NOVEMBER 2018 page 67 - CAP TODAY€¦ · size; reliable: system averages one service call per year; easy to use: system has touchscreen software with intuitive icons and minimal

NOVEMBER 2018 page 67

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.

HEMATOLOGY ANALYZERS NOVEMBER 2018 | CAP TODAY 67

Part 1 of 13

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

Abbott Diagnostics Abbott Diagnostics Abbott DiagnosticsChristy Thiessen [email protected] Christy Thiessen [email protected] Christy Thiessen [email protected] Park, IL Abbott Park, IL Abbott Park, IL800-323-9100 www.abbottdiagnostics.com 800-323-9100 www.abbottdiagnostics.com 800-323-9100 www.abbottdiagnostics.com

Name of instrument CELL-DYN Emerald* CELL-DYN Emerald 22* CELL-DYN Ruby*First year installed in U.S./Outside U.S./No. of units sold in 2017 2009/2008/— 2016/2016/— 2006/2006/ —No. units installed in U.S./Outside U.S./List price >1,700/>2,800/$30,000 —/—/$64,000 >550/>2,700/$185,000Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV,

MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, lymph %&#, gran %&#, mid %&#, RDW, MPV

standard menu (left) plus: RDW, MPV standard menu (left) plus: MPV, RDW, retic %&#

• Laboratory — — — • Flags dispersional data alerts, suspect measurand flags, and

count invalidation flagsdispersional data alerts, suspect parameter flags, and count invalidation flags

NRBC, FWBC, NWBC, RRBC, band, IG, blast, variant lymph, RBC morph., DFLT, MCHC, LRI, URI, LURI, ATYPDEP, high-low interp. message, WBC

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — — —Tests unique to analyzer — — atypical depolarization flag

Differential method(s) used impedance counting UNI-FLOW Optical Technology MAPSS (multi-angle polarized scatter separation)Analytical measurement range: • WBC count/RBC count 0.4–96.1 K/µL/0.22–7.61 M/µL 0.4–90 K/µL/1.2–8.3 M/µL 0.02–246 × 103/µL/0.00–7.50 × 106/µL • Hemoglobin/Platelet 3.3–24.6 g/dL/9–1,375 K/µL 5.5–22 g/dL/11–1,485 K/µL 0.00–25.0 g/dL/0.00–3,000 × 103/µL • MCV (fL) or Hct (%) 48.8–115 (MCV), 5.3–75.6% (Hct) 53.2–118.4 (MCV), 12.1–66.1 fL (Hct) 58–139 (MCV), 8.3–79.8% (Hct) • Reticulocytes — — —

Precision: • WBC count/RBC count 3.5% (95% confidence limit)/2.0% (95% confid. limit) 0.8–2.3% CV/0.7–1.4% CV 2.4%/1.8% • Hemoglobin/Platelet 2.1% (95% confidence limit)/6.1% (95% confid. limit) 0.2–0.9% CV/2.2–5.2% CV 1.4%/3.8% • MCV or Hct 0.8% MCV (95% confid. limit), 1.7% Hct (95% confid. limit) 0.3–0.6% CV (MCV), 0.8–1.5% CV (Hct) 0.8% (MCV)Accuracy of automated differential compared with manual differential (per CLSI H20-A2)

— — neut% r=0.983, slope=0.97, y=-1.98; lymph% r=0.921, slope=0.95, y=0.94; mono% r=0.711, slope=1.10, y=1.93; eos% r=0.952, slope=1.04, y=0.01; baso% r=0.146, slope=0.18, y=1.22

Interfering substances: • WBC cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants

cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants

fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin

• RBC cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/µL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells

cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/µL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells

elevated WBC, increased numbers of giant PLTs, autoagglutination, in vitro hemolysis

• MCV or Hct cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/µL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells, reduced red cell deformability, swollen red cells

cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/µL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells, reduced red cell deformability, swollen red cells

MCV: elevated WBC, hyperglycemia, in vitro hemolysis, increased number of giant PLTs

• Platelet cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet clumping, platelet satellitosis

cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet clumping, platelet satellitosis

WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulin, PLT clumping, increased number of giant PLTs

• Hemoglobin carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/µL), hyperbilirubinemia, lipemia, monoclonal proteins

carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/µL), hyperbilirubinemia, lipemia, monoclonal proteins

elevated WBC, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs

Interfering substances: differential platelet aggregates, NRBCs, giant platelets, cryoglobulin, incomplete lysis of RBCs, small lymphocytes, fibrin clots, shift in WBC cell distrib. due to EDTA anticoagulant equilibration

platelet aggregates, NRBCs, giant platelets, cryoglobulin, incomplete lysis of RBCs, small lymphocytes, fibrin clots, shift in WBC cell distrib. due to EDTA anticoagulant equilibration

fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulin, paraproteins

Maximum CBCs per hour/Maximum CBCs and differentials per hour 57/57 45/45 84/84Minimum specimen volume open/Closed/Sample dead volume closed 9.8 µL/—/— 17 µL/—/— 150 µL/230 µL/1.2 mLMicrosample capability no no noPrepares microscope slides automatically or flags problems for slide prep yes yes yesNumber of automatic slidemakers available/List price — — —/$125,000Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/yesMaximum archived data accessible when system online 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on

internal memory10,000 results

No. specimens for which numeric results saved in memory at once 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on internal memory

10,000 results

No. specimens for which histo/cytogram results saved in memory at once 300,000 on USB and 1,500 results on internal memory 300,000 on USB and 1,000 records with histograms on internal memory

10,000 results

Performs delta checks no no noTags and holds results for follow-up, confirmatory testing, or rerun no no yesParameters for flags for holding samples defined by user or vendor no no user or vendorScattergram display: cell-specific color no yes yesHistogram display: color with thresholds no yes yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported proprietary (instrument or vendor specific) proprietary (instrument or vendor specific) LIS1/LIS2 CLSIInformation transferred on LIS interface numeric and flag results, instrument to LIS numeric and flag results, instrument to LIS numeric and flag results, histograms and scatterplots,

instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders

LOINC codes transmitted with all results/Sent in message to LIS/ Listing of machine codes and corresponding LOINC for each test

no/no/no no/no/no no/no/no

Interface available or planned to automated specimen-handling system none none noneBarcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5, Chinese post,

code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E

Codabar, codes 39 and 128, Interleaved 2 of 5, Chinese post, code 39 full ASCII, code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E

Codabar, codes 39 and 128, Interleaved 2 of 5, ISBT

Accommodates barcode placement per CLSI standard AUTO02-A2 yes yes yes

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2 1/2 1/3Time required for daily, weekly, monthly maintenance daily: none; monthly: ~5 min.; biannually: ~10 min. weekly: 15 minutes; quarterly: 2 minutes daily: 30 seconds; weekly: 5 minutes; monthly: 10

minutes (times are estimated)Onboard diagnostics for troubleshooting/Limited to software problems no/no no/no yes/noManufacturer can perform diagnostics via modem no no 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

small: sample size, reagent volumes used, and physical size; reliable: system averages one service call per year; easy to use: system has touchscreen software with intuitive icons and minimal layers

*refer to CELL-DYN Emerald operator’s manual for warnings, limitations, and precautions

small physical footprint, only 3 reagents used (2 of 3 reagents stored onboard), and built-in monitor; automated start-up, shut-down, and cleaning; 5-part differential using UNI-FLOW optical flow cytometry technology with a patented lyse allowing for clear separation of the 5 WBC populations

*refer to CELL-DYN Emerald 22 operator’s manual for warnings, limitations, and precautions

touch-sensitive screen, all optical technology; onboard maintenance videos; lyse-resistant RBC mode; rules-based result annotations

*refer to CELL-DYN Ruby operator’s manual for warnings, limitations, and precautions



HEMATOLOGY ANALYZERS68 CAP TODAY | NOVEMBER 2018

Part 2 of 13


Abbott Diagnostics Beckman Coulter Beckman CoulterChristy Thiessen [email protected] Matthew Rhyner [email protected] Matthew Rhyner [email protected] Park, IL Miami, FL Miami, FL800-323-9100 www.abbottdiagnostics.com 305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com

Name of instrument CELL-DYN Sapphire* Coulter Ac•T 5diff Family; Ac•T 5diff AL DxH Connected WorkcellFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2005/2005/— 2001/2000/—; 2003/2003/— 2014/2014/—No. units installed in U.S./Outside U.S./List price >165/>750/$250,000 >1,400/>3,900 combined inside, outside of U.S./

$38,500 (OV and CP), $54,500 (AL)100/200/$690,000

Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)

standard menu (left) plus: MPV, RDW, retic %&#, IRF, NRBC %&#, CD61, CD3T %&#, CD4T %&#, CD8T %&#, 4/8

standard menu (left) plus: RDW, MPV standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, RDW-CV, RDW-SD, automated retic #, retic %; body fluids: total nucleated count and RBC count for synovial, serous, CSF fluids, and slidemaking

• Laboratory — — — • Flags band, IG, blast, variant lymph, nvWBC, rstRBC, IR, PLT

clump, ASYM, FP, CD61 agglutination, clot detected aspiration, short sample

complete operator selectable flagging suspect, system, and exception messages for samples requiring review

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — PCT, PDW, IMM, ATL body fluid mononuclear %&#, body fluid polymorphonuclear

%&#, early granulated cells %&#, high light scatter reticulocytes %&#, low hemoglobin density, microcytic anemia factor, mean sphered cell volume, plateletcrit, platelet distribution width, reticulocyte distribution width, more

Tests unique to analyzer CD61 for PLTs, CD3/4, CD3/8 (immuno T-cell) — —

Differential method(s) used MAPSS (multi-angle polarized scatter separation) and three-color fluorescence

ACV technology combining cytochemistry, focused flow impedance, and light absorbance principles of measurement

Automated Intelligent Morphology using volume, conductivity, and five angles of light scatter, digital signal processing, advanced algorithm applications, high-definition cellular resolution, DataFusion

Analytical measurement range: • WBC count/RBC count 0.0–250.0 × 103/µL/0.0–7.50 × 106/µL OV: 0.4–90.0/0.23–7.70; CP: 0.4–91.3/0.30–8.0; AL: 0.4–120.0/0.3–8.0

0.050–400.000/0.005–8.500

• Hemoglobin/Platelet 1.0–25.0 g/dL/0.0–2,000 × 103/µL OV: 0–22.9/4–1,000; CP: 0.0–22.0/10.0–1,000; AL: 1.3–24.0/10.0–1,000 (100.0–1,900)

0.10–25.50/3.0–3,000.0

• MCV (fL) or Hct (%) 37.0–179.0 fL (MCV) OV: 1.8–55.9, 56.0–63.8 (Hct); CP: 1.8–55.9, 56.0–63.8 (Hct); AL: 2.0–67.0 (Hct)

0.00–85.00 (Hct) for operating range, 50.00–150.00 (MCV) for measuring range

• Reticulocytes 0.0–1,500 × 103/µL — 0.000–30.000

Precision: • WBC count/RBC count <2.7%/≤1.5% <2%/<2% ≤3.0%/≤1.5% • Hemoglobin/Platelet ≤1.0%/≤4.0% <1%/<5% ≤1.5%/≤3.5% • MCV or Hct ≤1.0% (MCV) <2.0% (Hct) ≤1.0% (MCV)

Accuracy of automated differential compared with manual differential (per CLSI H20-A2)

neut% r=0.942, slope=0.947, y=0.446; lymph% r=0.936, slope=0.943, y=2.811; mono% r=0.623, slope=1.057, y=0.851; eos% r=0.446, slope=1.024, y=0.288; baso% r=0.232, slope=0.257, y=0.350

not available in NCCLS H-20A format neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or 10%, whichever is greater)

Interfering substances: • WBC PLT clumps, neutrophil aggregates, HbC crystals, lyse-resistant RBCs, cryoglobulin, cryofibrinogen, fragile WBC, NRBCs

NRBCs, PLT clumps, large PLTs, lyse-resistant RBCs precipitated elevated proteins, cryoglobulin, fragmented white cells, agglutinated white cells, lyse-resistant RBCs, giant PLTs, PLT clumps, unlysed particles >35 fL in size

• RBC autoagglutination, cold agglutinins, elevated WBC, giant PLTs, hemolysis, sm WBC

cold agglutinins, PLT clumps, WBC overlinearity very high WBC count, high concentration of very large platelets, autoagglutinins

• MCV or Hct autoagglutination, cold agglutinins, elevated WBC, giant PLTs, hemolysis, hyperglycemia

Hct: lipemic samples, high WBC, cold agglutinins very high WBC count, high concentration of very large platelets, autoagglutinins

• Platelet auto and cold agglutinins, cryoglobulin, cryofibrinogen, giant PLT, micro RBCs, PLT clumps, RBC fragments, WBC fragments, PLT satellitism

RBC and WBC fragments platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electronic noise

• Hemoglobin lipids>700 mg/dL, WBCs>250 × 109/L, bilirubin>33 mg/dL, HbC crystals

elevated WBC, lipemia severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing

Interfering substances: differential see WBC lyse-resistant RBCs, NRBCs, lipemia elevated triglycerides, precipitated elevated proteins, hypogranular granulocytes, agranular granulocytes, lyse-resistant red cells, very small or multipopulation lymphocytes

Maximum CBCs per hour/Maximum CBCs and differentials per hour 105/105 60/60; 80/80 300/300Minimum specimen volume open/Closed/Sample dead volume closed 120 µL/120 µL/0.5 mL, 0.3 mL for 10.25 × 64 mm tubes 30 µL for CBC and 53 µL for CBC and differential/30 µL for

CBC and 53 µL for CBC and differential/varies by tube size165 µL/165 µL/300–400 µL

Microsample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep yes no yesNumber of automatic slidemakers available/List price — /$125,000 — —/DxH SMS $165,000Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes —/yesMaximum archived data accessible when system online 10,000 results 10,000 samples 90,000 standaloneNo. specimens for which numeric results saved in memory at once 10,000 results 10,000 samples 90,000 standaloneNo. specimens for which histo/cytogram results saved in memory at once 10,000 results 10,000 samples 90,000Performs delta checks yes no yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor user or vendor user or vendor yesScattergram display: cell-specific color yes no yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes yes yesLIS interface formats supported ASTM 1394 proprietary; proprietary ASTM CLSI LIS1-AInformation transferred on LIS interface numeric and flag results, instrument to LIS; patient

demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders

numeric and flag results, histograms and differential plots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders (available with release of workcell)


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

Interface available or planned to automated specimen-handling system none no Beckman CoulterBarcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5, EAN 8 and 13 Codabar, codes 39 and 128, Interleaved 2 of 5, NW7Accommodates barcode placement per CLSI standard AUTO02-A2 yes yes yesNo. of cleaning or maintenance reagents/No. of routine liquid reagents 0/4 5/4 1/4Time required for daily, weekly, monthly maintenance daily: 30 seconds; weekly: 10 minutes; monthly:

5 minutes (times are estimated)none automated shutdown programmable with <1 minute

user time dailyOnboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem yes no yesDistinguishing features (supplied by company)


4 optical and 3 fluorescent detectors provide multiple scatter plot analysis; 2D optical platelets prevent interferences; fluorescent analysis of reticulocytes, NRBCs, and 3-color monoclonal analysis; OpenFlow MAb test selections; touch-sensitive screen, interfaces to Accelerator a3600 track system*refer to CELL-DYN Sapphire operator’s manual for warnings, limitations, and precautions

quantitative 5-part WBC differential; aspirates only 30 µL of sample; requires small space footprint and runs quietly; AL has auto repeat based on decision rules

reduces turnaround time without the need for track-based automation; Automated Intelligent Morphology provides 3 independent counts for RBC, WBC, PLT; blast flagging by cell lineage; reliable MPV and reliable hemoglobin with few interferences




Part 3 of 13


Beckman Coulter Beckman Coulter Beckman CoulterMatthew Rhyner [email protected] Matthew Rhyner [email protected] Mirta Gamez [email protected], FL Miami, FL Miami, FL305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com 305-380-3800 www.beckmancoulter.com

Name of instrument DxH 600 DxH 800 Unicel DxH 900First year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2013/— 2008/2008/— 2018/2018/>96 (Q2 2018)No. units installed in U.S./Outside U.S./List price >600/>100/$209,000 >2,000/>1,500/$229,000 55/29/$259,600Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV,

MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, RDW-CV, RDW-SD, automated retic #, retic %; body fluids: total nucleated count and RBC count for synovial, serous, CSF fluids

standard menu (left) plus: IRF, MPV, MRV, NRBC %&#, RDW-CV, RDW-SD, automated retic #, retic %; body fluids: total nucleated count and RBC count for synovial, serous, and CSF fluids

standard menu (left) plus: retic and extended retic panel: automated retic #&%, MRV, IRF; extended platelet panel: MPV; extended RBC panel: NRBC %&#, RDW-CV, RDW-SD; body fluids: total nucleated count, RBC count for synovial, serous, CSF, and BAL fluids

