; 4 tests per sample; random access

JUNE 2016 page 58


Part 21 of 21 TOSOH BioscienceSusan Kolarik [email protected]


6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed AIA-900/2011/JapanCountry where manufactured/Where reagents manufactured Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 320/1,300Operational type/Model type/Sample handling system continuous random access/floor standing/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 35.04, 50.79, or 58.64 × 26.18 × 49.09/6–10

Tests available on instrument in U.S. TSH, 3rd-gen. TSH, T4, TT3, TU, FT4, FT3, TPOAb, TgAb, BHCG, estradiol, FSH, LHII, progesterone, prolactin, testosterone, AFP, CEA, PSA, CA125, CA19-9, 27.29, β2 microglobulin, C-peptide, insulin, IgEII, PAP, cortisol, HGH, B12, folate, RBC folate, ferritin, intact PTH, CK-MB, myoglobin, cTnI second generation, HbA1c, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D, SHBG, HCG, hsE2

Tests not available in U.S. but submitted for clearance Tg

Tests not available in U.S. but available in other countries BNP, HBsAg, HBsAb, HBcAb, HBeAb, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, D-dimer, wPTH, osteocalcin, PIVKA

Tests in development presepsin, sccTests not available on other manufacturers’ analyzers —

Fully automated microplate system noNumber of each analyte performed in separate disposable unit —Number of wells in microplate —

Methods supported/Separation methods fluorescence, enzyme immunoassay/beadNumber of different measured assays onboard simultaneously 45Number of different assays programmed, calibrated at once entire menu

Number of user-definable (open) channels —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

unitized test cup/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 72 hours/3 days/noMultiple reagent configurations supported noReagent container placed directly on system for use yesReagents barcoded/Information in barcode yes/test, lotSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable tips)Walkaway capacity in minutes/Specimens/Tests, assays 30/45/45System is open (homebrew methods can be used)/Liquid or dry system no/dryUses disposable cuvettes/Maximum number stored no/—Uses washable cuvettes/Replacement frequency no/—Minimum specimen volume required 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL

Supplied with UPS (backup power)/Requires floor drain yes/noRequires dedicated water system/Water consumption no/—Noise generated —Has dedicated pediatric sample cup/Dead volume no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 100; 16 × 75, 100/noSample barcode reading capability/Autodiscrimination yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A —Onboard test auto inventory (determines volume in container) yesMeasures number of tests remaining/Short sample detection yes/yesAutomatic detection of adequate reagent or specimen yesClot detection/Reflex testing capability yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/noDilution of patient samples onboard/Automatic rerun capability yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no

Time between initial result and reaspiration of sample for rerun 20 minutesAutocalibration or autocalibration alert noNumber of calibrators required for each analyte 2 or 6

Calibrants can be stored onboard/Average calibration frequency no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yesHow often QC required 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yesAutomatic shutdown/Startup is programmable/Startup time no/no/10 minutes

Stat time to completion of βhCG test ~18 minutesTime delay from ordering stat test to aspiration of sample 1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

30/90 (0.67-minute sample cycle)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/noData-management capability/Instrument vendor supplies LIS interface no/noLIS interfaces up and running in active user sites all major LIS suppliers

LIS interface operates simultaneously with running assays yesBidirectional interface capability yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no

Can order (via modem) malfunctioning part(s) without operator noOn-site response time of service engineer 24 hoursMean time between failures/To repair failures —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 15 minutes; monthly: 20 minutesOnboard maintenance records/Maintenance training demo module no/no

List price/Targeted bed size or daily volume $60,000 base model/500+ monthlyAnnual service contract cost (24 hours/7 days) $6,000 base modelTraining provided with purchase/Advanced operator training —/no



3 models (base model, base model plus 9-tray sorter, base model plus 19-tray sorter) offer increasing automation and capacity; connections and software built in for all 3 models; unitized test cups, no reagent preparation; automated sample dilution, pretreatment, automated reschedule, retest


JUNE 2016 page 59


Part 21 of 21 TOSOH BioscienceSusan Kolarik [email protected]


6000 Shoreline Ct., Ste. 101, South San Francisco, CA 94080800-248-6764 www.tosoh.com

Name of instrument/First year sold/Where designed AIA-900/2011/JapanCountry where manufactured/Where reagents manufactured Japan/JapanNumber of units in clinical use in U.S./Outside U.S. 320/1,300Operational type/Model type/Sample handling system continuous random access/floor standing/rackDimensions in inches (H × W × D)/Instrument footprint in sq. feet 35.04, 50.79, or 58.64 × 26.18 × 49.09/6–10

