POCT - advanceweb.com · 78 | advance/Laboratory • April 2006 POCT Company Info Product Name Type of Analyzer Size and Weight/Cost Type of Design Primary Area

78 | advance/Laboratory • April 2006 www.advanceweb.com

POCTCompany Info Product Name Type of

AnalyzerSize and Weight/Cost

Type of Design

Primary Area of Use

Test Menu Sample Type Product Reference Methods

Error Tolerances to Measure Performance

QC Features Security Features

Sample Size Required

Analytical Principle for Each Analyte

Turnaround Time for Results

Downloading Capabilities

Internal or External Connectivity

Connectivity Options

Availability of Wireless Communi-cation

Compliance with CLSI-POCT1A

Utilization of CLSI Technical Performance Standards

Utilization of CLSI Automation Standards

Remote Lock-out/Operation

Distinguishing Features

Abbott Point of Care

104 Windsor Center DriveEast Windsor, NJ 08520

Contact: i-STAT 1Michael A. Saperstein (609) 443-9300

E-mail: [email protected];[email protected]

Web Site: www.abbottpointofcare.com

i-STAT 1 Portable Clini-cal Analyzer

W x D x L = 2.5 in x 2.0 in x 8.2 in; Weight – 18 oz

Handheld Emergency de-partments, respi-ratory therapy, transports, mil-itary (field); any place bedside blood analysis is required

Variety of blood gas-es, electrolytes, chemistries, co-agulation, cardi-ac markers

Whole blood Standard lab methodologies (impedance, elec-trogenic)

Yes Internal, auto-matic electron-ic QC

Input for user and patient ID numbers; user programmable

Approx. 2 drops (var-ies by test cartridge)

Blood Gas/Chem/Electrolyte: am-perometric; Coagu-lation: electrogenic; Immunoassay: ELI-SA/amperometric

Approx. 2 minutes (var-ies by car-tridge)

Yes Yes Yes, most com-mercial data management packages

Infrared Yes Yes Yes Yes Portable 1.0 lb analyz-er can perform electro-lytes, chemistry, blood gas, coagulation and cardiac markers on single platform

Contact: Precision PCxKen Stoner(609) 469-0322fax: (609) 443-9310

Web Site:www.abbottpointofcare.com

Precision PCx Glucose Meter 7.7” x 2.9” x 2”, 10 oz./ $995

Handheld; glucose only; test strip

Hospital-wide Glucose Whole blood/drop, can apply blood directly to test strip

YSI Accuracy: cap-illary blood y=0.91x + 0.91, r=0.98/YSI. Precision: Blood samples: CV 2.9% to 5.1%

User-defined QC lockout; stores 4,000 patient results and 1,000 QC with full date and time; oper-ator ID and pa-tient ID; data review

QC lockout for user ID fail-ure, QC failure, download time if selected

3.5 micro-liters with PCx/2.5 mi-croliters with PCx Plus

Amperomet-ric: Glucose oxi-dase with Precision PCx strips. Glu-cose dehydroge-nase with PCx Plus test strips

20 seconds Hands-free data download-ing via docking station

Yes TCP/TP, RS-232, bi-directional

Future de-velopment

Yes Yes Yes User defined remote con-trol of instru-ment and reagents; QC lockout for user ID fail-ure; QC fail-ure; download time if se-lected

Patented fill-trigger electrode designed to start test only when sufficient sample is detected; ability to re-apply blood within 30 seconds; positive re-agent ID, positive cal-ibration ID-no need to visually verify code key against test strip vial; state-of-the-art inter-facing to HIS and LIS systems via QC Man-ager; sybase interfac-ing engine

Bayer HealthCare Diagnostics Division

Contact: Susan Oelerking(914) 631-8000

E-mail:[email protected]

Web Site:www.bayerdiag.com

Clinitek Status Analyzer

Urinalysis analyzer for POC/POL

D x W x H = 10.7 in x 6.7 in x 6.2 in; 3.65 lbs.

LED optics, 6 wavelengths

Urinalysis screening, hCG screening in POC/POL

Range of Bay-er’s most pop-ular urinalysis reagent strips including Mul-tistix® 10SG, Multistix® 8SG, Multistix PRO®, Clinitek® Mi-croalbumin and Clinitest® hCG Test. Addition-al tests and im-munoassays to come.

Urine Reference meth-od depends on analyte being tested

Error tolerances depend on ana-lyte being mea-sured

Numerous user-interface prompts

Password pro-tected instru-ment settings

1 minute RS232 inter-face for data download to POC interface

Yes PC, Point-of-Care LIS

No Simple to use; user in-terface with touch screen operation; pa-tient information and operator identification input; broad menu; 200 test memory is downloadable for im-proved data manage-ment; battery and/or main operation

DCA 2000®+ Analyzer with DCA 2000 He-moglobin A1c reagent kit

Immuno-chemistry Ana-lyzer/Diabetes Analyzer

Immuno-chemistry an-alyzer

Diabetes man-agement

Quantitative measurement of Hemoglo-bin A1c

Blood HPLC Standard con-trol solutions available

Numerous in-ternal perfor-mance checks

1 uL Inhibition of la-tex agglutination assay

6 minutes RS 232 Inter-face

LIS, PC RS 232 No No No No NGSP Certified, IFCC Certified

DCA 2000®+ Analyzer with Microalbumin/Creatinine Re-agent Kit




Quantitative de-termination of Microalbumin:Creatinine ratio

Urine Immunoassay/JAFFE reaction

Standard con-trols

System perfor-mance checks

40 uL Antibody binds with albumin Benedict/Dehre Chemistry for cre-atinine


LIS, PC RS 232 No No No No No NGSP Certified, IFCC Certified

Rapidpoint 400/405 blood gas analyzer

Blood gas W x D x H = 11.5 in x 16 in x 21.5 in; 31 lbs.

Integrated, multi-use cartridge sys-tem

ICU, ER, OR, RT Measured (range) pH; pCO2, mm Hg; pO2, mm Hg; BP, mm Hg; Hct, %; K+, mmol/L; NA+, mmol/L; Ca++, mmol/L; CL-, mmol/L; Others (Cl-, Glucose, tHb, CO-ox Derived: a/A; A-aDO2; BE; BEecf; Hb; HCO3; ctOs; SB; SO2; ctCO2 Oth-ers: A-a/a DO2; RI; BO2

Heparinized whole blood

Analyte reference method

Ampouled QC or automatic QC module; QC lockout; remote QC triggering

Three levels for 500 users

100–200 uL Direct potentiom-etry ( pH, pCO2, NA+, CA++, CL-, K+) amperome-try (pO2, glucose) corrected conduc-timetry (Hct) mut-li-wavelengths spectrophotome-try on whole blood (tHB, O2Hb, COHb, MetHb, HHb)

60 seconds Ability to down-load patient data; calibra-tion and QC in-formation

RS 232, TCP-IP

Optional No Yes First blood gas system specifically designed for POC with integrated CO-oximetry for com-prehensive and ac-curate oxygen status; intuitive user interface with onboard train-ing video, high-level of bio safety; six types of measuring cartridges

BUYERS GUIDE

6Th AnnUAl

The 6th annual “ADVANCE Point-of-Care Testing Buyers Guide” represents a collaborative effort between laboratory administrators, POCT manufacturers and ADVANCE editorial staff.