• Laboratory — — — • Flags suspect, system, and exception messages for samples

requiring reviewflags and codes for values requiring review: suspect, system, and exception messages for samples requiring review

suspect messages: Abn hemoglobin, cellular inter, dimorphic reds, giant platelets, imm grans, left shift, LY blast, MO blast, NE blast, NRBC, RBC frag/micro, red cell aggl, sickled cells, variant LY, H&H check; customizable definitive messages and system messages; unlimited customizable lab flagging: free text for direction at the scope

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — Early Sepsis IndicatorTests in development — — immature granulocyte: IG%Tests for research use only body fluid mononuclear %&#, body fluid polymorphonuclear

%&#, early granulated cells %&#, high light scatter reticulocytes %&#, low hemoglobin density, microcytic anemia factor, mean sphered cell volume, plateletcrit, platelet distribution width, reticulocyte distribution width, more

body fluid mononuclear %&#, body fluid polymorphonuclear %&#, early granulated cells %&#, high light scatter reticulocytes %&#, low hemoglobin density, microcytic anemia factor, mean sphered cell volume, plateletcrit, platelet distribution width, reticulocyte distribution width (RDWR and RDWR-SD), red cell size factor, unghosted red cells %&#, leukocyte estimates (UWROP, WDOP, WNOP, WROP), cell population data research parameters

body fluid mononuclear %&#, body fluid polymorphonuclear %&#, early granulated cells %&#, high light scatter reticulocytes %&#, low hemoglobin density, microcytic anemia factor, mean sphered cell volume, plateletcrit, platelet distribution width, reticulocyte distribution width, more

Tests unique to analyzer — — extended retic panel: MRV; direct count MPV, MCV, MDW, CMD parameters

Differential method(s) used Automated Intelligent Morphology using volume, conductivity, and 5 angles of light scatter, digital signal processing, advanced algorithm applications, high-definition cellular resolution, DataFusion

Automated Intelligent Morphology using volume, conductivity, and 5 angles of light scatter, digital signal processing, advanced algorithm applications, high-definition cellular resolution, DataFusion

biophysical characterization of blood cells with 5 light-scatter angles, digital conductivity, and enhanced Coulter Principle; WBC flagging

Analytical measurement range: • WBC count/RBC count 0.050–400.000/0.005–8.500 0.050–400.000/0.005–8.500 0.050–2.000 × 103 cells/µL/0.005–8.500 × 106 cells/µL • Hemoglobin/Platelet 0.10–25.50/3.0–3,000.0 0.10–25.50/3.0–3,000.0 0.10–25.50 g/dL/3.0–3,000.0 × 103 cells/µL • MCV (fL) or Hct (%) 50.00–150.00 (MCV) 0.00–85.00 (Hct) for operating range, 50.00–150.00

(MCV) for measuring range 50.00–150.00 fL

• Reticulocytes 0.000–30.000 0.000–30.000 0.000–30.000

Precision: • WBC count/RBC count ≤3.0%/≤1.5% ≤3.0%/≤1.5% ≤3.0%/≤1.5% • Hemoglobin/Platelet ≤1.5%/≤3.5% ≤1.5%/≤3.5% ≤1.5%/≤3.5% • MCV or Hct ≤1.0% (MCV) ≤1.0% (MCV) ≤1.0% (MCV)


neut= ±2.0; lymph, mono= ±3.0; eso, baso= ±1.0 (or 10%, whichever is greater)



Interfering substances: • WBC precipitated elevated proteins, cryoglobulin, fragmented white cells, agglutinated white cells, lyse-resistant RBCs, giant PLTs, PLT clumps, unlysed particles >35 fL in size

precipitated elevated proteins, cryoglobulin, fragmented white cells, agglutinated white cells, lyse-resistant RBCs, giant PLTs, PLT clumps, unlysed particles >35 fL in size

possibly: precipitated elevated proteins, cryoglobulin, frag-mented white cells, agglutinated white cells, lyse-resistant RBCs, giant PLTs, PLT clumps, unlysed particles >35 fL

• RBC very high WBC count, high concentration of very large platelets, autoagglutinins

very high WBC count, high concentration of very large platelets, autoagglutinins

possibly: very high WBC count, high concentration of very large platelets, autoagglutinins

• MCV or Hct very high WBC count, high concentration of very large platelets, autoagglutinins

very high WBC count, high concentration of very large platelets, autoagglutinins

possibly: very high WBC count, high concentration of very large platelets, autoagglutinins

• Platelet platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electronic noise

platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electronic noise

possibly: platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electronic noise

• Hemoglobin severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing

severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing

possibly: severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing

Interfering substances: differential elevated triglycerides, precipitated elevated proteins, hypogranular granulocytes, agranular granulocytes, lyse-resistant red cells, very small or multipopulation lymphocytes

elevated triglycerides, precipitated elevated proteins elevated triglycerides, precipitated elevated proteins, hypo-granular granulocytes, agranular granulocytes, lyse-resistant red cells, very small or multipopulation lymphocytes

Maximum CBCs per hour/Maximum CBCs and differentials per hour >100/>90 >100/>90 300 samples/300 samplesMinimum specimen volume open/Closed/Sample dead volume closed 165 µL/165 µL/250–400 µL 165 µL/165 µL/250–400 µL 165 µL/165 µL/250–400 µLMicrosample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep yes yes noNumber of automatic slidemakers available/List price —/DxH SMS $165,000 —/DxH SMS $165,000 —Archives patient data/Previous patient results incl. with recent results —/no yes/no yes/yesMaximum archived data accessible when system online 40,000 standalone 40,000 standalone 50,000 patient results w/histograms, scatterplots, demographicsNo. specimens for which numeric results saved in memory at once 40,000 standalone 40,000 standalone 50,000 patient results w/histograms, scatterplots, demographicsNo. specimens for which histo/cytogram results saved in memory at once 40,000 40,000 50,000 patient results w/histograms, scatterplots, demographicsPerforms delta checks yes yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor yes yes yesScattergram display: cell-specific color yes yes yes (WBC, nRBC, reticulocyte)Histogram display: color with thresholds yes yes yes (WBC, RBC, PLT)User interface can display choice of specimen or result information yes yes yesLIS interface formats supported CLSI LIS01-A2 CLSI LIS01-A2 CLSI LIS01-A2Information transferred on LIS interface numeric and flag results, histograms and scatterplots,

instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders (available with release of workcell)

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders (available with release of workcell)

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders


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

Interface available or planned to automated specimen-handling system Beckman Coulter Beckman Coulter Beckman CoulterBarcode symbologies read on specimen tube Codabar, codes 39 and 128, interleaved 2 of 5, NW7 Codabar, codes 39 and 128, interleaved 2 of 5, NW7 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5, NW7Accommodates barcode placement per CLSI standard AUTO02-A2 yes yes yesNo. of cleaning or maintenance reagents/No. of routine liquid reagents 5/7 5/7 1 pre-loaded cube with up to 30 cleaning cycles/3 for

CBC/diff incl. Coulter Plt, 1 for retic, extended retic panelTime required for daily, weekly, monthly maintenance automated shutdown programmable with <1 minute

user time dailyautomated shutdown programmable with <1 minute user time daily

daily: 30 min.; weekly: none; monthly: none; as needed

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem yes yes yesDistinguishing features (supplied by company)


Automated Intelligent Morphology provides 3 independent counts for RBC, WBC, PLT; blast flagging by cell lineage; reliable MPV and reliable hemoglobin with few interferences; upper-level linearity for body fluids minimizes dilution steps; 48–72 hour sample stability on CBC parameters

Automated Intelligent Morphology provides 3 independent counts for RBC, WBC, PLT; blast flagging by cell lineage; reliable MPV and reliable hemoglobin with few interferences; 48–72 hour sample stability on CBC parameters

DataFusion uses real-time analytics and bypasses special modes, avoiding reruns; platelets achieve industry-leading accuracy, precision, and low backgrounds with first-pass technology; near-native state RBC analysis throughout the maturation cycle for direct read and accurate indices




Part 4 of 13


Beckman Coulter CellaVision Clinical Diagnostic SolutionsMirta Gamez [email protected] Ken Childs [email protected] [email protected], FL Durham, NC Plantation, FL305-380-3800 www.beckmancoulter.com 919-806-4420 www.cellavision.com 954-791-1773 www.cdsolinc.com

Name of instrument Unicel DxH SMS II CellaVision DM9600/DM1200 Medonic M-SeriesFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2018/2018/— 2004/2003/— 2006/—/250No. units installed in U.S./Outside U.S./List price 13/9/$177,100 —/—/~$135,000–$175,000 2,000/>25,000/$21,089Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV,

MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)— neut %&#, mono, lymph, eos, baso, segmented, bands,

blast, promyelocytes, myelocytes, metamyelocytes, variant lymphocytes, plasma cells, giant platelets, platelet clumps, erythroblasts; RBC morphology pre-characterizations include anisocytosis, poikilocytosis, polychromasia, microcytosis, macrocytosis, hypochromia

WBC, RBC, HGB, Hct, MCV, MCH, MCHC, PLT, gran %&#, mid, lymph, RDW, MPV

• Laboratory — — —

• Flags P flag printed on slide to denote blood detector detected aspiration error

— —

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — — —

Tests unique to analyzer — analysis of cytocentrifuged samples, body fluids (reported parameters: neutrophils, eosinophils, lymphocytes, macrophages, including monocytes), other (basophils, lymphoma cells, atypical lymphocytes, blast cells, tumor cells)

micro-pipette adaptor for capillary sampling

Differential method(s) used — light microscopy, image analysis, and artificial neural networks

impedance

Analytical measurement range: • WBC count/RBC count — — 0.5–80.0/0.5–7.00 • Hemoglobin/Platelet — — 2.0–23.0/30–1,800 • MCV (fL) or Hct (%) — — — • Reticulocytes — — —Precision: • WBC count/RBC count — — 7.0 × 109/L, ≤1.8% (OT CV)/4.59 × 1012/L, ≤0.9% (OT CV) • Hemoglobin/Platelet — — 14.3 g/dL, ≤0.8% (OT CV)/239 × 109/L, ≤3.0% (OT CV) • MCV or Hct — — MCV: 86.8 fL/≤0.5% (OT CV)


— seg neut% y=0.97x+1.3, r= 0.987; lymph% y=0.97x + 1.2, r= 0.979; eos% y=1.01+0.1, r=0.960; mono% y=0.97+0.2, r=0.941; band neut% y=0.87x+0.1, r=0.917

—

Interfering substances: • WBC none — NRBCs, unlysed RBCs, hemolysis, leukemias, chemotherapy, cryoglobulins, multiple myeloma, lymphocyte count interference

• RBC none — leukocytosis with concurrent anemia, agglutinated RBCs, cold agglutinins

• MCV or Hct none — red blood cell agglutination, WBC, thrombocytosis

• Platelet none — microcytosis, agglutinated RBCs, giant platelets in excessive numbers, chemotherapy, hemolysis, ACD blood, RBC inclusions, platelet agglutination

• Hemoglobin none — unlysed RBCs, leukocytosis, lipemia, hyperproteinemia, hyperbilirubinemia, fetal blood

Interfering substances: differential none — factors that affect WBC (above) plus: large lymphocytes, atypical lymphocytes, blasts, basophils in excessive numbers, metamyelocytes, myelocytes, promyelocytes, blasts and plasma cells in excessive numbers

Maximum CBCs per hour/Maximum CBCs and differentials per hour 140 slides/— —/35 differentials >60/>60Minimum specimen volume open/Closed/Sample dead volume closed 90 µL/90 µL/250–400 µL — <110 µL/<250 µL/1 mLMicrosample capability yes — yesPrepares microscope slides automatically or flags problems for slide prep yes — noNumber of automatic slidemakers available/List price —/$177,000 — —

Archives patient data/Previous patient results incl. with recent results no/no yes/no no/noMaximum archived data accessible when system online — unlimited —No. specimens for which numeric results saved in memory at once — ~4,000 >1,000 samplesNo. specimens for which histo/cytogram results saved in memory at once — — >1,000 samplesPerforms delta checks no no noTags and holds results for follow-up, confirmatory testing, or rerun no — noParameters for flags for holding samples defined by user or vendor no — user-definable rangesScattergram display: cell-specific color no — noHistogram display: color with thresholds no — yesUser interface can display choice of specimen or result information yes — yes

LIS interface formats supported ASTM 1394, ASTM 1238, IEEE MIB, CLSI LIS1-A, CLSI LIS2-A ASTM 1394 XML/SerialInformation transferred on LIS interface patient demographics, LIS to instrument—broadcast;

host query for patient demographics and ordersnumeric and flag results, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders

numeric and flag results, histograms and scatterplots, instrument to LIS


no/no/no no/no/yes (for peripheral blood) no/no/no

Interface available or planned to automated specimen-handling system Beckman Coulter — —Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5,

NW7Codabar, codes 39 and 128, Interleaved 2 of 5, QR, DataMatrix

—

Accommodates barcode placement per CLSI standard AUTO02-A2 yes — —

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1 pre-loaded cube with up to 30 cleaning cycles/3 (can vary): stain, buffer, diluent

none/1 1/1

Time required for daily, weekly, monthly maintenance daily: up to 20 min.; weekly: up to 30 min.; monthly: as needed

daily: none; weekly: 5 minutes daily: a few minutes; monthly: 10 minutes; 6 months: 75 minutes

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem yes no no



hemasphere technology analyzes to overcome variations in blood characteristics to produce an exceptional monolayer smear; flexible rule writing allows for up to 16 slides seamlessly triggered by customizable CBC or specific flag results; blood detector for sample check, flagging directly on slide to note aspiration integrity gaps alerting user

fully automated slide handling and oiling available in two models for medium and large laboratories; performs peripheral blood and body fluid differentials; WBC and other nucleated cells classified into 18 different categories; RBC morphology characterized for 6 categories; network use allows remote review of blood smears and linking of multiple analyzers in multiple locations

micro-pipette adaptor for capillary sampling; only 3-part diff with auto sampling capability; no weekly maintenance




Part 5 of 13


Diatron MI Diatron MI HORIBA MedicalFrank Matuszak [email protected] Frank Matuszak [email protected] Jim Knowles [email protected], FL Medley, FL Irvine, CA833-228-7931 www.diatron.com 833-228-7931 www.diatron.com 888-903-5001 ext. 4553 www.horiba.com/us/en/medical

Name of instrument Abacus 3CP Abacus 5 Pentra XLRFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2013/481 2013/2009/658 2016/2015/—No. units installed in U.S./Outside U.S./List price 56/1,039/$20,385 35/3,120/$31,850 —/—/$77,500


WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, mono, lymph, RDW%, MPV, GRA%, GRA#

standard menu (left) plus: RDW-SD, RDW-CV, MPV standard menu (left) plus: retic %&#, IRF%, CRC%

• Laboratory — — — • Flags range flags, measurement condition flags, parameter

warning and error flagspathological flags, lab limits (normal ranges), reagents alert, instrumental alerts

operator selectable flagging

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — — —

Tests unique to analyzer — — automatic dilution for over range WBC and platelet

Differential method(s) used volumetric impedance method, light absorbance for HGB measurement

laser light scatter technology, impedance method, light absorbance

DHSS technology combining cytochemistry, focused flow impedance, and light absorbance

Analytical measurement range: • WBC count/RBC count 0.95–83.45/0.44–7.74 0.2–100/0.36–7.19 0–120 (120–360 with CDR)/0–8

• Hemoglobin/Platelet 1.4–23.7/11–975 1.1–22.2/15–2,000 0–24/0–1,900; 1,900–3,800, Hb >2 g/dL with CDR

• MCV (fL) or Hct (%) — — 0–67 (Hct) • Reticulocytes — — 0–42%

Precision: • WBC count/RBC count <2.7%/<1.7% <2.7%/<1.7% <2%/<2%

• Hemoglobin/Platelet <2.0%/<6% <2.0%/<6% <1%/<5%

• MCV or Hct <1.7% <1.7% <2% (Hct)


— — —

Interfering substances: • WBC >5 NRBCs/100 WBCs, PLT clumps/large PLTs >5 NRBCs/100 WBCs, PLT clumps/large PLTs NRBCs, PLT clumps, lyse-resistant RBCs

• RBC WBC count >50.0 × 103/µL WBC count >75.0 × 103/µL cold agglutinins • MCV or Hct WBC count >50.0 × 103/µL WBC count >75.0 × 103/µL Hct: extreme leukocytosis