Tests available on instrument in U.S. TSH, 3rd-gen. TSH, T4, TT3, TU, FT4, FT3, TPOAb, TgAb, BHCG, estradiol, FSH, LHII, progesterone, prolactin, testosterone, AFP, CEA, PSA, CA125, CA19-9, 27.29, β2 microglobulin, C-peptide, insulin, IgEII, PAP, cortisol, HGH, B12, folate, RBC folate, ferritin, intact PTH, CK-MB, myoglobin, cTnI second generation, HbA1c, cystatin C, ACTH, DHEA-S, homocysteine, vitamin D, SHBG, HCG, hsE2

Tests not available in U.S. but submitted for clearance Tg

Tests not available in U.S. but available in other countries BNP, HBsAg, HBsAb, HBcAb, HBeAb, cTnI third generation, PSA II, TrAb, HCVAb, HCG, free PSA, D-dimer, wPTH, osteocalcin, PIVKA

Tests in development presepsin, scc

Tests not available on other manufacturers’ analyzers —

Fully automated microplate system noNumber of each analyte performed in separate disposable unit —Number of wells in microplate —

Methods supported/Separation methods fluorescence, enzyme immunoassay/beadNumber of different measured assays onboard simultaneously 45Number of different assays programmed, calibrated at once entire menu

Number of user-definable (open) channels —Number of different analytes for which system accommodates reagent containers onboard at once/Tests per container set

unitized test cup/unitized test cup

Shortest/Median onboard reagent stability/Refrigerated onboard 72 hours/3 days/noMultiple reagent configurations supported noReagent container placed directly on system for use yesReagents barcoded/Information in barcode yes/test, lotSame capabilities when 3rd-party reagents used/Susceptibility to carryover no/zero (disposable tips)Walkaway capacity in minutes/Specimens/Tests, assays 30/45/45System is open (homebrew methods can be used)/Liquid or dry system no/dryUses disposable cuvettes/Maximum number stored no/—Uses washable cuvettes/Replacement frequency no/—Minimum specimen volume required 10 µLMinimum sample volume aspirated precisely at once/Minimum dead volume 10 µL/100 µL

Supplied with UPS (backup power)/Requires floor drain yes/noRequires dedicated water system/Water consumption no/—Noise generated —Has dedicated pediatric sample cup/Dead volume no/—Primary tube sampling/Tube sizes/Pierces caps on primary tubes yes/13 × 75, 100; 16 × 75, 100/noSample barcode reading capability/Autodiscrimination yes (2 or 5 interleaved, Codabar, codes 39 and 128)/yesBarcode placement per CLSI standard Auto2A —Onboard test auto inventory (determines volume in container) yesMeasures number of tests remaining/Short sample detection yes/yesAutomatic detection of adequate reagent or specimen yesClot detection/Reflex testing capability yes/noHemolysis detection-quantitation/Turbidity detection-quantitation no/noDilution of patient samples onboard/Automatic rerun capability yes/yesSample volume can be reduced to rerun out-of-linear range high results/ Increased to rerun out-of-linear range low results

yes/no

Time between initial result and reaspiration of sample for rerun 20 minutesAutocalibration or autocalibration alert noNumber of calibrators required for each analyte 2 or 6

Calibrants can be stored onboard/Average calibration frequency no/90 daysMultipoint calib. supported/Multiple calibs. stored for same assay yes/yesHow often QC required 24 hoursOnboard real-time QC/Support multiple QC lot Nos. per analyte no/yesAutomatic shutdown/Startup is programmable/Startup time no/no/10 minutes

Stat time to completion of βhCG test ~18 minutesTime delay from ordering stat test to aspiration of sample 1 minuteThroughput per hour for three analytes on each specimen, in number of specimens/Number of tests (cycle time)

30/90 (0.67-minute sample cycle)

Can autotransfer QC results to LIS/Onboard capability to review QC yes/noData-management capability/Instrument vendor supplies LIS interface no/noLIS interfaces up and running in active user sites all major LIS suppliers

LIS interface operates simultaneously with running assays yesBidirectional interface capability yes (broadcast download and host query)Interface available (or will be) to auto specimen handling system noModem servicing/Can diagnose own malfunctions/ Determine malfunctioning component

no/no/no

Can order (via modem) malfunctioning part(s) without operator noOn-site response time of service engineer 24 hoursMean time between failures/To repair failures —Average time to complete maintenance by lab personnel daily: 5 minutes; weekly: 15 minutes; monthly: 20 minutesOnboard maintenance records/Maintenance training demo module no/no

List price/Targeted bed size or daily volume $60,000 base model/500+ monthlyAnnual service contract cost (24 hours/7 days) $6,000 base modelTraining provided with purchase/Advanced operator training —/no



3 models (base model, base model plus 9-tray sorter, base model plus 19-tray sorter) offer increasing automation and capacity; connections and software built in for all 3 models; unitized test cups, no reagent preparation; automated sample dilution, pretreatment, automated reschedule, retest


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JUNE 2016 page 30 - CAP TODAY