Here, respondents surveyed offer POCT-related products for hospital and non-hospital laboratories.

Designed for ease of use, this chart includes contact names, telephone/fax numbers, e-mail/Web site address-es, product and cost, type of analyzer, size and weight of device, type of design and other POCT product-specific

EDITOR’S nOTE:

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www.advanceweb.com advance/Laboratory • April 2006 | 79

Company Info Product Name Type of Analyzer

Size and Weight/Cost

Type of Design

Primary Area of Use
















Abbott Point of Care

104 Windsor Center DriveEast Windsor, NJ 08520

Contact: i-STAT 1Michael A. Saperstein (609) 443-9300

E-mail: [email protected];[email protected]

Web Site: www.abbottpointofcare.com

i-STAT 1 Portable Clini-cal Analyzer

W x D x L = 2.5 in x 2.0 in x 8.2 in; Weight – 18 oz

Handheld Emergency de-partments, respi-ratory therapy, transports, mil-itary (field); any place bedside blood analysis is required

Variety of blood gas-es, electrolytes, chemistries, co-agulation, cardi-ac markers

Whole blood Standard lab methodologies (impedance, elec-trogenic)

Yes Internal, auto-matic electron-ic QC

Input for user and patient ID numbers; user programmable

Approx. 2 drops (var-ies by test cartridge)

Blood Gas/Chem/Electrolyte: am-perometric; Coagu-lation: electrogenic; Immunoassay: ELI-SA/amperometric

Approx. 2 minutes (var-ies by car-tridge)

Yes Yes Yes, most com-mercial data management packages

Infrared Yes Yes Yes Yes Portable 1.0 lb analyz-er can perform electro-lytes, chemistry, blood gas, coagulation and cardiac markers on single platform

Contact: Precision PCxKen Stoner(609) 469-0322fax: (609) 443-9310

Web Site:www.abbottpointofcare.com

Precision PCx Glucose Meter 7.7” x 2.9” x 2”, 10 oz./ $995

Handheld; glucose only; test strip

Hospital-wide Glucose Whole blood/drop, can apply blood directly to test strip

YSI Accuracy: cap-illary blood y=0.91x + 0.91, r=0.98/YSI. Precision: Blood samples: CV 2.9% to 5.1%

User-defined QC lockout; stores 4,000 patient results and 1,000 QC with full date and time; oper-ator ID and pa-tient ID; data review

QC lockout for user ID fail-ure, QC failure, download time if selected

3.5 micro-liters with PCx/2.5 mi-croliters with PCx Plus

Amperomet-ric: Glucose oxi-dase with Precision PCx strips. Glu-cose dehydroge-nase with PCx Plus test strips

20 seconds Hands-free data download-ing via docking station

Yes TCP/TP, RS-232, bi-directional

Future de-velopment

Yes Yes Yes User defined remote con-trol of instru-ment and reagents; QC lockout for user ID fail-ure; QC fail-ure; download time if se-lected

Patented fill-trigger electrode designed to start test only when sufficient sample is detected; ability to re-apply blood within 30 seconds; positive re-agent ID, positive cal-ibration ID-no need to visually verify code key against test strip vial; state-of-the-art inter-facing to HIS and LIS systems via QC Man-ager; sybase interfac-ing engine

Bayer HealthCare Diagnostics Division

Contact: Susan Oelerking(914) 631-8000


Web Site:www.bayerdiag.com

Clinitek Status Analyzer

Urinalysis analyzer for POC/POL

D x W x H = 10.7 in x 6.7 in x 6.2 in; 3.65 lbs.

LED optics, 6 wavelengths

Urinalysis screening, hCG screening in POC/POL

Range of Bay-er’s most pop-ular urinalysis reagent strips including Mul-tistix® 10SG, Multistix® 8SG, Multistix PRO®, Clinitek® Mi-croalbumin and Clinitest® hCG Test. Addition-al tests and im-munoassays to come.

Urine Reference meth-od depends on analyte being tested

Error tolerances depend on ana-lyte being mea-sured

Numerous user-interface prompts

Password pro-tected instru-ment settings

1 minute RS232 inter-face for data download to POC interface

Yes PC, Point-of-Care LIS

No Simple to use; user in-terface with touch screen operation; pa-tient information and operator identification input; broad menu; 200 test memory is downloadable for im-proved data manage-ment; battery and/or main operation

DCA 2000®+ Analyzer with DCA 2000 He-moglobin A1c reagent kit

Immuno-chemistry Ana-lyzer/Diabetes Analyzer



Quantitative measurement of Hemoglo-bin A1c

Blood HPLC Standard con-trol solutions available

Numerous in-ternal perfor-mance checks

1 uL Inhibition of la-tex agglutination assay


LIS, PC RS 232 No No No No NGSP Certified, IFCC Certified

DCA 2000®+ Analyzer with Microalbumin/Creatinine Re-agent Kit




Quantitative de-termination of Microalbumin:Creatinine ratio

Urine Immunoassay/JAFFE reaction

Standard con-trols

System perfor-mance checks

40 uL Antibody binds with albumin Benedict/Dehre Chemistry for cre-atinine


LIS, PC RS 232 No No No No No NGSP Certified, IFCC Certified

Rapidpoint 400/405 blood gas analyzer

Blood gas W x D x H = 11.5 in x 16 in x 21.5 in; 31 lbs.

Integrated, multi-use cartridge sys-tem

ICU, ER, OR, RT Measured (range) pH; pCO2, mm Hg; pO2, mm Hg; BP, mm Hg; Hct, %; K+, mmol/L; NA+, mmol/L; Ca++, mmol/L; CL-, mmol/L; Others (Cl-, Glucose, tHb, CO-ox Derived: a/A; A-aDO2; BE; BEecf; Hb; HCO3; ctOs; SB; SO2; ctCO2 Oth-ers: A-a/a DO2; RI; BO2

Heparinized whole blood

Analyte reference method

Ampouled QC or automatic QC module; QC lockout; remote QC triggering

Three levels for 500 users

100–200 uL Direct potentiom-etry ( pH, pCO2, NA+, CA++, CL-, K+) amperome-try (pO2, glucose) corrected conduc-timetry (Hct) mut-li-wavelengths spectrophotome-try on whole blood (tHB, O2Hb, COHb, MetHb, HHb)

60 seconds Ability to down-load patient data; calibra-tion and QC in-formation

RS 232, TCP-IP

Optional No Yes First blood gas system specifically designed for POC with integrated CO-oximetry for com-prehensive and ac-curate oxygen status; intuitive user interface with onboard train-ing video, high-level of bio safety; six types of measuring cartridges

6th annual poct buyers guide

information. The Distinguishing Features category identifies a product’s top features.