• Platelet PLT clumps/large PLTs PLT clumps/large PLTs microcytes, PLT clumps

• Hemoglobin WBC count >50.0 × 103/µL, lipids >270 mg/dL WBC count >75.0 × 103/µL, lipids >280 mg/dL extreme lipemia, leukocytosis

Interfering substances: differential >5 NRBCs/100 WBCs, PLT clumps/large PLTs >5 NRBCs/100 WBCs, PLT clumps/large PLTs NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia

Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 60/60 80/80

Minimum specimen volume open/Closed/Sample dead volume closed 100 µL/100 µL/— 110 µL/110 µL/— 30 µL for CBC and 53 µL for CBC and differential/ 100 µL/—

Microsample capability no no yes

Prepares microscope slides automatically or flags problems for slide prep no no noNumber of automatic slidemakers available/List price — — —

Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/noMaximum archived data accessible when system online 10,000 results 100,000 results 100,000No. specimens for which numeric results saved in memory at once 10,000 results 100,000 results unlimited with backupNo. specimens for which histo/cytogram results saved in memory at once 10,000 results 100,000 results unlimited with backupPerforms delta checks no no yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor yes yes yesScattergram display: cell-specific color no yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information no no no

LIS interface formats supported HL7, Diatron Serial Communication HL7, Diatron Serial Protocol proprietary, ASTM 1394Information transferred on LIS interface numeric and flag results, histograms and scatterplots,

instrument to LIS; patient demographics, orders, LIS to instrument—broadcast

histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, patient orders, LIS to instrument—broadcast; host query for patient demographics and orders


no/no/no no/no/no no/no/no

Interface available or planned to automated specimen-handling system none none noBarcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5

Accommodates barcode placement per CLSI standard AUTO02-A2 — — yes

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/3 1/3 2/6

Time required for daily, weekly, monthly maintenance daily: 10 minutes; weekly: 15 minutes; monthly: 10 minutes daily: 10 minutes; weekly: 15 minutes; monthly: 10 minutes

daily: 10 minutes; weekly: 15 minutes; monthly: 15 minutes

Onboard diagnostics for troubleshooting/Limited to software problems no/no no/no yes/yes

Manufacturer can perform diagnostics via modem no no no



reliable 3-part diff analyzers with two sampling modes: cap-piercing mode for closed-tube sampling and another for open tubes; operator safety: self-cleaning procedures minimize daily maintenance; user-friendly and easy-to-operate high-resolution touchscreen; USB and barcode option to load QC target values; capable to read QR codes for reference input data; confidence: system uses easy-to-understand warning messages and sample flags, employs a comprehensive QC SW package

compact, benchtop 5-part laser WBC differential analyzer provides accurate and precise results; two sampling modes (cap-piercing mode for closed-tube sampling and another for open tubes); field upgradeable with optional autosampler with built-in barcode reader, sample capacity: 100 tubes; user friendly and easy to operate: easy-to-follow, intuitive icon user interface

customized dilution ratio for over range WBC up to 360 × 103/mm3 and platelet up to 5,600 x 103/mm3; auto-rerun of patient results based on customized criteria; autovalidation of patient results on customized criteria




Part 6 of 13


HORIBA Medical HORIBA Medical MindrayJim Knowles [email protected] Jim Knowles [email protected] Peggy Chan [email protected], CA Irvine, CA Redmond, WA888-903-5001 ext. 4553 www.horiba.com/us/en/medical 888-903-5001 ext. 4553 www.horiba.com/us/en/medical 425-881-0361 ext. 3305 www.mindraynorthamerica.com

Name of instrument Pentra 60C+ Hematology Analyzer Pentra XL 80 BC-5390First year installed in U.S./Outside U.S./No. of units sold in 2017 2000/2000/85 2004/2003/31 2016/2012/—No. units installed in U.S./Outside U.S./List price >350/>600/$47,313 >250/>900/$76,808 24/1,612/—


standard menu (left) plus: RDW, MPV standard menu (left) plus: automatic dilution of over-range results (WBC × 3, RBC/Hgb/PLT × 2), RDW, MPV

standard menu (left) plus: RDW-CV, RDW-SD, MPV, mono %&#, lymph %&#, eos %&#, baso %&#

• Laboratory atypical lymphocytes, atypical lymphocytes %, LIC, LIC% atypical lymphocytes, atypical lymphocytes %, LIC, LIC% — • Flags operator selectable flagging operator selectable flagging WBC scattergram abn., WBC histogram abn., blast,

immature gran, left shift, abn./atypical lym, RBC lyse resist, NRBC, dimorphic population, turb/HGB interference, RBC agglutination, PLT histogram abn., PLT clump

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only PCT, PDW, ATL, LIC PCT, PDW, ATL, LIC —Tests unique to analyzer — automatic dilution protocol —

Differential method(s) used DHSS technology combining cytochemistry, focused flow impedance, and light absorbance principles of measurement

DHSS technology combining cytochemistry, focused flow impedance, and light absorbance

flow cytometry, light scatter

Analytical measurement range: • WBC count/RBC count 0–120/0–8 0–120/0–8 0.3–200/0.2–8.0 • Hemoglobin/Platelet 0–24/0–1,900 0–24/0–1,900 (>2 g/dL Hb) 0.5–25/5–2,000

• MCV (fL) or Hct (%) 0–67 (Hct) 0–67 (Hct)/0–2,800 (<2 g/dL Hb) 2–75 (Hct%)

• Reticulocytes — — —

Precision: • WBC count/RBC count <2%/<2% <2%/<2% <0.15 (SD) or 3.0% (CV)/<1.5% • Hemoglobin/Platelet <1%/<5% <1%/<5% <1.5%/<7.5 (SD) or 5% (CV) • MCV or Hct <2% (Hct) <2% (Hct) <1.5% (MCV)


neut% r=0.99, lymph% r=0.98, mono% r=0.96, eos% r=0.89, baso% r=0.54

neut% r=0.99, lymph% r=0.98, mono% r=0.96, eos% r=0.89, baso% r=0.54

neu%: ±5.00 or ±10.0%; lym%: ±4.00 or ±10.0%; mon%: ±3.00 or ±10.0%; eos%: ±2.00 or ±10.0%; bas%: ±1.00 or ±10.0%

Interfering substances: • WBC NRBCs, PLT clumps, lyse-resistant RBCs NRBCs, PLT clumps, lyse-resistant RBCs platelet aggregation, lyse-resistant erythrocytes, erythroblasts, cold agglutinin, cryoglobulin, giant platelets, lipemia, chylomicronemia

• RBC cold agglutinins cold agglutinins cold agglutinin, fragmented erythrocytes, leukocytosis, giant platelets

• MCV or Hct Hct: extreme leukocytosis Hct: extreme leukocytosis RBC fragments, very high WBC count, high concentration of very large platelets, microclots, RBC rouleaux or agglutinates (autoagglutination)

• Platelet microcytes, PLT clumps microcytes, PLT clumps PLT aggregation or PLT satellitism, giant platelets, microcytosis, fragmented erythrocytes

• Hemoglobin extreme lipemia, leukocytosis extreme lipemia, leukocytosis leukocytosis, lipemia, chylomicronemia, abnormal protein

Interfering substances: differential NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia NRBCs, lyse-resistant RBCs, extreme hyperbilirubinemia lysis-resistant RBC, NRBC, PLT aggregates, giant PLT

Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 80/80 60/60Minimum specimen volume open/Closed/Sample dead volume closed 30 µL for CBC and 53 µL for CBC and differential/30 µL

for CBC and 53 µL for CBC and differential/—30 µL for CBC/53 µL for CBC and differential/0.5 mL —/33 µL, predilute 20 µL/1 mL

Microsample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep yes yes noNumber of automatic slidemakers available/List price — — —

Archives patient data/Previous patient results incl. with recent results yes/yes, with MultiLink Data Manager yes/yes, with MultiLink Data Manager yes/yesMaximum archived data accessible when system online 100,000 100,000 100,000No. specimens for which numeric results saved in memory at once unlimited with backup unlimited with backup 100,000No. specimens for which histo/cytogram results saved in memory at once unlimited with backup unlimited with backup 100,000Performs delta checks yes yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor user user yesScattergram display: cell-specific color yes yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes — yes

LIS interface formats supported ASTM 1394 and 1238, HL7, IEEE MIB proprietary, ASTM 1394 and 1238, HL7, IEEE MIB HL7

Information transferred on LIS interface numeric and flag results, histograms and scatter-plots, instrument to LIS; patient demographics, LIS to instrument—broadcast

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast



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

Interface available or planned to automated specimen-handling system no yes noneBarcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39, 93, and 128, Interleaved 2 of 5, UPC/EANAccommodates barcode placement per CLSI standard AUTO02-A2 yes yes yes

No. of cleaning or maintenance reagents/No. of routine liquid reagents 2/5 2/5 1/4

Time required for daily, weekly, monthly maintenance daily: 10 minutes; weekly: 15 minutes; monthly: 15 minutes

daily: 10 minutes; weekly: 15 minutes; monthly: 15 minutes

daily: <10 minutes

Onboard diagnostics for troubleshooting/Limited to software problems yes/yes no/yes yes/noManufacturer can perform diagnostics via modem yes, with Data Manager no yes



reliable 5-part WBC differential technology; mean time between failures more than 200 days; small footprint; small sample size of 53 µL

compact 5-part differential instrument with auto-loader and autodilution capability, auto rerun feature, autovalidation

60 QC files, maximum 40 samples autoloader capacity, sample adaptors for pediatric and predilution samples, operation software with built-in data-management functions, 3 modes of operation: autoloader and opened and closed tube; customizable patient reports, only 1 maintenance reagent, other maintenance is touch-button operation, cyanide-free, nontoxic reagent; patented WBC differential and digital sheath flow technology, top instrument reliability, mean time between failures >2 years of instrument in the same 5-part series




Part 7 of 13


Mindray Roche Diagnostics Siemens HealthineersPeggy Chan [email protected] Krista Curcio [email protected] David Metrena [email protected], WA Indianapolis, IN Hoffman Estates, IL425-881-0361 ext. 3305 www.mindraynorthamerica.com 317-217-0801 www.roche.com 800-948-3234 www.usa.siemens.com/diagnostics

Name of instrument BC-3600 cobas m 511 integrated hematology analyzer Advia 120 Hematology SystemFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2015/2011/— —/2017/— 1998/1998/—No. units installed in U.S./Outside U.S./List price 78/4,120/— —/>5/$400,000 >750/2,700/$169,000–$189,000Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV,

MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso)WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, gran %&#, lymph %&#, mid %&#, MPV, RDW

standard menu (left) plus: NRBC %&#, MPV, RET %&#, HGB-RET, and digital images

standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC %&#, retic %&#, CHr, CHCMr, MCVr; CSF: WBC, RBC, PMN, MN, neut, lymph, mono; cellular Hgb

• Laboratory — — % hypo, hyper, macro, micro; calc. Hb, MPXI; % blast, PMN, MN; large PLT count; RBC fragment count; RBC ghost count; CSF: WBC, RBC, 3-part differential; body fluids: TNC, RBC

• Flags — atypical lymphs, blasts, immature granulocytes, left shift, giant PLT, PLT clumps, <600 cells counted for differential, hemolysis, RBC agglutination

left shift, atyp. lymph, blasts, immature grans, myeloperoxi-dase deficiency, aniso, micro, macro, Hb variation, hypo, hyper, NRBC, RBC fragments, RBC ghost, large PLTs, PLT clumps

FDA-cleared tests not clinically released none — —Tests not available but submitted for 510(k) clearance none — —Tests in development none — IRF, MPC, MPMTests for research use only none — CSF eosTests unique to analyzer none — CHCM, HDW, CHr, CHCMr, MPC, MPM; CSF: WBC, RBC,

MN, PMN, neut, lymph, monoDifferential method(s) used impedance method for WBC, RBC, MCV, RDW, PLT, MPV

and WBC 3-part differential determination, colorimetric method for HGB determination

digital multispectral image analysis perox: peroxidase cytochemistry staining with light scatter and absorption; baso: cytochemistry stripping with 2-angle laser light scatter

Analytical measurement range: • WBC count/RBC count 0.3–99.9/0.20–7.99 0.07–404,800/0.37–8.26 whole blood: WBC 0.02–400/RBC 0–7.0; CSF: WBC 0–5,000/RBC 0–1,500

• Hemoglobin/Platelet 1.0–24.9/10–999 1.1–24.2/9–5,000 0–22.5/5–3,500 • MCV (fL) or Hct (%) — —/3.2–72.2 (Hct) 30–180 (MCV) • Reticulocytes — 0.003–0.63 (#) 0.2–24.5%Precision: • WBC count/RBC count WBC ≥4.0: ≤3.0% CV%; 1.0 ≤WBC ≤2.0: ≤7.0% CV%/

≤2.5% CV%2.72%/1.34% 2.7%/1.2%

• Hemoglobin/Platelet ≤2.0% CV%/PLT ≥150: ≤6.0% CV%; 20 ≤PLT≤ 50: ≤20.0% CV%

1.52%/1.97% 0.93%/2.93%

• MCV or Hct ≤2.0 CV% (MCV), ≤2.5% CV% (Hct) 0.73% (MCV), 1.46% (Hct) 0.78% (MCV)Accuracy of automated differential compared with manual differential (per CLSI H20-A2)

— — neut% r=0.997, y=1.02x–0.6; lymph% r=0.997, y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos% r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0; luc% r=0.994, y=0.92x+0.6

Interfering substances: • WBC certain unusual RBC abnormalities that resist lysing, nucleated RBCs, fragmented WBCs, unlysed particles, very large or aggregated platelets as when anticoagulated with oxalate or heparin

leukocyte aggregation, platelet clumps, giant platelets incomplete RBC lysis (peroxidase only)

• RBC very high WBC count, high concentration of very large platelets, agglutinated RBCs and smaller RBC

erythrocyte aggregation, microerythrocytes, fragmented RBC

cold agglutinins, extreme sickle cell

• MCV or Hct very high WBC count, high concentration of very large platelets, agglutinated RBCs, RBC fragments

Hct: erythrocyte aggregation, microerythrocytes, possibility of fragmented red blood cells

—

• Platelet very small red blood cells near the upper PLT threshold, cell fragments, clumped platelets as with oxalate or heparin, platelet fragments or cellular debris near the lower platelet threshold

platelet clumps, pseudo thrombocytopenia, activated platelets, fragmented leukocytes

—

• Hemoglobin very high WBC count, severe lipemia, certain unusual RBC abnormalities that resist lysing, anything that increases the turbidity of the sample such as elevated levels of triglycerides

erythrocyte aggregation high WBC, lipemia, extremely high bilirubin, interfere with cyanmethemoglobin only, none with direct cellular Hb (CHCM)

Interfering substances: differential known factors that affect the WBC count as listed above, high triglycerides that can affect lysing

— incomplete lysis of RBCs, complete myeloperoxidase deficiency

Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 60/60 (including images of all WBCs, RBCs, and platelets) 120/120Minimum specimen volume open/Closed/Sample dead volume closed 21 µL/21 µL/1 mL 50 µL/480 µL/450 µL 157 µL/157 µL/<300 µL (tube size dependent)Microsample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep no yes yesNumber of automatic slidemakers available/List price — included with system —

Archives patient data/Previous patient results incl. with recent results no/no yes/yes yes/noMaximum archived data accessible when system online — abnormal images maintained for 2 years, numeric data

for ~10 years; normal images stored for up to 30 days10,000 samples

No. specimens for which numeric results saved in memory at once 40,000 numeric data stored for ~10 years 10,000 samplesNo. specimens for which histo/cytogram results saved in memory at once 40,000 normal sample images stored for up to 30 days; abnormal

images maintained for 2 years; numeric data stored ~10 years10,000 samples

Performs delta checks no yes yesTags and holds results for follow-up, confirmatory testing, or rerun no yes yesParameters for flags for holding samples defined by user or vendor no yes user or vendorScattergram display: cell-specific color no cell images are displayed instead of scattergrams yesHistogram display: color with thresholds yes yes (view specific cell’s location within the PLT or RBC

histogram)yes

User interface can display choice of specimen or result information no yes yesLIS interface formats supported HL7 ASTM proprietary (Spec 79) Information transferred on LIS interface numeric and flag results, instrument to LIS; patient

demographics, orders, LIS to instrument—broadcastresults, flags/messages, QC numeric and flag results, histograms and scatterplots,

instrument to LIS; patient demographics, orders, LIS to instru-ment—broadcast; host query for demographics and orders


yes/yes/no — no/no/yes

Interface available or planned to automated specimen-handling system — — LabCell (Siemens)Barcode symbologies read on specimen tube Codabar, codes 39 and 128 codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Accommodates barcode placement per CLSI standard AUTO02-A2 no yes yes