ADVANCE relies on its readership to improve the quality of special sections. If you find this buyers guide useful or if you have suggestions to increase its effectiveness, please contact us or forward a letter to:

Lynn Nace, Editor, ADVANCE for Administrators of the Laboratory, 2900 Horizon Drive, King of Prussia, PA 19406, or e-mail [email protected].

Listings do not represent endorsement by ADVANCE.

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Bio-Rad Laboratories

Contact:

Customer Service (800) 854-6737

Web Site:www.bio-rad.com

Quality con-trol products, including Me-ter Trax Con-trol, a whole blood control for glucose, he-moglobin and hematocrit test-ing; urine tox-icology and other controls are available

Glucose: Accu-Chek ADVAN-TAGE, Asencia Elite, MediS-ense Precision Xtra, Fast Take, Glucometer ENCORE QA, One Touch II, Profile, Pre-cision Q-I-D, Precision G, Precision Pcx, Sure Step. Hemoglobin: Hemocue, Re-flotron, SPUN-CRIT, Manual Methods. He-matocrit: He-mataStat, IEC (PCV), i-STAT, READACRIT, SPUNCRIT, Statspin III, IV & V, StatSpin MP, CritSpin. Urine Toxicol-ogy: TOX/SEE, Biosite Triage and other POC methods

Dade Behring Inc.

Contact: Leslie Dakarian(847) 236-7286

E-mail: [email protected]

Web Site:www.dadebehring.com

Stratus® CS Acute Care™ Diagnostic Sys-tem

Stat and near patient test-ing for cardiac assays, BhCG and D-dimer

18 in x 27 in x 22 in; 140 lbs

Acute Care™ Kiosk that consists of an instrument, transportable cart, refriger-ator and un-interruptible power sup-ply; may also be used as a benchtop in-strument

ED, stat labs, coronary care units, urgent care centers, main labs

Troponin-I, NT-proBNP myo-globin, mass CKMB, D-di-mer, and BhCG. CardioPhase® hsCRP in devel-opment

Heparinized whole blood and plasma

Internal reference preparations for cardiac assays and D-dimer; 3rd IS for BhCG

Microproces-sor continuously monitors all op-erating systems to ensure per-formance within specifications

System check: Electronic QC to meet daily QC requirements

System check lock-out: Re-quires Sys-tem Check to be performed within lab de-fined period of time

Liquid QC Lock-out: Requires liquid QC to be performed within lab de-fined period of time

Liquid QC Range Lock-out: Prevents patient testing when QC is out of lab defined QC range

Critical Config-urations: Lab password pro-tection

Operator Val-idation: Valid operator ID re-quired

Minimum 3 ml whole blood; 200 uL of plas-ma

Solid phase two-site sandwich fluorometric im-munoassay uti-lizing single use TestPaks to help eliminate contami-nation and reagent waste

Approximate-ly 14 minutes to first result; 4 minutes for each addi-tional

LIS compatible (RS-232) with uni-directional download

Instrument can inter-face direct-ly to the LIS or to POC connectivity middleware (see con-nectivity op-tions)

POC Connectiv-ity Middleware Options: Tel-cor Quick-Linc® and QML®; Med-ical Automation Systems RALS-Plus®

No The SCS is compliant with POCT 1A when interfaced with Tel-cor Quick-Linc® and QML®; Medical Automation Systems RALS-Plus®

N/A Automatic lockout based on QC perfor-mance, oper-ator validation and instru-ment status

The Stratus CS Analyz-er, designed for acute-care diagnostics, is a model of cost-effec-tiveness for both your laboratory and near-patient setting; it’s a random-access ana-lyzer, delivering quanti-tative cardiac markers, BhCG, D-Dimer results from a whole blood sample in as little as 14 minutes; the simple three-step process—load sample and ro-tor, load testpack(s) and press Start— is easy to use by all skill levels

HemoCue Inc.Contact:

(800) 881-1611E-mail:

[email protected] Web Site:

www.hemocue.com

Hb 201+ An-alyzer

Hemoglo-bin testing for point of care

3.35 in x 6.3 in x 1.69 in; .77 lbs

Handheld; portable; single-use testing: mi-crocuvette

Physician office, hospital, blood bank, dialysis center and pub-lic health

Single analyte Whole blood International Ref-erence Method (ICSH)

Automatic self-test

10 µl Absorbance pho-tometry; Azidemet-hemoglobin

<1 minute Lab quality results at the point of care; mea-sure at two wave-lengths to correct for turbidity; minimum of interferences; no lot-to-lot variation; no re-calibration needed

Glucose 201 Analyzer

Glucose test-ing

3.35 in x 6.3 in x 1.69 in; .77 lbs


Physician office and hospital

Single analyte Whole blood Wet chemical glucose dehydro-genase

Automatic self-test

5 µl Absorbance pho-tometry; glucose dehydrogenase

40–240 sec-onds

Lab quality results at the point of care; cleared for screening, diagnosing and mon-itoring of diabetes; off meter dosage; mini-mum of interferences; no lot-to-lot varia-tion; no recalibration needed

Hb 201 DM An-alyzer

Hemoglobin testing with data manage-ment features

3.66 in x 6.7 in x 1.97 in; .77 lbs


Hospital Single analyte Whole blood International Ref-erence Method (ICSH)

QC lockout; op-erator ID; con-trol lot number; reagent lot number; date/time; result; range; pass/fail; comment code

Certified oper-ator ID and pa-tient ID entry, settings and memory erase functions may be password protected


<1 minute Ethernet or USB to PC or laptop for full bi-direction-al communica-tion providing downloading and configura-tion features

Fully net-workable “out of the box”; may be inter-faced to LIS/HIS using third party software

LIS connectivity through third par-ty vendor

No Yes Yes No Yes; can be superviso-ry locked out using the He-moCue 201 DM PC Soft-ware

Lab quality results at the point of care; measure at two wave-lengths to correct for turbidity; full data, op-erator and analyzer management funtion-ality; minimum of interferences; no lot-to-lot variation; no re-calibration needed



Type of Design

Primary Area of Use
















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Bio-Rad Laboratories

Contact:

Customer Service (800) 854-6737

Web Site:www.bio-rad.com

Quality con-trol products, including Me-ter Trax Con-trol, a whole blood control for glucose, he-moglobin and hematocrit test-ing; urine tox-icology and other controls are available

Glucose: Accu-Chek ADVAN-TAGE, Asencia Elite, MediS-ense Precision Xtra, Fast Take, Glucometer ENCORE QA, One Touch II, Profile, Pre-cision Q-I-D, Precision G, Precision Pcx, Sure Step. Hemoglobin: Hemocue, Re-flotron, SPUN-CRIT, Manual Methods. He-matocrit: He-mataStat, IEC (PCV), i-STAT, READACRIT, SPUNCRIT, Statspin III, IV & V, StatSpin MP, CritSpin. Urine Toxicol-ogy: TOX/SEE, Biosite Triage and other POC methods

Dade Behring Inc.

Contact: Leslie Dakarian(847) 236-7286


Web Site:www.dadebehring.com

Stratus® CS Acute Care™ Diagnostic Sys-tem

Stat and near patient test-ing for cardiac assays, BhCG and D-dimer

18 in x 27 in x 22 in; 140 lbs

Acute Care™ Kiosk that consists of an instrument, transportable cart, refriger-ator and un-interruptible power sup-ply; may also be used as a benchtop in-strument

ED, stat labs, coronary care units, urgent care centers, main labs

Troponin-I, NT-proBNP myo-globin, mass CKMB, D-di-mer, and BhCG. CardioPhase® hsCRP in devel-opment

Heparinized whole blood and plasma

Internal reference preparations for cardiac assays and D-dimer; 3rd IS for BhCG

Microproces-sor continuously monitors all op-erating systems to ensure per-formance within specifications

System check: Electronic QC to meet daily QC requirements

System check lock-out: Re-quires Sys-tem Check to be performed within lab de-fined period of time

Liquid QC Lock-out: Requires liquid QC to be performed within lab de-fined period of time

Liquid QC Range Lock-out: Prevents patient testing when QC is out of lab defined QC range

Critical Config-urations: Lab password pro-tection

Operator Val-idation: Valid operator ID re-quired

Minimum 3 ml whole blood; 200 uL of plas-ma

Solid phase two-site sandwich fluorometric im-munoassay uti-lizing single use TestPaks to help eliminate contami-nation and reagent waste

Approximate-ly 14 minutes to first result; 4 minutes for each addi-tional

LIS compatible (RS-232) with uni-directional download

Instrument can inter-face direct-ly to the LIS or to POC connectivity middleware (see con-nectivity op-tions)

POC Connectiv-ity Middleware Options: Tel-cor Quick-Linc® and QML®; Med-ical Automation Systems RALS-Plus®

No The SCS is compliant with POCT 1A when interfaced with Tel-cor Quick-Linc® and QML®; Medical Automation Systems RALS-Plus®

N/A Automatic lockout based on QC perfor-mance, oper-ator validation and instru-ment status

The Stratus CS Analyz-er, designed for acute-care diagnostics, is a model of cost-effec-tiveness for both your laboratory and near-patient setting; it’s a random-access ana-lyzer, delivering quanti-tative cardiac markers, BhCG, D-Dimer results from a whole blood sample in as little as 14 minutes; the simple three-step process—load sample and ro-tor, load testpack(s) and press Start— is easy to use by all skill levels

HemoCue Inc.Contact:

(800) 881-1611E-mail:

[email protected] Web Site:

www.hemocue.com

Hb 201+ An-alyzer

Hemoglo-bin testing for point of care

3.35 in x 6.3 in x 1.69 in; .77 lbs


Physician office, hospital, blood bank, dialysis center and pub-lic health


Automatic self-test



Glucose 201 Analyzer

Glucose test-ing

3.35 in x 6.3 in x 1.69 in; .77 lbs



Single analyte Whole blood Wet chemical glucose dehydro-genase

Automatic self-test

5 µl Absorbance pho-tometry; glucose dehydrogenase

40–240 sec-onds

Lab quality results at the point of care; cleared for screening, diagnosing and mon-itoring of diabetes; off meter dosage; mini-mum of interferences; no lot-to-lot varia-tion; no recalibration needed

Hb 201 DM An-alyzer

Hemoglobin testing with data manage-ment features

3.66 in x 6.7 in x 1.97 in; .77 lbs


Hospital Single analyte Whole blood International Ref-erence Method (ICSH)




<1 minute Ethernet or USB to PC or laptop for full bi-direction-al communica-tion providing downloading and configura-tion features



No Yes Yes No Yes; can be superviso-ry locked out using the He-moCue 201 DM PC Soft-ware

Lab quality results at the point of care; measure at two wave-lengths to correct for turbidity; full data, op-erator and analyzer management funtion-ality; minimum of interferences; no lot-to-lot variation; no re-calibration needed



Type of Design

Primary Area of Use
















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HemoCue Inc.(continued)

Glucose 201 DM Analyzer

Glucose test-ing with data management features

3.66 in x 6.7 in x 1.97 in; .77 lbs


Hospital Single analyte Whole blood Wet chemical glucose dehydro-genase



5 µl Absorbance pho-tometry; Glucose dehydrogenase

40–240 sec-onds

Ethernet or USB to PC or laptop for full bi-direction-al communica-tion providing downloading and configura-tion features



No Yes Yes No No Lab quality results at the point of care; cleared for screening, diagnosing and moni-toring of diabetes; full data, operator and an-alyzer management funtionality; off meter dosage; minimum of interferences; no lot-to-lot variation; no re-calibration needed

Plasma/Low Hb Photometer

Plasma hemo-globin testing

6.29 in x 8.25 in x 3.54 in; 2 lbs

Portable; single-use testing: mi-crocuvette

Hospital lab, sur-gery and blood banks

Single analyte Plasma, serum, aqueous so-lutions, stored blood

International Ref-erence Method (ICSH)

Liquid controls available



Donor Hb Checker Pho-tometer

Hemoglo-bin testing for blood donor screening

6.29 in x 8.25 in x 3.54 in; 2 lbs


Blood donor col-lection facilities


Control cuvette to verify cali-bration

10 µl Absorbance pho-tometry; measures the absorbance of hemolyzed blood at the Hb/HbO2 isobestic point


Albumin 201 Analyzer (pend-ing FDA clear-ance)

Microalbunin-uria screen-ing for point of care

6.89 in x 2.56 in x 4.53 in; .77 lbs



Single analyte Urine Tubidimetric method using CRM 470 (cert-fied reference material)

Automatic self-test

18 µl Absorbance pho-tometry; immmuno chemical reaction

<90 seconds Lab-quality results at the point of care; for screening, diagnosing and monitoring for mi-croalbuminuria

HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134

Contact: Tim Still, EVP Sales & Marketing; 408-719-1393 fax: 408-719-1184


Web Site: www.hemosense.com

INRatio PT/INR Monitoring Sys-tem

Prothrombin Time/INR

6.125 x 3 x 2.2 in / 155.6 x 76 x 55.8 mm / 8.1 oz. / 229g / MSRP $1,595 POC; $1,995 Pa-tient Self Test

Portable size, single strip use

Point-of-Care Testing

PT, INR Fingerstick blood Calibrated to WHO standards

2 levels of quantitative QC onboard with reportable re-sults

1 drop ~15µL fresh whole capil-lary blood

Electrochemical impedance based

<2 minutes Yes, export re-sults to printer or software

RS232 cable Data Port to con-nect to computer or printer

Yes 2 levels of quantita-tive QC onboard with results displayed; test strip storage non-re-frigerated up to 12 months; no exter-nal or liquid controls required; no special blood collection devic-es required; individual-ly packaged strips