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/4 2/2 1/7Time required for daily, weekly, monthly maintenance daily: <10 minutes daily: <5 minutes daily: automated; weekly: 15 minutes; monthly: 15 minutesOnboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem no yes yesDistinguishing features (supplied by company)


10.4-inch all-in-one Glance color touchscreen, touch-button maintenance procedures, and low sample requirement; 40,000 patient results storage, close-tube sampling, open-tube sampling for pediatric samples, 3 types of sample adaptors, barcoded reagent, and 5 minutes daily start-up and maintenance; 12 QC files, uploadable QC files, auto-sleep setting, only 1 maintenance reagent, and sample stability between 8 and 24 hours

all CBC parameters are determined using multispectral digital image analysis directly from a prepared, stained slide; WBC differential performed using digital cell image analysis on every sample; combines 3 separate processes (CBC/differential, slide making/staining, slide review) into 1 truly integrated system

laser technology provides cellular Hb for RBCs and reticulocytes; 2D PLT analysis eliminates interference from RBC fragments and inclusion of large PLTs; dual WBC counts with a linearity of up to 400,000; CSF assay




Part 8 of 13


Siemens Healthineers Siemens Healthineers Siemens HealthineersDavid Metrena [email protected] David Metrena [email protected] David Metrena [email protected] Estates, IL Hoffman Estates, IL Hoffman Estates, IL800-948-3234 www.usa.siemens.com/diagnostics 800-948-3234 www.usa.siemens.com/diagnostics 800-948-3234 www.usa.siemens.com/diagnostics

Name of instrument Advia 2120 Hematology System Advia 2120i Advia 360 Hematology SystemFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2004/2004/— 2008/2008/130 2015/2015/—No. units installed in U.S./Outside U.S./List price >200/>3,700/$225,000 >200/>3,700/$225,000 —/—/$24,000


standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC %&#, retic %&#, CHr, CHCMr, cellular Hgb, MCVr; CSF: WBC, RBC, PMN, MN, neut, lymph, mono

standard menu (left) plus: CHCM, MPV, RDW, HDW, LUC %&#, retic %&#, CHr, CHCMr, cellular Hgb, MCVr; CSF: WBC, RBC, PMN, MN, neut, lymph, mono

WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, lymph, MID, GRA, MID%, GRA%, MPV, RDW-CV

• Laboratory % hypo, hyper, macro, micro; MPXI; % blast, PMN, MN, large PLT count, RBC fragment count; RBC ghost count; NRBC; CSF: WBC, RBC, 3-part differential; body fluids: TNC, RBC

% hypo, hyper, macro, micro, MPXI; % blast, PMN, MN, large PLT count, RBC fragment count, RBC ghost count, NRBC; CSF: WBC, RBC, 3-part differential; body fluids: TNC, RBC

—

• Flags left shift, atyp. lymph, blasts, immature grans, myeloperoxidase deficiency, aniso, micro, macro, Hb variation, hypo, hyper, NRBC, RBC fragments, RBC ghost, large PLTs, PLT clumps

left shift, atypical lymphocytes, blasts, immature grans, myeloperoxidase deficiency, aniso, micro, macro, Hgb variation, hypo, hyper, NRBC, RBC fragments, RBC ghost, large PLTs, PLT clumps

out-of-range flags, measurement condition flags (warnings); flagging on WBC and HGB channels; flagging on RBC/PLT channel; warning flags of differential parameters

FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —

Tests in development MPC, MPM MPC, MPM —

Tests for research use only IRF, CSF eos IRF, CSF eos —

Tests unique to analyzer CHCM, HDW, CHr, CHCMr, cellular Hgb, MPC, MPM; CSF: WBC, RBC, PMN, MN, neut, lymph, mono

CHCM, HDW, CHr, CHCMr, cellular Hgb, MPC, MPM; CSF: WBC, RBC, PMN, MN, neut, lymph, mono

—

Differential method(s) used peroxidase WBC: peroxidase cytochem. staining with light scatter and absorption; baso: cytochem. stripping with 2-angle laser light scatter

peroxidase WBC: peroxidase cytochem. staining with light scatter and absorption; baso: cytochem. stripping with 2-angle laser light scatter

volumetric impedance change for WBC, RBC, PLT; lytic reagents with impedance method for 3 subpopulations; spectrophotometry for HGB

Analytical measurement range: • WBC count/RBC count whole blood: WBC 0.02–400/RBC 0–7.0; CSF: WBC 0–5,000/RBC 0–1,500

whole blood: WBC 0.02–400/RBC 0–7.0; CSF: WBC 0–5,000/RBC 0–1,500

0.0–85.0/0.00–8.00

• Hemoglobin/Platelet 0–22.5/5–3,500 0–22.5/5–3,500 1.0–25.0/0–1,000

• MCV (fL) or Hct (%) 30–180 (MCV) 30–180 (MCV) 50–120 (MCV)

• Reticulocytes 0.2–24.5% 0.2–24.5% —

Precision: • WBC count/RBC count 2.7%/1.2% 2.7%/1.2% <4.0%/<2.5%

• Hemoglobin/Platelet 0.93%/2.93% 0.93%/2.93% <2.4%/<7.0%

• MCV or Hct 0.78% (MCV) 0.78% (MCV) <2.0% (MCV)


neut% r=0.997, y=1.02x–0.6; lymph% r=0.997, y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos% r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0; luc% r=0.994, y=0.92x+0.6

neut% r=0.997, y=1.02x-0.6; lymph% r=0.997, y=1.00x+0.8; mono% r=0.943, y=0.85x–0.3; eos% r=0.979, y=0.87x+0.2; baso% r=0.772, y=0.67x+0.0; luc% r=0.994, y=0.92+0.6

—

Interfering substances: • WBC incomplete RBC lysis (peroxidase only) incomplete RBC lysis (peroxidase only) >5 NRBCs/100 WBCs, PLT clumps/large PLTs

• RBC cold agglutinins, extreme sickle cell cold agglutinins, extreme sickle cell WBC count >50.0 × 103/µL

• MCV or Hct — — WBC count >50.0 × 103/µL

• Platelet — — PLT clumps/large PLTs (abnormal histogram)

• Hemoglobin extreme lipemia, high WBC, extremely high bilirubin interference with colorimetric Hb only, none with cellular Hb

extreme lipemia, high WBC, extremely high bilirubin interference with colorimetric Hgb only, none with cellular Hgb

WBC count >50.0 × 103/µL, lipids >270 mg/dL

Interfering substances: differential incomplete RBC lysis, complete myeloperoxidase deficiency

incomplete RBC lysis, complete myeloperoxidase deficiency

> 5 NRBCs/100 WBCs, PLT clumps/large PLTs (abnormal histogram)

Maximum CBCs per hour/Maximum CBCs and differentials per hour 120/120 120/120 60/60Minimum specimen volume open/Closed/Sample dead volume closed 175 µL/175 µL/<300 (tube size dependent) 175 µL/175 µL/<300 (tube size dependent) 100 µL/100 µL/—Microsample capability yes yes —Prepares microscope slides automatically or flags problems for slide prep if integrated to Advia Autoslide yes noNumber of automatic slidemakers available/List price Advia Autoslide/$98,000 Advia Autoslide/$98,000 —

Archives patient data/Previous patient results incl. with recent results yes/no yes/no yes/noMaximum archived data accessible when system online 10,000 10,000 samples 10,000

No. specimens for which numeric results saved in memory at once 10,000 10,000 samples 10,000No. specimens for which histo/cytogram results saved in memory at once 10,000 10,000 samples 10,000

Performs delta checks yes yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor user or vendor yes yesScattergram display: cell-specific color yes yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported proprietary proprietary (instrument or vendor specific) proprietary, HL7Information transferred on LIS interface numeric and flag results, histograms and scatterplots,

instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders




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

Interface available or planned to automated specimen-handling system LabCell (Siemens) LabCell (Siemens) noneBarcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5Accommodates barcode placement per CLSI standard AUTO02-A2 — yes —

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/7 1/7 1/4Time required for daily, weekly, monthly maintenance daily: automated; weekly: 15 minutes;

monthly: 15 minutesdaily: automated; weekly: 15 minutes; monthly: 15 minutes

daily: 5 minutes; weekly: 20 minutes

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/—Manufacturer can perform diagnostics via modem yes yes no



laser technology provides direct cellular Hb for RBCs and reticulocytes; 2D PLT analysis eliminates interference from RBC fragments and inclusion of large PLTs; dual WBC counts with a linearity of up to 400,000; CSF assay

laser technology provides direct cellular Hgb for RBCs and reticulocytes; 2D PLT analysis eliminates interference from RBC fragments and inclusion of large PLTs; dual WBC counts with a linearity of up to 400,000; CSF assay

measures 16 parameters including 3-part WBC differential; efficient manual sampling of both open and closed tubes; 60 samples per hour, volume as low as 100 µL




Part 9 of 13


Siemens Healthineers Sysmex America Sysmex AmericaDavid Metrena [email protected] Jennifer Starks [email protected] Kevin Croghan [email protected] Estates, IL Lincolnshire, IL Lincolnshire, IL800-948-3234 www.usa.siemens.com/diagnostics 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us

Name of instrument Advia 560/560AL Hematology GloCyte Automated Cell Counter for CSF* pocH-100iFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2015/2015/— 2016/—/26 2004/2003/>160No. units installed in U.S./Outside U.S./List price —/—/$56,800 24/—/$9,985 >1,200/>5,000/$19,094


WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso, LYM%, MON%, EOS%, BAS%, RDW-CV, MPV

RBC, TNC WBC, RBCs, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, lymph, MXD (mono, eos, baso), RDW-SD, RDW-CV, MPV

• Laboratory — — —

• Flags pathological (diagnostic) flags; lab limits (normal ranges); reagents alert (3 measurement pre-alert online reagent replacement); instrumental alerts, internal buffer for reagents

— WBC, RBC, PLT (histogram)

FDA-cleared tests not clinically released — — —

Tests not available but submitted for 510(k) clearance — — —

Tests in development — — —

Tests for research use only — — —

Tests unique to analyzer — — absolute neutrophil count

Differential method(s) used volumetric impedance change for WBC, RBC, PLT; light scattering baso measurement; light scattering 4-diff measurement LYM, MON, NEU, EOS; spectrophotometry for HGB

— direct current

Analytical measurement range: • WBC count/RBC count 0.20–100.0/0.36–7.19 TNC: 3–123 cells/µL reportable range 3–6,500 cells/µL/ 2–123 cells/µL reportable range 2–615,644 cells/µL

1.0–99.9/0.3–7.0

• Hemoglobin/Platelet 1.10–22.2/15.0–1,000 — 0.1–25.0/10–999 • MCV (fL) or Hct (%) 50–120 (MCV) — 10–60 (Hct) • Reticulocytes — — —

Precision: • WBC count/RBC count <3.4%/<2.0% TNC: 2.5–18.0% repeatability CV/2.7–16.3% repeatability CV

≤3.5%/≤2.0%

• Hemoglobin/Platelet <2.4%/<7.0% — ≤1.5%/≤6.0% • MCV or Hct <2.0% (MCV) — ≤2.0% (Hct)


— — neut% r=0.98, lymph% r=0.99, MXD% r=0.75, neut# r=1.00, lymph# r=1.00, MXD# r=0.90

Interfering substances: • WBC >5 NRBCs/100 WBCs, PLT clumps/large PLTs TNC: nucleated RBCs lyse-resistant RBCs, cold agglutinins, cryoglobulins, PLT aggregation, NRBCs

• RBC WBC count >75.0 × 103/µL — cold agglutinins, severe microcytosis, fragmented RBCs

• MCV or Hct WBC count >75.0 × 103/µL — cold agglutinins, fragmented RBCs, leukocytosis (>100,000/µL)

• Platelet PLT clumps/large PLTs — PLT aggregation, giant PLTs, microcytic RBCs, fragmented RBCs

• Hemoglobin WBC count >75.0 × 103/µL, lipids >280 mg/dL — severe lipemia, abnormal protein, leukocytosis (>100,000/µL)

Interfering substances: differential > 5 NRBCs/100 WBCs, PLT clumps/large PLTs — —

Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 CSFs: ~12/— 30/30Minimum specimen volume open/Closed/Sample dead volume closed 100 µL/100 µL/— 60 µL/—/— 15 µL/15 µL/15 µLMicrosample capability — no yesPrepares microscope slides automatically or flags problems for slide prep no no noNumber of automatic slidemakers available/List price — — —

Archives patient data/Previous patient results incl. with recent results yes/no no/no yes/yesMaximum archived data accessible when system online 100,000 — 100 samplesNo. specimens for which numeric results saved in memory at once 100,000 1,600 per database 100 samplesNo. specimens for which histo/cytogram results saved in memory at once 100,000 — 100 samplesPerforms delta checks yes no yesTags and holds results for follow-up, confirmatory testing, or rerun yes no noParameters for flags for holding samples defined by user or vendor yes no yesScattergram display: cell-specific color yes no noHistogram display: color with thresholds yes no yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported proprietary, HL7 RS232, bidirectional RS-232C

Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders

numeric and flag results, instrument to LIS; patient, orders, LIS to instrument—broadcast

numeric and flag results, histograms and scatterplots, patient demographics, orders, host query for patient demographics and orders


yes/yes/yes yes/—/— no/no/yes

Interface available or planned to automated specimen-handling system none none —Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ASTM, Interleaved 2 of 5 Codabar, codes 39 and 128, Interleaved 2 of 5, Data

Matrixcodes 39 and 128, ASTM, ITF, NW7, JAN-8 and 13

Accommodates barcode placement per CLSI standard AUTO02-A2 — yes yes

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/4 0/2 (RBC and TNC reagents) 1/2

Time required for daily, weekly, monthly maintenance daily: 5 minutes; weekly: 20 minutes change O-ring on vacuum every six months daily: <2 minutes; weekly: <2 minutes; monthly: <2 minutes

Onboard diagnostics for troubleshooting/Limited to software problems — yes/yes yes/noManufacturer can perform diagnostics via modem no no yes



60 samples per hour, volume as low as 110 µL; measures 20 parameters and employs laser-based optical measurement to provide a 5-part WBC differential; aids in interpreting disease state information with 2 scattergrams and 2 histograms per result

1 cell/µL limit of detection for both RBC and TNC; consistent turnaround time for standarization and for lean practices; disposable test cartridges eliminate carryover for infectious samples

*Sysmex America is the exclusive distributor of GloCyte in the United States.

hydrodynamic focusing, automatic floating discriminators, ISBT-compliant, data-masking software for blood donor centers; optional upgrade to pocHi Plus or pocHi Linc available (data manager and small LIS); ability to directly link to EMR




Part 10 of 13


Sysmex America Sysmex America Sysmex AmericaAnn Ludwig [email protected] Ann Ludwig [email protected] Ann Ludwig [email protected], IL Lincolnshire, IL Lincolnshire, IL800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us

Name of instrument XN-1000 XN-2000 XN-3100First year installed in U.S./Outside U.S./No. of units sold in 2017 2012/2011/>390 2012/2011/>180 2017/2017/—No. units installed in U.S./Outside U.S./List price >700/>450/$202,667 >500/>450/$402,667 <10/<10/$562,667


standard menu (left) plus: NRBC %&#, IG %&#, MPV, PLT-F, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He; body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&#



• Laboratory — — — • Flags blasts/abnormal lymphocytes, left shift, atypical

lymphocytes, RBC agglutination, turbidity/HGB interference, iron deficiency, HGB defect, fragments, PLT clumps

blasts/abnormal lymphocytes, left shift, atypical lymphocytes, RBC agglutination, turbidity/HGB interference, iron deficiency, HGB defect, fragments, PLT clumps


FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — — —Tests unique to analyzer IG %&#, PLT-F, IPF, RET-He; body fluids: two-part

differential MN %&#, PMN %&#IG %&#, PLT-F, IPF, RET-He; body fluids: two-part differential MN %&#, PMN %&#

IG %&#, PLT-F, IPF, RET-He; body fluids: two-part differential MN %&#, PMN %&#

Differential method(s) used fluorescent flow cytometry with side fluorescent light, forward-scattered and side-scattered light

fluorescent flow cytometry with side fluorescent light, forward-scattered and side-scattered light


Analytical measurement range: • WBC count/RBC count 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 • Hemoglobin/Platelet 0.0–26.0/0–5,000 0.0–26.0/0–5,000 0.0–26.0/0–5,000 • MCV (fL) or Hct (%) 0.0–75.0% (Hct) 0.0–75.0% (Hct) 0.0–75.0% (Hct) • Reticulocytes 0.00–30.00 0.00–30.00 0.00–30.00