Inverness Medical Professional Diagnostics

(800) 637-3717Web site: www.invernessmedicalpd.com

PocketChemTM UA Compact Urine Alyzer

Ultra-porta-ble Urine Strip Reader

9x5x1 inches, 1.5 lbs/

reflectance spectropho-tometry

Nursing units, ED/ER, laborato-ry, POL

Glucose, Protein, Blood, Nitrites, pH, Urobilino-gen, Ketones, Bilirubin, Leuko-cytes, Specific Gravity

Urine Glucose - double sequential en-zyme Protein - protein error reaction Bilirubin - Azo coupling Urobilinogen - Azo coupling pH - mixed pH indicator S.G. - cation ex-traction Blood - pseudo-peroxidase Ketone - Legal reaction Nitrite - Griess reaction Leukocytes - es-terase activity

Exterl QC ma-terial, also HCG pos

Option to input measurement and PT ID

Enough to cover all pads

Triple wavelength, dedicated LED

60 seconds RS-232 inter-face

External RS-232 interface None Pocket sized; automatic correction for pH; automatic correction for temp; automatic compensa-tion for color; automatic calibration with standard pad; allows for left or right-handed setup

AcceavaTM H. pylori

lateral flow ICT


H. pylori rap-id test

Whole blood, se-rum, plasma

Onboard proce-dural control


10 ul for se-rum/plas-ma 25 ul for whole blood

Detection of IgG, IgA, and IgM anti-bodies to H. pylori

10 minutes Detection of IgG, IgA, and IgM antibodies; 95.9% sensitivity; 89.1% specificity

Clearview H. pylori

lateral flow ICT




1 drop (~20 ul) serum/plasma 2 drops (~40 ul) whole blood

Detection of IgG antibodies to H. pylori

1 to 5 minutes 92.6% sensitivity; 82.4% specificity

ImmunoCar-dSTAT! Rota-virus

lateral flow ICT


Rotavirus rap-id test

Stool 25 ul Detection of Group A Rotavirus antigen in stool

10 minutes Easy, clean procedure; 93.1% sensitivity; 95.8% specificity

BioStar OIA Cd-TOX A

Optical Im-munoassay


Clostridium difi-cile toxin A rap-id test

Stool Onboard proce-dural control

Scrape with sam-ple brush or 220 ul liquid stool

Detection of CD Tox A enterotoxin

15 minutes Easy, clean procedure

Clearview Cd-TOX A

lateral flow ICT



Stool 125 ul stool filtrate


30 minutes



Type of Design

Primary Area of Use
















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| s t o r y tA g L i n e |

HemoCue Inc.(continued)

Glucose 201 DM Analyzer

Glucose test-ing with data management features

3.66 in x 6.7 in x 1.97 in; .77 lbs


Hospital Single analyte Whole blood Wet chemical glucose dehydro-genase



5 µl Absorbance pho-tometry; Glucose dehydrogenase

40–240 sec-onds

Ethernet or USB to PC or laptop for full bi-direction-al communica-tion providing downloading and configura-tion features



No Yes Yes No No Lab quality results at the point of care; cleared for screening, diagnosing and moni-toring of diabetes; full data, operator and an-alyzer management funtionality; off meter dosage; minimum of interferences; no lot-to-lot variation; no re-calibration needed

Plasma/Low Hb Photometer

Plasma hemo-globin testing

6.29 in x 8.25 in x 3.54 in; 2 lbs


Hospital lab, sur-gery and blood banks

Single analyte Plasma, serum, aqueous so-lutions, stored blood

International Ref-erence Method (ICSH)

Liquid controls available



Donor Hb Checker Pho-tometer

Hemoglo-bin testing for blood donor screening

6.29 in x 8.25 in x 3.54 in; 2 lbs


Blood donor col-lection facilities


Control cuvette to verify cali-bration

10 µl Absorbance pho-tometry; measures the absorbance of hemolyzed blood at the Hb/HbO2 isobestic point


Albumin 201 Analyzer (pend-ing FDA clear-ance)

Microalbunin-uria screen-ing for point of care

6.89 in x 2.56 in x 4.53 in; .77 lbs



Single analyte Urine Tubidimetric method using CRM 470 (cert-fied reference material)

Automatic self-test

18 µl Absorbance pho-tometry; immmuno chemical reaction

<90 seconds Lab-quality results at the point of care; for screening, diagnosing and monitoring for mi-croalbuminuria

HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134

Contact: Tim Still, EVP Sales & Marketing; 408-719-1393 fax: 408-719-1184


Web Site: www.hemosense.com

INRatio PT/INR Monitoring Sys-tem

Prothrombin Time/INR

6.125 x 3 x 2.2 in / 155.6 x 76 x 55.8 mm / 8.1 oz. / 229g / MSRP $1,595 POC; $1,995 Pa-tient Self Test

Portable size, single strip use

Point-of-Care Testing

PT, INR Fingerstick blood Calibrated to WHO standards

2 levels of quantitative QC onboard with reportable re-sults

1 drop ~15µL fresh whole capil-lary blood

Electrochemical impedance based

<2 minutes Yes, export re-sults to printer or software

RS232 cable Data Port to con-nect to computer or printer

Yes 2 levels of quantita-tive QC onboard with results displayed; test strip storage non-re-frigerated up to 12 months; no exter-nal or liquid controls required; no special blood collection devic-es required; individual-ly packaged strips

Inverness Medical Professional Diagnostics

(800) 637-3717Web site: www.invernessmedicalpd.com

PocketChemTM UA Compact Urine Alyzer

Ultra-porta-ble Urine Strip Reader

9x5x1 inches, 1.5 lbs/

reflectance spectropho-tometry


Glucose, Protein, Blood, Nitrites, pH, Urobilino-gen, Ketones, Bilirubin, Leuko-cytes, Specific Gravity

Urine Glucose - double sequential en-zyme Protein - protein error reaction Bilirubin - Azo coupling Urobilinogen - Azo coupling pH - mixed pH indicator S.G. - cation ex-traction Blood - pseudo-peroxidase Ketone - Legal reaction Nitrite - Griess reaction Leukocytes - es-terase activity

Exterl QC ma-terial, also HCG pos


Enough to cover all pads

Triple wavelength, dedicated LED

60 seconds RS-232 inter-face

External RS-232 interface None Pocket sized; automatic correction for pH; automatic correction for temp; automatic compensa-tion for color; automatic calibration with standard pad; allows for left or right-handed setup

AcceavaTM H. pylori

lateral flow ICT




Onboard proce-dural control


10 ul for se-rum/plas-ma 25 ul for whole blood

Detection of IgG, IgA, and IgM anti-bodies to H. pylori

10 minutes Detection of IgG, IgA, and IgM antibodies; 95.9% sensitivity; 89.1% specificity

Clearview H. pylori

lateral flow ICT




1 drop (~20 ul) serum/plasma 2 drops (~40 ul) whole blood

Detection of IgG antibodies to H. pylori

1 to 5 minutes 92.6% sensitivity; 82.4% specificity

ImmunoCar-dSTAT! Rota-virus

lateral flow ICT


Rotavirus rap-id test

Stool 25 ul Detection of Group A Rotavirus antigen in stool

10 minutes Easy, clean procedure; 93.1% sensitivity; 95.8% specificity

BioStar OIA Cd-TOX A




Stool Onboard proce-dural control

Scrape with sam-ple brush or 220 ul liquid stool


15 minutes Easy, clean procedure

Clearview Cd-TOX A

lateral flow ICT



Stool 125 ul stool filtrate


30 minutes



Type of Design

Primary Area of Use
















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Inverness Medical Professional Diagnostics(continued)

Clearview UL-TRA FOB

Lateral flow ICT


Rapid immuno-assay for Fecal Occult Blood

Stool onboard proce-dural control

scrape with sample probe

specific for human hgb in stool

1-5 minutes Easy, clean procedure; specific for human hgb; no dietary restrictions; 50 ng limit of de-tection; 99.3% sensitivity; 98.9% accuracy; separate PT take; home sample kits

STREP A OIA MAX


Microbiology Throat swab Positive and negative con-trols in kit

Immunoassay 5 minutes Yes Yes

Acceava GAS Lateral flow ICT



Clearview Exact Strep A

Lateral flow ICT



NOW Strep A Lateral flow ICT, Clam-shell



BioStar OIA FLU Optical Im-munoassay

Microbiology NP Swab, sal As-pirate, Throat Swab, Sputum

Positive and negative con-trols in kit


BioStar OIA FLU A/B





BinaxNOW Influ-enxa A&B

Lateral flow ICT, Clam-shell

Microbiology NP Swab, sal Wash



Clearview Mono Lateral flow ICT

Microbiology Plasma, Serum, Whole Blood



Acceava Mono Lateral flow ICT




Clearview D-Dimer

Lateral flow ICT

Microbiology Whole blood, Plasma


Immunoassay Yes Yes

Legionella Uri-nary Antigen test


Hospital/refer-ence lab

Urine Culture

Streptococcus pneumoniae An-tigen test



Urine/CSF Blood Culture

Influenza A & B Combo test (Moderately Complex)



Culture/DFA

Nanogen Inc.

Contact: Nancy T. Rector(416) 798-0631


Web Site: www.nanogen.com

i-Lynx™ System

Data Capture Device

Device: 8 in x 7.5 in x 4.6 in; Dock-ing Station: 9.25 in x 5 in x 4.25 in; List $5,600

Handheld Emergency de-partment or laboratory/cardi-ologist office

Cardiac markers Open architecture Kit related Opera-tor lockout timed assay mode

Kit related Kit related 5-15 minutes Yes Yes LAN, TCPIP, USB Future ca-pability

Yes Yes Yes Yes QC and operator data capture • Software compatible and connectivity ready with POC industry soft-ware solutions • Security log in and lockout features • Instant or multi test mode to allow for high throughput • Hand-held device for testing at the patient bedside • True walk away mode or instant multi-test option • Easy to use PDA-style touch screen • Integrated universal barcode scanner • Docking station built-in printer

Cardi-ac STATus™ Myoglobin/Tro-ponin I, CKMB Cardiac Mark-ers

Lateral flow membrane

Tandem (TnI/Myo/CKMB), $51.00

Kit test Emergency de-partment or laboratory/cardi-ologist office

TnI/Myo/CKMB Whole blood, se-rum or plasma

Beckman Ac-cess: TnI Abbott IMX: CKMB Dade Opus: Myoglobin

Internal QC 150 mL of whole blood; serum or plasma

Immunochromato-graphic

5 minutes to a positive; 15 minutes to a negative

When used in conjunc-tion with the i-Lynx™ Sys-tem

When used in conjunc-tion with the i-Lynx™ System

When used in conjunction with the i-Lynx™ System

When used in conjunc-tion with the i-Lynx™System

Quickly and accurate-ly identify heart attacks in patients experienc-ing chest pain with Spectral’s Cardiac STA-Tus™. • Rapid Results— Qualitative cardiac marker results in 15 minutes without instru-mentation



Type of Design

Primary Area of Use
















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Inverness Medical Professional Diagnostics(continued)

Clearview UL-TRA FOB

Lateral flow ICT


Rapid immuno-assay for Fecal Occult Blood

Stool onboard proce-dural control

scrape with sample probe

specific for human hgb in stool

1-5 minutes Easy, clean procedure; specific for human hgb; no dietary restrictions; 50 ng limit of de-tection; 99.3% sensitivity; 98.9% accuracy; separate PT take; home sample kits

STREP A OIA MAX




Acceava GAS Lateral flow ICT



Clearview Exact Strep A

Lateral flow ICT



NOW Strep A Lateral flow ICT, Clam-shell



BioStar OIA FLU Optical Im-munoassay




BioStar OIA FLU A/B





BinaxNOW Influ-enxa A&B


Microbiology NP Swab, sal Wash



Clearview Mono Lateral flow ICT




Acceava Mono Lateral flow ICT




Clearview D-Dimer

Lateral flow ICT

Microbiology Whole blood, Plasma


Immunoassay Yes Yes

Legionella Uri-nary Antigen test



Urine Culture

Streptococcus pneumoniae An-tigen test



Urine/CSF Blood Culture

Influenza A & B Combo test (Moderately Complex)



Culture/DFA

Nanogen Inc.

Contact: Nancy T. Rector(416) 798-0631


Web Site: www.nanogen.com

i-Lynx™ System

Data Capture Device

Device: 8 in x 7.5 in x 4.6 in; Dock-ing Station: 9.25 in x 5 in x 4.25 in; List $5,600

Handheld Emergency de-partment or laboratory/cardi-ologist office

Cardiac markers Open architecture Kit related Opera-tor lockout timed assay mode

Kit related Kit related 5-15 minutes Yes Yes LAN, TCPIP, USB Future ca-pability

Yes Yes Yes Yes QC and operator data capture • Software compatible and connectivity ready with POC industry soft-ware solutions • Security log in and lockout features • Instant or multi test mode to allow for high throughput • Hand-held device for testing at the patient bedside • True walk away mode or instant multi-test option • Easy to use PDA-style touch screen • Integrated universal barcode scanner • Docking station built-in printer