Precision: • WBC count/RBC count <3.0%/<1.5% <3.0%/<1.5% <3.0%/<1.5% • Hemoglobin/Platelet <1.0%/<4.0% <1.0%/<4.0% <1.0%/<4.0% • MCV or Hct <1.5% (Hct) <1.5% (Hct) <1.5% (Hct)


— — —

Interfering substances: • WBC no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 30.320 OD for intralipid, 2,880 OD for chyle

no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 30.320 OD for intralipid, 2,880 OD for chyle


• RBC no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• MCV or Hct no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• Platelet no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• Hemoglobin no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis

no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis


Interfering substances: differential — — —

Maximum CBCs per hour/Maximum CBCs and differentials per hour 100/100 200/200 varies by configuration/varies by configurationMinimum specimen volume open/Closed/Sample dead volume closed 88 µL/88 µL/1 mL 88 µL/88 µL/1 mL 88 µL/88 µL/1 mLMicrosample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep yes yes yesNumber of automatic slidemakers available/List price — — 1/included

Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes yes/yesMaximum archived data accessible when system online 100,000 100,000 100,000No. specimens for which numeric results saved in memory at once 100,000 100,000 100,000No. specimens for which histo/cytogram results saved in memory at once 100,000 100,000 100,000Performs delta checks yes yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor yes yes yesScattergram display: cell-specific color yes yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-02/ASTM1894-97

XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-02/ASTM1894-97


Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for demographics and orders

numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for demographics and orders



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

Interface available or planned to automated specimen-handling system none none none

Barcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/EAN/UPC

Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/EAN/UPC



No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/5 cubitainer reagents, 4 fluorescent dye cartridges 1/5 cubitainer reagents, 4 fluorescent dye cartridges 1/5 cubitainer reagents, 4 fluorescent dye cartridgesTime required for daily, weekly, monthly maintenance daily: <1 minute (operator time) daily: <1 minute (operator time) <3 minutes (operator time), ~15 minutes (analyzer time)

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem yes yes yes



reportable parameters include IG %&#, RET-He, fluorescent PLT, body fluid with 2-part differential; onboard preloaded decision rules including automated rerun-reflex capabilities; optional wagons for complete reagent management; compatible with MySysmex, an easy-to-use mobile assistant that displays real-time analyzer performance data, enabling informed decision-making; compatible with optional RU-20 reagent unit that allows for use of concentrated Cellpack

fully integrated co-primary hematology solution consisting of 2 analytical modules connected with a single sampler, providing maximum productivity and efficiency with workload balancing; reportable parameters include IG %&#, RET-He, fluorescent PLT, body fluid with 2-part differential, onboard preloaded decision rules including automated rerun-reflex capabilities; optional wagons for complete reagent management; compatible with MySysmex, an easy-to-use mobile assistant that displays real-time analyzer performance data, enabling informed decision-making; compatible with optional RU-20 reagent unit that allows for use of concentrated Cellpack

co-primary hematology solution: 2 analytical modules plus a fully integrated 5th generation slidemaker/stainer (SP-50); integration of the DI-60 automated cell image system providing preclassification for WBC, RBC, and PLT estimates; compatible with optional RU-20 reagent unit that allows for use of concentrated Cellpack; optional configuration (XN-20) possesses the white cell precursor channel (WPC). It uses this channel to differentiate a single flag—blast/abnormal lymphocytes—into 2 distinct flags: blasts and abnormal lymphocytes




Part 11 of 13


Sysmex America Sysmex America Sysmex AmericaAnn Ludwig [email protected] Kanochia Johnson [email protected] Ann Ludwig [email protected], IL Lincolnshire, IL Lincolnshire, IL800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us

Name of instrument XN-9100 XN-1000V* XN-1000 RFirst year installed in U.S./Outside U.S./No. of units sold in 2017 2017/2017/— 2017/2017/— 2014/2015/>105No. units installed in U.S./Outside U.S./List price <10/<10/varies based on configuration —/—/$227,667 >200/>250/$147,795



WBC, RBC, Hb, Hct, MCV, MCH, PLT, %&# neut, mono, lymph, eos, baso, NRBC %&#, MPV, PLT-F, PLT-O, IPF, RDW-CV, RDW-SD, retic %&#, IRF, RET-He; body fluids: RBC-BF, TC-BF, WBC-BF, MN %&#, PMN %&#

standard menu (left) plus: NRBC %&#, IG %&#, MPV, RDW-CV, RDW-SD, retic %&#, IRF, RET-He

• Laboratory — — — • Flags blasts/abnormal lymphocytes, left shift, atypical




FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — not FDA cleared for human use; for research use only —Tests unique to analyzer IG %&#, PLT-F, IPF, RET-He; body fluids: 2-part

differential MN %&#, PMN %&#PLT-F, PLT-O, IPF, RET-He; body fluids: 2-part differential MN %&#, PMN %&#

IG %&#, RET-He

Differential method(s) used fluorescent flow cytometry with side fluorescent light, forward-scattered and side-scattered light


fluorescent flow cytometry with side fluorescent light, forward-scattered light, and side-scattered light

Analytical measurement range: • WBC count/RBC count 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 0–440/0–8.6 • Hemoglobin/Platelet 0.0–26.0/0–5,000 0.0–26.0/0–5,000 0–26/0–5,000 • MCV (fL) or Hct (%) 0.0–75.0% (Hct) 0.0–75.0% (Hct) 0–75 (Hct) • Reticulocytes 0.00–30.00 — 0.00–30.00

Precision: • WBC count/RBC count <3.0%/<1.5% <3.0%/<1.5% ≤3%/≤1.5% • Hemoglobin/Platelet <1.0%/<4.0% <1.0%/<4.0% ≤1.0%/≤4.0% • MCV or Hct <1.5% (Hct) <1.5% (Hct) ≤1.5% (Hct)


— — —

Interfering substances: • WBC no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 30.320 OD for intralipid, 2,880 OD for chyle



• RBC no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• MCV or Hct no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• Platelet no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 996 mg/dL for hemolysis, 55.980 OD for intralipid, 2,880 OD for chyle



• Hemoglobin no significant interference up to: 39.4 mg/dL for bilirubin C, 37.4 mg/dL for bilirubin F, 199 mg/dL for hemolysis




Maximum CBCs per hour/Maximum CBCs and differentials per hour >100, varies by configuration/>100, varies by configuration 100/100 100/100Minimum specimen volume open/Closed/Sample dead volume closed 88 µL/88 µL/1 mL 88 µL/88 µL/1 mL 88 µL/88 µL/1 mLMicrosample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep yes yes yesNumber of automatic slidemakers available/List price configurable/included — >1,000/—

Archives patient data/Previous patient results incl. with recent results yes/yes yes/yes yes/yesMaximum archived data accessible when system online 100,000 30,000 100,000 samplesNo. specimens for which numeric results saved in memory at once 100,000 30,000 100,000 samplesNo. specimens for which histo/cytogram results saved in memory at once 100,000 30,000 100,000 samplesPerforms delta checks yes yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor yes yes user or vendorScattergram display: cell-specific color yes yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-02/ASTM1894-97

proprietary, XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-02/ASTM1894-97


Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for demographics and orders




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

Interface available or planned to automated specimen-handling system Abbott, Ortho Clinical, Roche, Siemens none noneBarcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/

EAN/UPCCodabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/EAN/UPC



No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/5 cubitainer reagents, 4 fluorescent dye cartridges — 1/5 cubitainer reagents, 4 fluorescent dye cartridgesTime required for daily, weekly, monthly maintenance <3 minutes (operator time), ~15 minutes (analyzer time) daily: <1 minute (operator time) —Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/—Manufacturer can perform diagnostics via modem yes yes yes



scalable, modular system that can be configured as an island of automation or connected to TLA systems; integration of the DI-60 automated cell image system providing preclassification for WBC, RBC, and PLT estimates; tube sorter/archiver (TS-10) and A1c testing (Bio-Rad Variant II Turbo Link) provide complete testing efficiencies; optional configuration (XN-20) possesses the white cell precursor channel (WPC). It uses this channel to differentiate a single flag—blast/abnormal lymphocytes—into 2 distinct flags: blasts and abnormal lymphocytes

customizable, manual gating, low maintenance, remote diagnostics, online QC, fluorescent optical platelets; discrete testing, reagent monitoring, customized chartable report formats; for use in toxicology, research, and veterinary reference labs

*XN-1000V is not FDA cleared for human use; for research use only.

optional testing licenses/capabilities: body fluid license that includes reportable WBC, RBC, total nucleated count, and 2-part differential, fluorescent PLT-F with reportable immature platelet fraction (IPF); optional accessory wagon for complete reagent management; onboard, preloaded decision rules to help manage rerun/reflex testing; compatible with MySysmex, an easy-to-use mobile assistant that displays real-time analyzer performance data, enabling informed decision-making; compatible with optional RU-20 reagent unit that allows for use of concentrated Cellpack




Part 12 of 13


Sysmex America Sysmex America Sysmex AmericaKevin Croghan [email protected] Carl Trippiedi [email protected] Carl Trippiedi [email protected], IL Lincolnshire, IL Lincolnshire, IL800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us 800-379-7639 www.sysmex.com/us

Name of instrument XP-300 XN-350, XN-450, XN-550 (XN-L Series) XN-330, XN-430 (XN-L Series)First year installed in U.S./Outside U.S./No. of units sold in 2017 2013/2012/>250 2017/2015/— 2017/—/—No. units installed in U.S./Outside U.S./List price >700/>2,000/$28,408 —/—/$75,000–$110,000 —/—/$71,000–$84,000


WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, lymph, MXD %&# (mono, eos, baso)

standard menu (left) plus: IG %&#, MPV, RDW-CV, RDW-SD

standard menu (left) plus: IG %&#, MPV, RDW-CV, RDW-SD

• Laboratory — — — • Flags WBC, RBC, PLT (histogram) blasts/abnormal lymphocytes, left shift, atypical



FDA-cleared tests not clinically released — — —Tests not available but submitted for 510(k) clearance — — —Tests in development — — —Tests for research use only — — —Tests unique to analyzer absolute neutrophil count immature granulocyte on every sample, optional

reticulocyte and body fluid licenses availableimmature granulocyte on every sample; models available through authorized distributors for POL and clinic market

Differential method(s) used direct current fluorescent flow cytometry with side fluorescent light, forward-scattered and side-scattered light


Analytical measurement range: • WBC count/RBC count 1.0–99.9/0.3–7.0 0.00–440.00/0.00–8.60 0.00–440.00/0.00–8.60 • Hemoglobin/Platelet 0.1–25.0/10–999 0.0–26.0/0–5,000 0.0–26.0/0–5,000 • MCV (fL) or Hct (%) 10–60 (Hct) 0.0–75.0% (Hct) 0.0–75.0% (Hct) • Reticulocytes — — —

Precision: • WBC count/RBC count <3.5%/<2.0% <3.0%/<1.5% <3.0%/<1.5% • Hemoglobin/Platelet <1.5%/<6.0% <1.0%/<4.0% <1.0%/<4.0% • MCV or Hct <2.0% (Hct) <1.5% (Hct) <1.5% (Hct)


neut% r=0.98, lymph% r=0.99, MXD% r=0.75, neut# r=1.00, lymph# r=1.00, MXD# r=0.90

— —

Interfering substances: • WBC cold agglutinins, PLT clumps, cryoprotein, cryoglobulin, fibrin, giant PLTs (>1 M/µL)



• RBC cold agglutinins, severe microcytosis, fragmented RBCs, leukocytosis (>100,000/µL), giant PLTs (>1 M/µL)



• MCV or Hct cold agglutinins, severe microcytosis, fragmented RBCs, leukocytosis (>100,000/µL), severe diabetes, uremia, spherocytosis



• Platelet PLT clumps, pseudothrombocytopenia, giant PLTs, severe microcytosis, fragmented RBCs, fragmented leukocytes, cryoprotein, cryoglobulin



• Hemoglobin severe lipemia, abnormal protein, leukocytosis (>100,000/µL)




Maximum CBCs per hour/Maximum CBCs and differentials per hour 60/60 60/60 60/60Minimum specimen volume open/Closed/Sample dead volume closed 50 µL/—/— 25 µL/25 µL/1.0 mL 25 µL/25 µL/1.0 mLMicrosample capability yes yes yesPrepares microscope slides automatically or flags problems for slide prep no no noNumber of automatic slidemakers available/List price — — —

Archives patient data/Previous patient results incl. with recent results yes/no yes/yes yes/yesMaximum archived data accessible when system online 40,000 100,000 10,000No. specimens for which numeric results saved in memory at once 40,000 100,000 10,000No. specimens for which histo/cytogram results saved in memory at once 40,000 100,000 10,000Performs delta checks no yes yesTags and holds results for follow-up, confirmatory testing, or rerun yes yes yesParameters for flags for holding samples defined by user or vendor yes yes yesScattergram display: cell-specific color no yes yesHistogram display: color with thresholds yes yes yesUser interface can display choice of specimen or result information yes yes yes

LIS interface formats supported RS-232C XN series ASTM1381-95/ASTM1894-97 or XN series ASTM1381-02/ASTM1894-97


Information transferred on LIS interface numeric and flag results; patient orders, LIS to instrument—broadcast; host query for patient demographics and orders




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

Interface available or planned to automated specimen-handling system — none noneBarcode symbologies read on specimen tube Codabar, codes 39 and 128, ITF, NW-7, UPC-A, UPC-E,

JAN-8, JAN-13Codabar, codes 39 and 128, ITF, NW7, ISBT 128, JAN/EAN/UPC



No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2 1/4 1/4Time required for daily, weekly, monthly maintenance daily: <2 minutes; weekly: <2 minutes; monthly: <2

minutesdaily: 2 minutes; weekly: 15 minutes daily: 2 minutes; weekly: 15 minutes

Onboard diagnostics for troubleshooting/Limited to software problems yes/no yes/no yes/noManufacturer can perform diagnostics via modem no yes yes



automatic floating discriminators, optional upgrade to XP-300 Plus or XP-300 Linc available (data manager and small LIS); ability to directly link to EMR

6-part WBC differential including immature granulocyte in a low volume system; standardization of reagents and controls with existing Sysmex XN-Series analyzers; XN-L Series includes BeyondCare Quality Monitor, an innovative QC and calibration management program, standard on all models

6-part WBC differential including immature granulocyte in a low volume system; standardization of reagents and controls with existing Sysmex XN-Series analyzers; XN-L Series includes BeyondCare Quality Monitor, an innovative QC and calibration management program, standard on all models



Part 13 of 13


Sysmex AmericaKevin Croghan [email protected], IL800-379-7639 www.sysmex.com/us

Name of instrument XW-100First year installed in U.S./Outside U.S./No. of units sold in 2017 2018/—/100No. units installed in U.S./Outside U.S./List price 100/—/—


WBC, RBC, Hb, Hct, MCV, Plt, %&# neut, lymph, HGB, LYM %, LYM #, other WBC #, other WBC %

• Laboratory — • Flags WBC, WBC Diff, PLT, RBC, alert low, alert high, low, high

FDA-cleared tests not clinically released —Tests not available but submitted for 510(k) clearance —Tests in development —Tests for research use only —Tests unique to analyzer direct current detection method

Differential method(s) used adaptive cluster analysis

Analytical measurement range: • WBC count/RBC count 1–63.2/0.3–7.0 • Hemoglobin/Platelet 0.1–25/10–999 • MCV (fL) or Hct (%) 10–60% (Hct) • Reticulocytes —

Precision: • WBC count/RBC count <3.5%/<2.0% • Hemoglobin/Platelet <1.5%/<6.0% • MCV or Hct <2.0% (Hct)


—

Interfering substances: • WBC —

• RBC —

• MCV or Hct —

• Platelet —

• Hemoglobin —

Interfering substances: differential —

Maximum CBCs per hour/Maximum CBCs and differentials per hour —Minimum specimen volume open/Closed/Sample dead volume closed —/15 µL/1.0 mLMicrosample capability noPrepares microscope slides automatically or flags problems for slide prep noNumber of automatic slidemakers available/List price —

Archives patient data/Previous patient results incl. with recent results no/noMaximum archived data accessible when system online —No. specimens for which numeric results saved in memory at once 100No. specimens for which histo/cytogram results saved in memory at once —Performs delta checks noTags and holds results for follow-up, confirmatory testing, or rerun noParameters for flags for holding samples defined by user or vendor noScattergram display: cell-specific color noHistogram display: color with thresholds yesUser interface can display choice of specimen or result information no

LIS interface formats supported none

Information transferred on LIS interface —


no/no/no

Interface available or planned to automated specimen-handling system none

Barcode symbologies read on specimen tube proprietary system (barcodes only)

Accommodates barcode placement per CLSI standard AUTO02-A2 no

No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2 (1 diluent, 1 lyse)

Time required for daily, weekly, monthly maintenance daily: 15 minutes

Onboard diagnostics for troubleshooting/Limited to software problems no/noManufacturer can perform diagnostics via modem no



CLIA-waived CBC, exclusive distribution through McKesson Medical Surgical Division; contains several safety measures to protect the integrity of patient results; simple operation


CAP TODAY product guides help you weigh your options when

it's time for a new instrument or software system

VISIT captodayonline.com /productguides

to view, print, and compare product information for the

following guides:

Coming in December:

urinalysis instrumentation

INSTRUMENTS • AP automation: tissue processors, embedders, microtomes, stainers • Automated molecular platforms • Bedside glucose testing systems • Chemistry and immunoassay analyzers for mid- and high-volume laboratories • Chemistry and immunoassay analyzers for point-of-care and low-volume laboratories • Coagulation analyzers • Coagulation analyzers—point of care, self-monitoring • Hematology analyzers • In vitro blood gas analyzers • Laboratory automation systems and workcells • Next-generation sequencing instruments • Urinalysis instrumentation

SOFTWARE SYSTEMS • Anatomic pathology computer systems • Billing/accounts receivable/ RCM systems • Blood bank information systems • Laboratory information systems • Laboratory-provider links software • Positive patient identification products

APRIL 2018 page 42

42 CAP TODAY | APRIL 2018

POC glucose: views on volume, critical care, ACOsTest volume, limitations on devices used in critical care, consolidation, and population health is what CAP TODAY asked about when it spoke in March with the makers of three bedside glucose testing systems. Their systems and those of two other companies are profiled on pages 44-49.