Cardi-ac STATus™ Myoglobin/Tro-ponin I, CKMB Cardiac Mark-ers

Lateral flow membrane

Tandem (TnI/Myo/CKMB), $51.00


TnI/Myo/CKMB Whole blood, se-rum or plasma

Beckman Ac-cess: TnI Abbott IMX: CKMB Dade Opus: Myoglobin







When used in conjunc-tion with the i-Lynx™System

Quickly and accurate-ly identify heart attacks in patients experienc-ing chest pain with Spectral’s Cardiac STA-Tus™. • Rapid Results— Qualitative cardiac marker results in 15 minutes without instru-mentation



Type of Design

Primary Area of Use
















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Nanogen Inc.(continued)

• Time critical diag-nostic information, in accordance with AHA and ACC guidelines • Stored at room tem-perature • Easy to use—No de-capping• Simple to read • Utilizes the re-nowned 8I-7 antibody in a sandwich assay for superior Troponin I• Capture and avoids interfering factors

Cardi-ac STATus™ Myoglobin/Troponin I Cardiac Mark-ers

Lateral Flow Membrane

TnI/ Myo, $40.80


Troponin I/Myo-globin

Whole blood, se-rum or plasma

Beckman Ac-cess: TnI Dade Opus: Myo-globin








See above

Cardi-ac STATus™ Troponin I Car-diac Marker


TnI $35.70 / kit


Troponin I Whole blood, se-rum or plasma

Beckman Ac-cess: TnI








See above

Nova Biomedical Contact:

Harlan Polishook (781) 894-0800


Web Site: www.novabiomedical.com

Stat Profile Criti-cal Care Xpress

Blood gas/electrolyte/chemistry

17.2 in x 22.3 in x 17.3 in, 53 lbs; $25,000–$59,000

Transportable, multi-use, microsensor-based

Laboratory, re-spiratory care, ICU, OR, ED

pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, Glucose, Lac-tate, BUN, Cre-atinine, HHb, O2Hb, MetHb, COHb


Conforms to ac-cepted laboratory standards from a variety of industry organizations

Onboard liquid QC; QC lock-out; ability to store, date, time stamp, print pa-tient and QC re-sults

Multiple lay-er; user con-figurable, including pa-tient ID, medical record number, operator ID, PIN number

60-210 mi-croliters (de-pending on menu se-lected)

pH, Na+, K+, Cl, Ca++, Mg++ — Direct ISE; glucose, lactate, creati-nine — enzyme/amperometric; PCO2 —Sever-inghaus; PO2 — amperometeric; SO2%— optical, reflectance; Hct — conductivity; Hb — multi-wavelength, reflectance; BUN — enzyme/direct ISE; HHb, O2Hb, MetHb, COHb -- spectophotometry

62 seconds (high through-put); 134 sec-onds (routine throughput)

“Unlimited” pa-tient and QC database on-board that is download-able or direct connected to LIS/HIS

Yes TCP/IP; Ether-net; USB; RF net-works; serial RS-232; bi-direc-tional communi-cations; remote control for cal-ibrations; QC, maintenance and troubleshooting; remote review of results prior to release

Yes Stat Pro-file Criti-cal Care Xpress

Yes Yes Yes Color touch screen; in-tegrated co-oximeter; open software archi-tecture; onboard data management; auto-mated, onboard quality control; sealed waste system; auto-monitor-ing of QC and reagent packs; tankless gas calibration; automated maintenance

Radiometer America Inc.

Contact: (440) 871-8900


Web Site: www.radiometeramerica.com

ABL80 FLEX Blood gas, electrolytes and glucose

16 in x 9 in x 11 in

Portable with built-in bat-tery; car-tridge-based consumable; no user main-tenance

CVOR, OR, ICU, ER, NICU, re-spiratory de-partments, laboratory

pH, pO2, pCO2, Ca++, Cl-, K+, Na+, Hct, cGlu

Heparinized, whole blood

Validated to IFCC guidelines

Automatic, on-board QC sys-tem with automatic lock-out for parame-ter that fails

5 user-defined access levels

70 uL See reference manual

120 seconds Wireless, on-board CD R/RW drive

Yes ASTM, HL7, TCP/IP, POCT-1A

Yes Yes Yes Yes Yes Part of Radiometer’s first automatic blood gas analysis system that uses pre-bar-coded samplers and FLEXLINK software to ensure accurate pa-tient and sample iden-tification; portable mixing device ensures fast and complete mix-ing prior to analysis

NPT7 Blood gas and CO-oximetry

10 in x 13 in x 17 in


ICU, ER, re-spiratory de-partments, laboratory

pO2, pCO2, pH, tHb, O2Hb, metHb, HHb



QualityGuard System au-tomatically checks analyzer and each sam-ple cuvette be-fore and during analysis

User logon, manager as-signs levels of access, QC lockout, result repression

90 uL Patented optical technology; mea-surements are achieved through technologies of modulation, infra-red spectroscopy, 128-wavelength spectroscopy and phosphorescence quenching

Approx. 1 minute

Built-in PCMCIA memory card, Ethernet and serial interface to LIS and all external data management systems. RA-DIANCE STAT Analyzer Man-agement Sys-tem.

Both ASTM Serial and Ethernet

No Yes, with RADIANCE STAT Ana-lyzer Man-agement System

Yes Yes Yes, with RA-DIANCE STAT Analyzer Management System

The only discrete car-tridge-based blood gas analyzer on the mar-ket to verify the perfor-mance of the cartridge prior to analysis; Qual-ityGuard QC system; battery operation; three-month in-use cartridge life; minimal waste; full CO-Oxim-tery panels with each blood gas; mainte-nance free

Response Biomedical Corp. Contact:

(604) 456-6010; Toll Free: (888) 591-5577


Web Site: www.responsebio.com

RAMP Rapid Ana-lyte Measure-ment Platform (RAMP)—A Fluorescence Reader

27 cm (11”) wide x 25 cm (10”) deep x 15 cm (6”) high; Weight: 4.6 lbs

Quantitative Immunochro-matographic Analyzer

Point of care—emergency de-partment

Currently avail-able: Tropo-nin I, CK-MB and Myoglobin. Coming in 2006: Nt-ProBNP (un-der license from Roche). Under development: Flu A, Flu B and RSV

Whole blood System QC Fully program-mable self di-agnostics (IQC), lot verifica-tion and expi-ry information for up to 50 as-say lots; pow-er-on self-tests include: calibra-tion verification, clock, trans-port mecha-nism, optics function and re-chargeable bat-tery test

Supervisor-con-trolled functions such as oper-ator lists and lockout, QC in-terval, IQC in-terval and internal clock; barcode wand data entry for patient ID and user ID

70 µL Approx. 15 minutes

Assay results can be down-loaded to print-er or PC

PC, printer, reader-to-reader

Download results to PC or via Tel-cor for POC or LIS connectivity

Yes Yes Quantitative, rapid, with <10% CVs across assay ranges; very sensitive Troponin I as-say; discrete cartridge system for running only those tests re-quested; low cost per test, portable, ambula-tory, barcode wand for patient and operator ID entry, 500 patient re-sults and 250 user ca-pacity