“The customers are more aware than ever of the limita-tions that are in the package inserts from the glucose manufacturers,” says Corrine Fantz, PhD, director of medical and scientific affairs for point-of-care testing, Roche Diagnostics. But she and Kevin Peacock, clinical marketing manager, HemoCue America, say there is still confusion. Here is more of what they and others told senior editor Amy Carpenter Aquino.

How has the decline in reimbursement coupled with a retreat from tight glycemic control affected test volume for patients at the bedside?

Courtney Sweeney, group marketing manager for point-of-care testing, Roche Diagnostics: Yes, the hospital blood glucose market growth has slowed down, likely due to the overall financial pressures in the industry. Hospitals are looking for the most ef-fective ways to manage costs but also optimize pa-tient outcomes. We do see that point-of-care blood glucose testing remains a critical part of patient care in health systems.

The other general trend is toward outpatient versus inpatient care, and this is attributable to many variables that could drive this, including declining reimbursement, hospital incentives to do interven-tions that impact outcomes, as well as modifying tight glycemic control protocols.

Jeffrey A. DuBois, PhD, MBA, MS, vice presi-dent, medical and scientific affairs, Nova Biomedical: I don’t think people are abandoning glycemic man-agement protocols. They have modified them slight-ly, so they’re not as stringent. Some institutions have made adjustments to the cutoff levels. That is not a retreat from glycemic management; that’s just refin-ing the treatment protocol. Where hypoglycemia may have been defined at 75 mg/dL and below, some institutions now have moved the hypoglyce-mia threshold to 100 mg/dL and below. And there are some people who still want to be aggressive and have the glycemic range between 70 to 110. Many of the institutions have moved the range so that it’s above 100, and it’s referred to as safe and effective glycemic management.

If you’re focusing on total glycemic control for cardiothoracic surgical patients, it depends on the institution. With the increasing number of diabetic patients admitted to the hospital, the demand for monitoring patients at the bedside has not come down. It’s increasing.

I’m not aware of any decline in reimbursement having an effect on bedside glucose testing. We are seeing an increase in bedside glucose testing.

How are your customers adapting to the limitations on glucose devices for critical care applications?

Kevin Peacock, clinical marketing manager, Hemo Cue America: I think we could all hear the collective sigh of relief from the industry, since the 2016 FDA guidance related to strip meter accuracy was not nearly as restrictive as some predicted. Frankly, many customers are still very confused and are uncertain as to what devices are appropriate to use with which patients. HemoCue, having accuracy levels more associated with central lab results, will

continue to be well positioned should the bar be raised even further.

Corrine Fantz, PhD, director of medical and scien-tific affairs for POC testing, Roche: Generally, the customers are more aware than ever of the limitations in the package inserts from the glucose manufacturers. What we’ve seen is that they’re dedicated to determin-ing the best testing approach for their specific popula-tion by first defining the right patient and the right sample in order to achieve high-quality glucose re-sults. We recently sponsored a webinar for customers that allowed the different integrated hospital networks to share their approaches, best practices, and lessons learned while undergoing changes in the systems that had them, or trying to adapt what they were doing to the new limitations with these meters in critical care settings. They said they have to have the right people at the table and understand what the issues are in their particular setting and what’s relevant to physicians, the nursing group, and the laboratory. There needs to be solid communication at all phases with the project. The laboratory directors are the bridge between the point-of-care and hospital medical staff responsible for the testing. Being more collaborative works, rather than the laboratory directing or being an authoritarian type to the clinical staff. You need manufacturers, the clinical staff, and the laboratory all working in a col-laborative environment.

All glucose meters have limitations and no meter currently is approved for use with capillary samples in that critically ill population. There is some confu-sion around that still.

Dr. DuBois (Nova): Our customers are adapting with a focus on patient safety, while conforming to StatStrip labeling requirements. When using the system to measure glucose on critically ill patients, StatStrip and StatStrip Xpress2 are cleared for use with arterial, venous, neonatal heel stick, and neona-tal arterial specimens. The standard of care in most glycemic management protocols we’ve seen, for patient safety reasons, focuses on having either an arterial or a venous whole blood glucose measure-ment. StatStrip demonstrated no known clinically significant interferences that could cause erroneous glucose results contributing to patient adverse events.

Not all bedside glucose monitoring systems are created equal. Other devices in the marketplace have limitations and issues that have been addressed in the peer-reviewed literature and in device package inserts.

How has system consolidation—including established system clinics, ERs, and acquired physician practices—affected POC glucose testing for ambulatory patient testing?

Peacock (HemoCue): We see system consolidation as an advantage for the health systems and the pa-tients they serve. Laboratory professionals have a greater understanding of point-of-care testing, includ-ing regulatory risks, compliance requirements, and testing limitations. As ambulatory sites integrate with hospital systems, lab supervision plays more of a role, even in waived clinics. Laboratorians get the science behind precision and accuracy. They get why our capillary sample is so different from strip meters.

Dr. DuBois (Nova): What is of interest is to have consistency in glucose measurement from home to clinic to hospital and back to home. One of the issues care providers are discussing is that they want uni-

formity in their glucose measurements so there’s consistency in their care path and mode of treating the patients. When we discuss this with European colleagues, what’s important is the alignment of the glucose meter method with a definitive method. If you read carefully the FDA Oct. 11, 2016 guidance for bedside glucose monitoring systems, they must show alignment to a definitive method. Not all of the glucose meters on the market have demonstrated, through FDA submission, alignment to definitive methods. They were approved prior to the guidance. They’re still in the market. Nova StatStrip was not only cleared under FDA for use in the hospitals, in-cluding critically ill patient care settings, but also for use in the home. Now you have a product that can go home to clinic to hospital to clinic to home, and there’s uniformity in glucose measurement.

Sweeney (Roche): Generally, we do see growth in the ambulatory environment. Consolidation may be driving a connected and standardized approach across the health system, which allows for better data management as well as point-of-care oversight.

How does glucose testing and the management of patients with diabetes fit into the concern laboratories have now for population health and accountable care organizations?

Peacock (HemoCue): As medicine becomes less centralized and more personal, there’s not a one-size-fits-all blueprint for patient care. For instance, a considerable part of our population cannot be diag-nosed or effectively monitored with HbA1c alone. Plasma blood glucose continues to be reliable in ef-fectively diagnosing and managing our growing diabetic population.

Dr. Fantz (Roche): What we see is that account-able care organizations are being incentivized to develop health care delivery models that impact the patient population as a whole. This includes preven-tive, chronic or outpatient care, and acute care, or the hospitalized inpatient groups. They have interven-tions that are being implemented to improve glyce-mic control and other outcomes. Glucose testing and managing diabetic patients are essential parts of these interventions. For example, they are expanding point-of-care data management solutions to the outpatient environment. That helps the providers capture and report on outcomes they could not previously capture and report, and those data are helpful for achieving their goals and targets.

Dr. DuBois (Nova): It is probably best addressed by looking at the numbers. When ISO 15197:2003 was published and accepted as the guidance for the FDA prior to Oct. 11, 2016, that guidance permitted five percent of results—below 75 mg, an absolute difference of 15 mg—and above 75 mg, plus or mi-nus 20 percent. If that only has to occur 95 percent of the time, then that poses a significant public health risk. When you look at the number of glucose tests performed on these devices globally, we’re in the neighborhood of 5.6 billion tests. If you multiply that by five percent that are allowed to be acceptable outliers, that means there is the risk of 310 million erroneous glucose results published off these devices that could affect patient care. If there is a device that meets both criteria and they’re held to [accuracy] 98 or 99 percent of the time, then that risk has gone down significantly, especially if it agrees with a definitive method.

0418_42_BedsidePG-Intro_2.indd 42 4/3/18 11:03 AM

22 CAP TODAY | JANUARY 2018

Lab needs driving coagulation analyzer marketValerie Neff Newitt

Customer wish lists help to defi ne every generation of coagulation ana-lyzers, test menus, and related tech-nologies. That’s evident in the recent and upcoming launches and the on-going work of the companies whose analyzers are profi led in this issue in the 2018 coagulation analyzer prod-uct guide.

At Helena Laboratories, “We hear demands for easier connectivity, smaller sample sizes, greater avail-ability of more specialty tests, like low-molecular-weight heparin and direct thrombin inhibitors,” says The-resa Peveto, BSCLS, MT, hemostasis product manager. “And everyone wants a good activated partial throm-boplastin time point-of-care test that is as reliable as an in-laboratory test.” Toward that end, Peveto says Helena Laboratories is well into the develop-ment of a new analyzer with an espe-cially broad platform that will include “new assays not normally seen.”

For instrumentation, the smaller the better. “We will see the industry move toward smaller devices, some-thing like a glucometer—quick, smaller sample sizes, smaller strips, less dependent on technique and technology,” Peveto predicts.

Maria Peluso-Lapsley, MBA, se-nior product marketing manager in

North America for Siemens Health-ineers’ chronic disease portfolio, notes that many customers are ex-panding and gaining more oversight of their hospital-affi liated offi ces and clinics. “They need simple solutions that don’t require a lot of training. They want small analyzers that can transmit data, directly or indirectly via middleware, into their hospital information system and ultimately

into their electronic medical record systems. Additionally, they want technology that does not disrupt fl ow, be it patient fl ow or workfl ow in an offi ce or clinic.”

For the health care networks that want to standardize equipment across the network, “our customers want an end-to-end enterprisewide solution,” Peluso-Lapsley says.

At Instrumentation Laboratory, “We have asked customers, ‘What do you need and what would make your life better?’” says Venita Shirley, MBA, MT(ASCP), director of hemo-stasis marketing in North America. One answer, she says, is time-saving convenience. “In response we have reengineered many reagents to be liquid, ready to use with robust stabil-

ity, eliminating reconstitution time, acclimation time, and repetitive man-ual pipetting.” HemosIL ReadiPlastin for prothrombin time testing on ACL Top and ACL Top Family 50 Series systems, for example, has onboard stability of 10 days, she says.

William Trolio, MBA, MT, vice president and chief scientifi c offi cer, of Bio/Data, says shortening process-ing time is paramount to his custom-

ers. “Specimen processing time is one of the more frustrating parts of platelet testing,” he says. “Platelets are only good for about

four hours. . . . And you may beat up the platelets so much during the preparation that you won’t get the right results due to platelet activation or compromised sample conditions—icterus, hemolysis, or lipemia.”

Bio/Data is working to modify the centrifugation process “to minimize

the amount of g-forces applied and shorten the time so that labs get decent samples,” Trolio says. “Right now people tend to do very slow spins to begin with—20 minutes or longer—

and that is only to prepare half the sample. Then they have to spin it for

another 20 minutes to get the blank. But we are now down to a time frame of under 10 minutes to have the two different samples that are needed. Since platelets are what we do, cen-trifugation is getting a lot of attention from us.” He expects the new centri-fuge will come to the market as a second-generation unit in the fi rst part of this year.

“The health care industry is con-solidating, hospitals are forming groups, groups are joining together and reconfi guring, purchasing is in a constant state of fl ux,” says Susan L. Taylor, MS, MT(ASCP), director, STA marketing, Diagnostica Stago, “and it is all changing how the laboratory must respond. Labs, now recognized as business units, are expected to be centers of value.”

“‘Easy-to-use, reliable, high-throughput equipment that promotes effi ciency and fl exibility’ cannot be a sales pitch,” Taylor says. “Whereas we used to demonstrate the skills and the attributes of an instrument, now we must also demonstrate how they actually serve a specifi c customer in their work environment, in real time, and with their lab team. That is very different for us, but customers have a right to expect it.”

Siemens launched in 2016 its fi rst point-of-care PT/INR device.

The Xprecia Stride is a handheld coagulation analyzer that mimics the look of a smartphone and provides results in 60 seconds or under, Pelu-so-Lapsley says. “While the handheld concept is not new to the industry, what is new is that this device uses the same reagents for PT/INR that are used in the large analyzer portfo-lio. This feature ties into customers’ desire to standardize equipment and reagents and better correlate results.”

Another example of coagulation innovation is preanalytical checks, which “have been on chemistry ana-lyzers forever,” Taylor says. “Now coagulation analyzers are starting to respond in kind.” Diagnostica Stago has developed a module that’s in the presubmission stage with the FDA; the company is aiming for a 2019 en-try into the market. The checks, which will run on the company’s STA Max generation instruments, will detect hemolysis, icterus, and lipemia (HIL).

Taking a somewhat different ap-proach, the ACL Top 50 Series sys-tems from Instrumentation Labora-tory identify and measure the allow-able threshold for HIL. “With the ACL Top 50 Series —continued on 24

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Coagulation Analyzers, pages 25–34Coagulation Analyzers, pages 25–34PRODUCT

GUID

E

Trolio

0118_22-24_Coag.indd 22 1/8/18 3:29 PM

JUNE 2018 page 34

34 CAP TODAY | JUNE 2018

Instrument acquisition, skilled labor on the tableBroad menus, effi cient workfl ows, single platforms, rural labs, cybersecurity, and economics are some of what one CEO and three marketing and product managers talked to CAP TODAY about when we spoke to four companies whose analyzers are profi led in the following product guide (pages 40–46). Details about their analyzers and those of eight other companies are provided in our fi rst combined chemistry/immunoassay product guide, tailored in this issue to the low-volume and point-of-care markets. (See “Simpler and condensed,” page 38, for more on the revised product guide and what to expect next month.)

“The fun part of being a manufacturer,” says Nova Biomedical product manager Brad Bullen, “is trying to keep two and three steps ahead of clinical needs while providing quality diagnostic results that impact patient care now.” Here is more of what he and others shared with senior editor Amy Carpenter Aquino.

What are two key trends in instrument acquisition?

Wayne Brinster, CEO, MedTest Dx: Our customers are looking for fl exibility, with the ability to run a broad menu of tests that allow them to create an efficient workflow. They want the instrument to change with the test mix they’re seeing, and they want the flexibility to re-spond to new tests and not have to do testing offl ine. They haven’t re-linquished the requirement for the instrument to be effi cient as far as the use of reagents, low mainte-nance, and a long time between failures. All of those things come into play to help the laboratorian increase the throughput of the highly automated core instruments.

Laboratories are getting drugs-of-abuse screening tests from the emer-gency department or saliva samples from their occupational health group. If these samples are just added into the normal throughput, they tend to slow down the larger, highly automated instruments.

We’re seeing a desire to take differ-ent types of samples and tests while continuing to have a highly effi cient core laboratory. They can put one of our instruments inside their core lab and dedicate it to offl oad these less effi cient tests.

Brad Bullen, product manager, Nova Biomedical: The fi rst trend is standardization of the hospital plat-

form across the system. You’re able to train one set of employees to cover all hospitals. Trying to do more with less and having a single analyzer that meets the needs across the hospital system is ideal for purchasing agents as well as clinicians. If you’re changing from one analyzer to another, there can be subtle differences in the way results are produced and the timing of the results. Hospitals want a singular fi x for their point-of-care diagnostic needs.

The second trend is cybersecu-rity. Somebody at a large university hospital in California said their laboratory receives about 3,000 external attempts to access their network daily. Hospital systems have had their patient health infor-mation accessed and held for ran-som. Hospital systems and patients have to have confi dence that the systems manufacturers provide are not going to be susceptible to mali-cious software. For a long time, diagnostic companies relied on the hospital’s fi rewall to protect patient data. Nowadays we can’t do that; we need to provide multiple tiers of defense.

Brittany Greiner, marketing man-ager, low-volume and specialty sys-

tems, Roche Diagnostics: We’re see-ing increased interest in standard-ization and a growing need to have a large assay menu on an integrated platform. Specifi cally, when it comes to software interface and assays, it’s important to have the same menu, measuring ranges, and reagents for all the platforms.

Can the industry’s success with auto-mation and ease of use successfully match the worrying decline in skilled labor availability, or does there become a point at which this problem must be addressed by others (in the systems, schools, societies)?

Bullen (Nova): As the mean age of laboratorians is increasing every year, and with fewer enrollees get-ting into this career path, we’re seeing staff having to do more with less. We are not necessarily looking at what’s going to happen 12 months from now but in fi ve years. Nova is developing analyzers that don’t require as much hands-on time to provide quality results, with plug-and-play technology and no maintenance. Basically, take it out of the box, put it on the shelf, load it up with limited con-sumables, have a 15-minute train-ing session, and you should be good to go. That’s the approach we take when developing our ana-lyzer platform.

Everyone is being asked to do more without an increase in staffi ng or reimbursement. Industry has to come to the table with an analyzer that provides outstanding quality results with limited or no hands-on time. Providing a fl exible analyzer platform is a necessity because what might be perfect for one group or department may not meet the clini-cal demands of another.

Brinster (MedTest): The industry has made tremendous strides in ease of use. At the same time, there’s this bifurcation of lab testing. You have some testing that’s going to-ward the patient in the format of waived testing; conversely, there are other testing situations where a laboratory is needed, such as in the larger walk-in clinics. If the current trend in reduction of med techs continues, we will have a real short-age and it will become a problem. There is a need for organizations to continue to work with schools and government to try to promote get-ting more people into medical technology. —continued on 36

Chemistry and immunoassay analyzers pages 40–46Chemistry and immunoassay analyzers pages 40–46PRODUCT

GUID

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OH

H

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MAKERS OF CHEMISTRY, IMMUNOASSAY ANALYZERS ANSWER OUR QUESTIONS

0618_34-38_Chem-Immune-Intro.indd 34 6/6/18 4:31 PM

FEBRUARY 2018 page 32

32 CAP TODAY | FEBRUARY 2018

AP-LIS vendors talk reports, interfaces, protocolsCustomer demand, cancer protocols, and consolidation of pathology practices are some of what CAP TODAYasked about when it spoke in January with four anatomic pathology computer system companies. Their AP systems and those of 17 other companies are profi led on pages 34–47. “It’s a really good time for our market right now,” says Joe Nollar of Xifi n, “and systems providers need to be creative in helping their clients get the solutions they need to be scalable, competitive, and profi table.” Here is more of what they told writer Anne Ford.

How are your reports submitted, and how do they appear in your clients’ electronic medical records?

Lisa-Jean Clifford, CEO, Psyche Systems: We have three options: direct interfaces, if we have a client who’s using just one or two client EMRs; an EMR hub, which allows them to do one to many, and that’s a very cost-effective measure if they have multiple physician offi ces with a lot of disparate EMR sys-tems; and then we offer a clearinghouse module as well, which serves them very well if they have sev-eral clients who are on the same EMR system.

Rick Callahan, vice president of sales and market-ing, NovoPath: More and more, we’re seeing requests to have reports pushed out of the AP-LIS directly into the EMR, if the EMR can accept a PDF. In our world, after the report is fi nalized and signed off by the pa-thologist, there is an application that makes it so that, in a designated time frame, the report is sent auto-matically over the Web to the clinician. This is a big difference from the past when clinicians used to have to log in with a secure password and pull the report down. With NovoPath the report is automatically ending up in the clinicians’ computers or on their printers in their offi ces. With some of the EMRs we’ve been working with, the EMR may not be able to ac-cept a PDF embedded in an HL7 message. In this case, NovoPath will embed a link in the HL7 message going into the EMR, allowing the clinician to access the pathology report through the EMR and pull the PDF directly into their patient’s EMR folder.

Leigh Boje, anatomic pathology product manager, Orchard Software: Our ideal preference would be for us to submit to them a PDF or a fi le format where the pathologist has fi nal say over the format of the report. However, we do have discrete and nondis-crete reporting options. We also see more of our clients establishing their own physician portals, maybe as part of the EMR or maybe as a separate Web portal. Those are reference labs, mostly. We also have the ability to install a piece of software that will directly print to a local printer, and our system will send that print instruction over the Internet with all the formatting instructions, so it prints out the way the lab wants it to print.

Are you seeing consolidation of pathology practices? If so, what are the implications for you as an anatomic pathology system vendor?

Boje (Orchard): Yes, we’re seeing quite a bit of consolidation. One of the hallmarks of our software is that it is a single database platform, so we can in-corporate hybrid comprehensive reports. We can take quantitative data, text, and images, and we can create these complex reports that are so much be-coming the norm.

Callahan (NovoPath): Absolutely we’re seeing consolidation. And we’re starting to see a request for

increased functionality from these labs that they have not had in the past. As an example, we’re getting requests for optical character recognition, which will help streamline the accessioning process. NovoPath can actually import information directly from an EMR-generated requisition. We’re also seeing, since these labs are consolidating, requests to schedule pathologists’ workloads throughout the day. If you have four or fi ve labs consolidating, you might have 15 or 20 pathologists. Some of them have areas in which the pathologists are more skillful at interpret-ing results. We now can schedule differ-ent types of tests to be sent to different pathologists who are working that particular day.

Joe Nollar, associate vice president of product de-velopment, Xifi n: We’re seeing a lot of lab consolida-tion. Years ago, we developed a multi-entity architec-ture for our LIS that allows a lab organization to run multiple performing labs on a single platform. So as labs consolidate, they can very quickly confi gure a new lab entity and get those users up and operational on a standard platform. We’ve seen a lot of clients, especially super-regional labs that are merging with other practices, take advantage of this feature.

Clifford (Psyche): We are seeing a lot of consolida-tion. It tends to be more region-based or test-type based. Obviously, we think it’s an artifact of the reim-bursement models and the change in the CMS reim-bursement rates. But for us as a vendor, what we’re seeing is that through the consolidation, we’re being exposed to more laboratories and having the oppor-tunity to have a bigger footprint within a lab if it is consolidating. A lot of times we win in those scenar-ios. So we’re not generally losing a customer; we’re often gaining a customer or gaining more users.

How has customer demand in general been changing?Nollar (Xifi n): The biggest demand right now is

the expansion into molecular testing and next-gen-eration sequencing and the need to integrate the as-sociated devices and analytics software. Last year, we released a new next-gen module providing more robust wet lab processes for next-gen labs. Part of that process is integrating with the latest next-gen devices and analytics platforms that are either standard off-the-shelf solutions—Illumina, Thermo Fisher—or a homegrown solution within the lab, which may have a proprietary genetic assay it’s running.

Callahan (NovoPath): I think the interfacing tool of laboratory equipment is always a need. From our perspective, nothing has changed. Everybody wants us to act as middleware, and we do. In the past, we used to see pushback based on pricing, but nowadays it seems like laboratories are more accepting of the need to interface to software and hardware in an ef-fort to streamline their workfl ow and reduce errors.

What are the latest ancillary or middleware needs of an AP system? What is the demand like for instrument interfaces?

Boje (Orchard): Digital pathology—having some sort of steps where the LIS can support a digital pathology workfl ow. And then FISH and fl ow cy-tometry, middleware, and integrating the results of those analysis tools back into the report. Instrument

interfaces in autostainers. We’ve been doing auto-stainers for a very long time in a wide variety of manufacturers on almost every project. As far as molecular analyzers, we’re seeing more and more brands of those. Gyn and cytology, we’re seeing plenty of those, and now more and more molecular testing for non-gyn sample types and histology sample types.

Callahan (NovoPath): We’re seeing an uptick in interface demand to whole-slide scanners, and we are happy to comply. Across the entire spectrum,

we’re starting to see re-quests for interfacing to equipment in molecular labs, to EMRs, and to in-

struments such as fl ow cytometers and stainers. Nollar (Xifi n): My recollection is that 20 years ago

in the AP world, it was somewhat rare to do interfac-ing to autostainers and a lot of the histology equip-ment, but of course it’s routine now. If it’s an indi-vidual autostainer or a histology automation system, it’s very common to interact with those devices. And then of course in more complex lab testing with FISH, fl ow, molecular, and next-gen devices and analytics solutions, it’s routine to provide an auto-mated interface.

So the demand continues to grow for instrument interfaces. That’s why I think for LIS providers, le-veraging robust connectivity solutions such as Data Innovations or other is important for clients who want to scale quickly. Obviously, as an LIS provider, we do point-to-point interfaces all the time, but if you can come out of the gate with a library of inter-faces that can be implemented relatively quickly via middleware, it’s much more cost-effective for the client and faster for implementation.

What recommendations do you make to clients for use of the CAP cancer protocols and cancer checklists? And how has this area of customer practice been changing?

Nollar (Xifi n): I think every client looking for an LIS asks about this. The cancer checklists are a critical part of formalizing the diagnosis and making sure that all the information is adequately captured and transmitted to registry, so we’re huge proponents of that. We always encourage folks to go with the for-mal CAP-approved process for generating those reports. Of course, we offer the cancer checklist through our confi gurable text macro dropdowns, but whenever we can, we encourage clients to con-sider CAP eFRM because the synoptic reports are integrated and automatically updated.

Boje (Orchard): We’ve seen a steady increase in use of the cancer protocols. Breast cancer has seen the number one adoption rate, but we’re seeing an uptick in other body sites as well, particularly thyroid.

Clifford (Psyche): We have customers who are interested in taking advantage of the synoptic capa-bilities of the LIS, and many of them enjoy the dy-namic report creation capabilities, so we defi nitely recommend that they integrate with the CAP cancer checklists for increased functionality. And then when we demonstrate the functionality to them, they’re defi nitely interested, especially the pathologists.

Anne Ford is a writer in Evanston, Ill.

Anatomic pathology computer systems, pages 34–47Anatomic pathology computer systems, pages 34–47PRODUCT

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JULY 2018 page 59 JULY 2018 page 58

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.

AUTOMATED MOLECULAR PLATFORMS58 CAP TODAY | OCTOBER 2018 AUTOMATED MOLECULAR PLATFORMS

Part 11 of 17 Hologic HologicGlenn Sawyer [email protected] Glenn Sawyer [email protected]


San Diego, CA San Diego, CA858-410-8000 www.pantherfusion.com, www.hologic.com 858-410-8000 www.hologic.com

Name of instrument Panther Fusion System Panther System

Country where designed/Manufactured/Reagents manufactured U.S./Switzerland/U.S. U.S./Switzerland/U.S.Instrument FDA cleared or approved/Platform yes/preanalytical and analytical yes/preanalytical and analyticalFirst year sold in U.S./Sold internationally/Installed 2017/2017/2017 2012/2010/2010Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 69 × 76 × 32/16.8/<60 69 × 48 × 32/10.6/<55Supplied with UPS/BTU yes/3,412 yes/1,878 per hr.Physical contamination control features closed system, liquid level sensing, pressure-dispense verification closed system, liquid level sensing, pressure-dispense verification, onboard deactiva-

tion, deep-well reaction tube, single sample aspiration and dispense, penetrable cap

List price/Price for sample extraction and amplification detection modules — —Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/— straight purchase, reagent rental, lease/variableCo. performs installation, operation, and performance qualifications/Electrical requirements yes/190–240 VAC, 50–60 Hz, 1,800 VA single phase yes/100–240 V ± 10%Labor and parts warranties/Advanced operator training 1 year/yes 1 year/yesDelivery time/Delivery charges/Installer/Time to install on site ~1 week/variable at origin and destination/Hologic/1–2 days ~1 week/variable at origin and destination/Hologic/1–2 daysTraining location/No. of techs that can receive initial training/ Length of training/Retraining at company facility

off site/2/2–3 days/yes on and off site/2/3 days/yes

Test menu CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, HSV 1&2, Zika, GBS, MRSA, Flu A/B/RSV, Paraflu, AdV/hMPV/RV

CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, HSV 1&2, Zika

No. of tests for which analyzer has FDA-cleared applications/CE mark 13/17 9/12Tests available on instrument in U.S./Outside U.S. CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load,

HSV 1&2, Zika, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV/CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, HSV 1&2, Zika, MRSA, GBS, Flu A/B/RSV, Paraflu, AdV/hMPV/RV

CT-GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load HSV 1&2, Zika/CT-GC, CT, GC, HPV, HPV genotyping, trich, HIV-1 viral load, HCV viral load, HBV viral load, M. gen, HSV 1&2, Zika

Tests not available in U.S. but submitted to FDA/Available in other countries only —/CT, GC, MRSA, Bordetella, M. gen —/CT, GC, M. genResearch-use-only assays/Tests in development —/BV, CV/TV, M. gen —/BV, CV/TV, M. genOpen-channel capabilities/Start-up and preparation time yes/<15 min. yes/<15 min.

Model type of sample-handling system/Maximum sample load capacity automated onboard/120, with continuous and random access automated onboard/120Minimum specimen volume/Sample volume flexibility/Other sample volumes available 400 µL/yes (varies by sample type with open channel capability)/yes 400 µL/no/—Minimum dead volume/Pediatric sample volume/Primary tube sampling 250 µL/no/yes 250 µL/—/yesSample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D various/yes (automated onboard scanner to maintain positive sample ID)/— various/yes/noSample barcode languages/Sample types available in open mode Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/— Codabar codes 39 and 128, Interleaved 2 of 5, JAN13, code 93, UPC, NW7/—Clot detection/Open extraction platform/Sample types (open extraction) yes/no/— yes/no/—

Amplification reagents or methods supported transcription-mediated amplification, real-time TMA, real-time PCR, Invader Plus transcription-mediated amplification, real-time TMANo. of different assays onboard at once/Programmed or calibrated at once up to 32/up to 32 4/4Tests per container set/Multiple reagent configurations supported 12, 100, or 250/yes 100 or 250/yesReagent container placed directly on system/Onboard test auto inventory yes/yes yes/yesDetermines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes yes/yes/yesMonitors expiration date/Auto lot recognition or calibration yes/yes yes/yesAuto detection of adequate reagent or specimen/Reagents available yes/liquid and dry yes/liquidReagent reconstitution required/Chemical contamination control no/yes yes/yesOnboard test auto inventory/Capable of inventory monitoring by barcode yes/yes yes/yesSystem is open to homebrew/General-purpose reagents allowed yes/yes yes/yesSame capabilities when third-party reagent used/Lot sequestering available — —Closed-vial stability for amplification reagents/Extraction reagents assay dependent/assay dependent assay dependent/assay dependentStorage temp. requirement for amplification reagents/Extraction reagents refrigeration/refrigeration refrigeration/refrigerationShipment temp. requirement for amplification reagents/Extraction reagents assay dependent/assay dependent room temperature/room temperatureMinimum/Maximum reagent shelf-life guarantee —/up to 2 years —/up to 2 years

Autocalibration or autocalibration alert/Multipoint calibration supported yes/no yes/—Assay calibrations required by end user/Calibrants can be stored onboard yes/yes yes/yesMultiple calibrant lots stored for same assay/Required calibration frequency no/24 hrs. no/24 hrs.Length of assay calibration/Typical calibration frequency can be user-defined (assay dependent)/24 hrs. 24 hrs./24 hrs.Onboard real-time QC/Supports multiple QC lot numbers per assay —/yes —/yesAuto shutdown*/Instrument warm-up time/Onboard software reviews QC yes/<15 min./yes yes/<15 min./yesTotal number of controls per batch for 24 tests/48 tests/72 tests/96 tests — (not a batch analyzer) — (not a batch analyzer)Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 120 samples/<15 seconds per sample 120 samples/<15 seconds per sampleUses disposable pipette tips/Maximum number of pipette tips stored yes/1,152 yes/576 (2.2 tips per sample)Time between start and initial result/Instrument automatic shutdown 2.4 hrs./yes 2.7–3.5 hrs. (assay dependent)/noStartup programmable/Remote system monitoring/Waste required for disposables yes/yes/plastics and cardboard yes/yes/plastics and cardboardWindows technology/Mouse or touchscreen/Modular add-on capability yes/touchscreen/yes yes/touchscreen/yesService contracts available/Mean time between failures/To repair failures on-demand, pm only, standard, standard plus, premium, premium plus/—/— on-demand, pm only, standard, standard plus, premium, premium plus/—/—Turnaround time for problem solving by phone/Email/Field service — —No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/standard and standard plus: within 24 hrs., premium and premium plus:

within 18 hrs./on-demand, pm only, and standard: M–F, 5 am–5 pm, PT; standard plus, premium, premium plus: 24–7

—/standard and standard plus: within 24 hrs., premium and premium plus: within 18 hrs./on-demand, pm only, and standard: M–F, 5 am–5 pm, PT; standard plus, premium, premium plus: 24–7

Guaranteed response time/Modem servicing avail./System diagnose own malfunctions yes/yes/yes yes/yes/yesOrder parts via modem/Onboard error codes/Maintenance training demo module no/yes/no no/yes/noAverage maintenance time for lab personnel/Onboard maintenance records weekly: <5 min.; monthly: <45 min./yes weekly: <5 min.; monthly: <45 min./yesPreventive maintenance per year for sample extraction/Amplification detection 2/2 2/2Downtime for preventive maintenance/Spare parts on site <1 day/yes <1 day/yes

Software and LIS interface:• Patient demographics and insurance data available via rules-based architecture no no• Data retrieval or Internet connectivity yes yes• Online real-time help, QC, stats, and management reports/Evaluates results validity yes/yes yes/yes• Priority processing yes yes• Supports accession No. redundancy/Specimen carrier and level identification yes/no yes/no• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no yes/no• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions yes/—/yes yes/no/yes• Sample storage and retrieval software supports CLSI standards no no• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/LIS1-A and LIS2-A2 (ASTM) yes/LIS1-A and LIS2-A2 (ASTM)• QC results transferred automatically to LIS/Data-management capability yes/yes yes/yes• Interfaces operational in active user sites yes yes• Rules-based control subsystem/Process control via control subsystem yes/yes yes/yes• LIS operates simultaneously with assays running yes yes• Uses LOINC to transmit orders and results/Unidirectional interface capability no/yes no/yes• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/— yes/—• Stores QC lot files/Worklist edit capability/Viewable PCR graphs —/yes/yes —/yes/—• Can print, archive, transmit data yes yesDistinguishing features (supplied by company)

*for calibration and controls


full sample to result automation; random and continuous access; scheduled/automated maintenance for rapid startup; no return visits required for up to 120 samples/day; no batching requirements; multiple assays from a single sample; ready-to-use reagents for PCR assays; 5-color fluorescence detection; 12 independent onboard thermocyclers

full sample to result automation; random and continuous access; scheduled/automated maintenance for rapid startup; no return visits required for up to 120 samples/day; no batching requirements; runs multiple assays from a single sample; true positive sample ID; consolidated testing menu on a single platform; highest throughput per sq. ft.

Part 12 of 17 HTG Molecular Diagnostics Luminex Corp.Dave DeBonville [email protected] Christine Valle [email protected]


Tucson, AZ Austin, TX952-465-9058 www.htgmolecular.com 512-219-8020 www.luminexcorp.com

Name of instrument HTG EdgeSeq Processor ARIES System

Country where designed/Manufactured/Reagents manufactured U.S./U.S./U.S. U.S./U.S./U.S.Instrument FDA cleared or approved/Platform no (CE-IVD approved)/analytical yes/preanalytical and analyticalFirst year sold in U.S./Sold internationally/Installed 2014/2014/2014 2015/2016/2015Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 17 × 36 × 24/6/<65 38 × 61 × 100 cm/2.5/negligibleSupplied with UPS/BTU no/— yes/2,730Physical contamination control features self-contained waste capture —List price/Price for sample extraction and amplification detection modules $125,000/— $95,000/—Purchase options/Minimum test volume requirements straight purchase, lease/8 samples straight purchase, reagent rental/200 µLCo. performs installation, operation, and performance qualifications/Electrical requirements yes/120–240 V yes/120 VLabor and parts warranties/Advanced operator training 1 year/yes —/noDelivery time/Delivery charges/Installer/Time to install on site 1–4 days/$800 destination/HTG/2 days 2–3 days/per agreement/Luminex/6 hrs.Training location/No. of techs that can receive initial training/ Length of training/Retraining at company facility

on site/2–3/2 days/yes on site/11/1–2 days/yes

Test menu HTG EdgeSeq: ALKPlus assay EU (CE-IVD), DLBCL COO assay EU (CE-IVD), Immuno-Oncology assay (RUO), Oncology Biomarker panel (RUO), Precision Immuno-Oncology panel (RUO), DLBCL COO assay (RUO), PATH panel (RUO), miRNA Whole Transcriptome assay (RUO, human), Mouse miRNA Whole Transcriptome assay (RUO; Q4), Mouse miRNA Tumor Response panel (RUO; Q4)

ARIES Bordetella assay, ARIES C. difficile assay, ARIES Flu A/B & RSV assay, ARIES GBS assay, ARIES HSV 1&2 assay, ARIES Group A strep assay, ASR Primers

No. of tests for which analyzer has FDA-cleared applications/CE mark —/2 6/7Tests available on instrument in U.S./Outside U.S. 8/10 ARIES Bordetella assay, ARIES C. difficile assay, ARIES GBS assay, ARIES HSV 1&2 assay,

ARIES Flu A/B & RSV assay, ARIES Group A strep assay/ARIES Bordetella assay, ARIES C. difficile assay, ARIES Flu A/B & RSV assay, ARIES GBS assay, ARIES HSV 1&2 assay, ARIES Norovirus assay, ARIES Group A strep assay

Tests not available in U.S. but submitted to FDA/Available in other countries only HTG EdgeSeq: DLBCL COO assay, ALKPlus assay/HTG EdgeSeq: DLBCL COO assay EU, ALKPlus assay EU

none/none

Research-use-only assays/Tests in development 8/3 Atopobium vaginae, Fusobacterium, Gardnerella vaginalis, group A strep, adenovirus, enterovirus, varicella zoster virus (VZV), Trichomonas vaginalis, Candida albicans, Candida glabrata/>8

Open-channel capabilities/Start-up and preparation time no/<30 min. yes/<2 min. per sampleModel type of sample-handling system/Maximum sample load capacity manual (lysis only prep)/96 cartridge based/400 µLMinimum specimen volume/Sample volume flexibility/Other sample volumes available single 5-micron FFPE section, 15 µL serum or plasma, PAXGene 32 µL, ≥2,000

cells, extracted RNA/yes (assay and tissue dependent)/assay and tissue dependent200 µL/yes (200–400 µL input)/—

Minimum dead volume/Pediatric sample volume/Primary tube sampling —/—/no —Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D uses 96-well microtiter plate/no/yes —/yes/noSample barcode languages/Sample types available in open mode —/assay and tissue dependent —Clot detection/Open extraction platform/Sample types (open extraction) no/no/assay and tissue dependent no/no/dependent on assayAmplification reagents or methods supported — real-time PCRNo. of different assays onboard at once/Programmed or calibrated at once 1/8 up to 12/up to 12Tests per container set/Multiple reagent configurations supported up to 8, 24, or 96/yes 24/—Reagent container placed directly on system/Onboard test auto inventory yes/no yes/noDetermines reagent volume in container/Reagent barcode reading/Reagents barcoded no/yes/yes no/yes/yesMonitors expiration date/Auto lot recognition or calibration yes/yes yes/yesAuto detection of adequate reagent or specimen/Reagents available no/liquid no/liquid and dryReagent reconstitution required/Chemical contamination control no/onboard waste capture no/—Onboard test auto inventory/Capable of inventory monitoring by barcode no/no no/noSystem is open to homebrew/General-purpose reagents allowed no/no yes/yesSame capabilities when third-party reagent used/Lot sequestering available no/yes yes/noClosed-vial stability for amplification reagents/Extraction reagents — 9 months, planned to 18 months/9 months, planned to 18 monthsStorage temp. requirement for amplification reagents/Extraction reagents — room temperature/room temperatureShipment temp. requirement for amplification reagents/Extraction reagents — refrigeration/refrigerationMinimum/Maximum reagent shelf-life guarantee reagent dependent/12 months 9 months, planned to 18 months/9 months, planned to 18 monthsAutocalibration or autocalibration alert/Multipoint calibration supported no/— yes/noAssay calibrations required by end user/Calibrants can be stored onboard — no/noMultiple calibrant lots stored for same assay/Required calibration frequency no/at install no/—Length of assay calibration/Typical calibration frequency — —Onboard real-time QC/Supports multiple QC lot numbers per assay no/yes yes/yesAuto shutdown*/Instrument warm-up time/Onboard software reviews QC no/—/no yes/5 min. for initialization/yesTotal number of controls per batch for 24 tests/48 tests/72 tests/96 tests user determined internal sample processing control (SPC) in each cartridgeWalkaway capacity/Tech hands-on time (both for batch of 96 samples) up to 96 samples/30 min. 2 hrs. per run, batched 12 samples per run/<2 min. per sampleUses disposable pipette tips/Maximum number of pipette tips stored yes/386 yes/tips not stored on instrumentTime between start and initial result/Instrument automatic shutdown ~20 hrs./no 2 hrs./yesStartup programmable/Remote system monitoring/Waste required for disposables no/no/plastic, contained liquid yes/yes/biohazard disposalWindows technology/Mouse or touchscreen/Modular add-on capability yes/mouse/yes yes/touchscreen/noService contracts available/Mean time between failures/To repair failures yearly (parts and labor)/—/2–3 days Bronze, Silver, Gold, Gold+, Platinum, Diamond/26 weeks/4.8 hrs.Turnaround time for problem solving by phone/Email/Field service <1 hr./<1 hr./24–72 hrs. 1 hr./1 hr./—No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/24–72 hrs./M–F, 10 hrs. 23/varies per contract: next business day to second business day/M–F, 8 am–6 pm

Guaranteed response time/Modem servicing avail./System diagnose own malfunctions no/no/yes yes, per service contract/no/noOrder parts via modem/Onboard error codes/Maintenance training demo module no/yes/yes no/yes/—Average maintenance time for lab personnel/Onboard maintenance records daily: 10 min.; weekly: 90 min./yes daily: 5 min.; monthly: 15 min./noPreventive maintenance per year for sample extraction/Amplification detection — 1/1Downtime for preventive maintenance/Spare parts on site 8 hrs./no 4 hrs./no Software and LIS interface:• Patient demographics and insurance data available via rules-based architecture yes no• Data retrieval or Internet connectivity yes yes• Online real-time help, QC, stats, and management reports/Evaluates results validity yes/no yes/yes• Priority processing no no• Supports accession No. redundancy/Specimen carrier and level identification yes/no yes/no• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no yes/—• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions no/no/no no/—/no• Sample storage and retrieval software supports CLSI standards — no• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS no/— yes/HL7, CSV• QC results transferred automatically to LIS/Data-management capability no/yes yes/yes• Interfaces operational in active user sites — yes• Rules-based control subsystem/Process control via control subsystem — yes/no• LIS operates simultaneously with assays running no yes• Uses LOINC to transmit orders and results/Unidirectional interface capability no/— no/—• Results immediately transmitted to LIS/Interface available to auto specimen-handling system no/no yes/no• Stores QC lot files/Worklist edit capability/Viewable PCR graphs — yes/yes/yes• Can print, archive, transmit data yes yesDistinguishing features (supplied by company)*for calibration and controlsNote: a dash in lieu of an answer means company did not answer question or question is not applicable

low specimen input requirements without the need for DNA or RNA extraction; highly multiplexed assay (>2,000 targets) results with walkaway automation; simplified data reporting for targeted next-generation sequencing

capability to design and run LDTs alongside IVD assays with customizable assay protocol files; SYNCT software allows for visibility/communication to any networked ARIES instruments; ARIES onboard software allows for bidirectional communication to LIS

1018_45-64_Molec-PG.indd 58 10/5/18 4:40 PM

JULY 2018 page 44

44 CAP TODAY | JULY 2018

Menu, security, consistency: vendors point to prioritiesChemistry and immunoassay analyzers combined—that’s what is new about the product guide that begins on page 49. In years past, the chemistry and immunoas-say analyzer product guides were pub-lished separately. This year we integrated them and are publishing them in two is-sues: last month for the low-volume and point-of-care markets and this month for the mid- to high-volume laboratory market. Each company decided on its own in which issue to list its analyzer(s) and used our revised questionnaire to provide us with the de-tail you will fi nd in pages 49–70.

CAP TODAY spoke with fi ve of the

companies that have analyzers for the mid- to high-volume market. We asked them what we asked a different set of companies in the June issue—about in-strument acquisition trends, the concerns

they’re hearing from custom-ers, and more. Here is what they told CAP TODAY senior editor Amy Carpenter Aquino. (Abbott Diagnostics’ analyzer is not listed in the product guide because Abbott was in

the process of launching a new product line in the U.S. and could not provide details about its analyzer [http://bit.ly/Abbott_Alinity] until it was offi cially an-nounced, which was after CAP TODAY’s deadline.)

What are two key trends in instrument acquisition?

Joe Amodeo, marketing manager, Atellica Solutions, Siemens Health-ineers: We are seeing a longer life cycle for analyzers. Customers used to think about replacing equipment on a consistent fi ve-year basis. That is lengthening to an average life cycle of seven years for a given analyzer, though it remains customer and in-strument specifi c. The reliability of analyzers on the market today is al-ways improving. As long as custom-ers have that reliability and they’re meeting the metrics they’ve assigned themselves, they’d rather reserve those dollars.

Changes to lease classification rules issued by the Financial Ac-counting Standards Board in 2013 forced labs to account for instrumen-tation on the balance sheet. That has created an environment in which customers are required to understand any fi nancial implications of acquir-ing capital if funds are not readily available. That might mean fi nding new and creative ways to bridge dif-ferent budget cycles if their specifi c project isn’t funded in the preferred replacement time period.

Nadav Kaufman, senior director, product management, clinical lab menu, Ortho Clinical Diagnostics:Customers are looking for instru-ments that truly integrate chemistry and immunoassay diagnostic testing, with or without a track. They’re seek-ing instruments that allow them to grow in menu and throughput as their laboratory’s needs evolve, with-out requiring major capital invest-ments like increased footprint or plumbing systems.

We’re also seeing customers enter into longer-term partnerships with vendors based on alignment with that selected vendor’s vision for the future and their capacity for continu-ous improvement in areas that de-liver greater medical value.

Chris Cook, PharmD, senior direc-tor, antimicrobial stewardship, Bio-Mérieux: One trend is consolidation of laboratory instruments, which means having a broader menu on the same instrument. Connectivity and analytical solutions tied to the instru-ment also are becoming more important.

Tamara McCarthy, senior product manager, systems, Binding Site: Ap-provals take longer and involve more stakeholders, which may be due to hospitals consolidating or becoming part of a larger network. Decisions

made at a local level previously may now need to wait for approval from larger organizations.

Information technology depart-ments are more involved now in the labs and health care systems. This is to ensure the safety of protected health information and compliance with HIPAA.

Vahe Ayvazian, U.S. marketing director, Abbott Diagnostics: Labs are looking beyond the instrument and assays at a total solution and how it can optimize their performance as well as add value to the entire health care organization.

We also see a concerted effort to purchase harmonized systems that are highly reliable and easy to use and address fundamental operational needs: broad menus for testing con-solidation, scalability for future growth and operational capacity management, effi cient footprint for return on investment, error reduction, commonality across system disci-plines for ease of use, operational training, and staff optimization.

Which do you see most notably: a desire for one platform family to serve all sites, firm long-term pricing, compatibility with electronic medical record system, adaptability through middleware, ease of ordinary reporting, or menu expansion and development?

Kaufman (Ortho): Having one platform is critical to our customers as health systems become better or-ganized. They’re looking for a one-platform family and consistency across the reagents, values, training, service, and supplies.

We consistently hear that custom-ers are interested in more novel medi-cal content and expanding menus. They are particularly interested in tests that can help the lab play a big-ger role in driving a change in how diseases are managed. For example, the NephroCheck test for risk of acute kidney injury allows laboratories to be involved in helping physicians get in front of a complication they were previously unable to predict and manage.

Dr. Cook (BioMérieux): Our cus-tomers are most interested in menu expansion and development. We aim to expand our offering through unique, high-value medical solutions like the Vidas procalcitonin, Nephro-Check, and Banyan mTBI biomarker tests.

Amodeo (Siemens Healthineers):Labs are increasingly transitioning from buying

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—continued on 46

Chemistry and immunoassay

analyzers,pages 49–70

Chemistry and immunoassay

analyzers,

PRODUCT

GUID

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NOVEMBER 2018 page 67 - CAP TODAY€¦ · size; reliable: system averages one service call per year; easy to use: system has touchscreen software with intuitive icons and minimal