Type of Design

Primary Area of Use
















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Nanogen Inc.(continued)

• Time critical diag-nostic information, in accordance with AHA and ACC guidelines • Stored at room tem-perature • Easy to use—No de-capping• Simple to read • Utilizes the re-nowned 8I-7 antibody in a sandwich assay for superior Troponin I• Capture and avoids interfering factors

Cardi-ac STATus™ Myoglobin/Troponin I Cardiac Mark-ers


TnI/ Myo, $40.80


Troponin I/Myo-globin

Whole blood, se-rum or plasma

Beckman Ac-cess: TnI Dade Opus: Myo-globin








See above

Cardi-ac STATus™ Troponin I Car-diac Marker


TnI $35.70 / kit


Troponin I Whole blood, se-rum or plasma

Beckman Ac-cess: TnI








See above

Nova Biomedical Contact:

Harlan Polishook (781) 894-0800


Web Site: www.novabiomedical.com

Stat Profile Criti-cal Care Xpress

Blood gas/electrolyte/chemistry

17.2 in x 22.3 in x 17.3 in, 53 lbs; $25,000–$59,000

Transportable, multi-use, microsensor-based

Laboratory, re-spiratory care, ICU, OR, ED

pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, Glucose, Lac-tate, BUN, Cre-atinine, HHb, O2Hb, MetHb, COHb


Conforms to ac-cepted laboratory standards from a variety of industry organizations

Onboard liquid QC; QC lock-out; ability to store, date, time stamp, print pa-tient and QC re-sults

Multiple lay-er; user con-figurable, including pa-tient ID, medical record number, operator ID, PIN number

60-210 mi-croliters (de-pending on menu se-lected)

pH, Na+, K+, Cl, Ca++, Mg++ — Direct ISE; glucose, lactate, creati-nine — enzyme/amperometric; PCO2 —Sever-inghaus; PO2 — amperometeric; SO2%— optical, reflectance; Hct — conductivity; Hb — multi-wavelength, reflectance; BUN — enzyme/direct ISE; HHb, O2Hb, MetHb, COHb -- spectophotometry

62 seconds (high through-put); 134 sec-onds (routine throughput)

“Unlimited” pa-tient and QC database on-board that is download-able or direct connected to LIS/HIS

Yes TCP/IP; Ether-net; USB; RF net-works; serial RS-232; bi-direc-tional communi-cations; remote control for cal-ibrations; QC, maintenance and troubleshooting; remote review of results prior to release

Yes Stat Pro-file Criti-cal Care Xpress

Yes Yes Yes Color touch screen; in-tegrated co-oximeter; open software archi-tecture; onboard data management; auto-mated, onboard quality control; sealed waste system; auto-monitor-ing of QC and reagent packs; tankless gas calibration; automated maintenance

Radiometer America Inc.

Contact: (440) 871-8900


Web Site: www.radiometeramerica.com

ABL80 FLEX Blood gas, electrolytes and glucose

16 in x 9 in x 11 in


CVOR, OR, ICU, ER, NICU, re-spiratory de-partments, laboratory

pH, pO2, pCO2, Ca++, Cl-, K+, Na+, Hct, cGlu



Automatic, on-board QC sys-tem with automatic lock-out for parame-ter that fails

5 user-defined access levels

70 uL See reference manual

120 seconds Wireless, on-board CD R/RW drive

Yes ASTM, HL7, TCP/IP, POCT-1A

Yes Yes Yes Yes Yes Part of Radiometer’s first automatic blood gas analysis system that uses pre-bar-coded samplers and FLEXLINK software to ensure accurate pa-tient and sample iden-tification; portable mixing device ensures fast and complete mix-ing prior to analysis

NPT7 Blood gas and CO-oximetry

10 in x 13 in x 17 in


ICU, ER, re-spiratory de-partments, laboratory

pO2, pCO2, pH, tHb, O2Hb, metHb, HHb



QualityGuard System au-tomatically checks analyzer and each sam-ple cuvette be-fore and during analysis

User logon, manager as-signs levels of access, QC lockout, result repression

90 uL Patented optical technology; mea-surements are achieved through technologies of modulation, infra-red spectroscopy, 128-wavelength spectroscopy and phosphorescence quenching

Approx. 1 minute

Built-in PCMCIA memory card, Ethernet and serial interface to LIS and all external data management systems. RA-DIANCE STAT Analyzer Man-agement Sys-tem.

Both ASTM Serial and Ethernet

No Yes, with RADIANCE STAT Ana-lyzer Man-agement System

Yes Yes Yes, with RA-DIANCE STAT Analyzer Management System

The only discrete car-tridge-based blood gas analyzer on the mar-ket to verify the perfor-mance of the cartridge prior to analysis; Qual-ityGuard QC system; battery operation; three-month in-use cartridge life; minimal waste; full CO-Oxim-tery panels with each blood gas; mainte-nance free

Response Biomedical Corp. Contact:

(604) 456-6010; Toll Free: (888) 591-5577


Web Site: www.responsebio.com

RAMP Rapid Ana-lyte Measure-ment Platform (RAMP)—A Fluorescence Reader

27 cm (11”) wide x 25 cm (10”) deep x 15 cm (6”) high; Weight: 4.6 lbs

Quantitative Immunochro-matographic Analyzer

Point of care—emergency de-partment

Currently avail-able: Tropo-nin I, CK-MB and Myoglobin. Coming in 2006: Nt-ProBNP (un-der license from Roche). Under development: Flu A, Flu B and RSV

Whole blood System QC Fully program-mable self di-agnostics (IQC), lot verifica-tion and expi-ry information for up to 50 as-say lots; pow-er-on self-tests include: calibra-tion verification, clock, trans-port mecha-nism, optics function and re-chargeable bat-tery test

Supervisor-con-trolled functions such as oper-ator lists and lockout, QC in-terval, IQC in-terval and internal clock; barcode wand data entry for patient ID and user ID

70 µL Approx. 15 minutes

Assay results can be down-loaded to print-er or PC

PC, printer, reader-to-reader

Download results to PC or via Tel-cor for POC or LIS connectivity

Yes Yes Quantitative, rapid, with <10% CVs across assay ranges; very sensitive Troponin I as-say; discrete cartridge system for running only those tests re-quested; low cost per test, portable, ambula-tory, barcode wand for patient and operator ID entry, 500 patient re-sults and 250 user ca-pacity



Type of Design

Primary Area of Use
















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Company Info Product Name QC Features Distinguishing Features

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Response Biomedical Corp. (continued)

Software QC unauthorized user lock-out; external QC overdue result flag; patient re-sults output includes: pa-tient result, pa-tient ID, user ID, date, time, lot number, serial number

Test Cartridge QC Each test car-tridge uses an internal con-trol zone and the RAMP Ratio for calibrating each test. This process miti-gates variabili-ty and reduces CV’s. Each car-tridge is bar coded with lot expiry and as-say information. Multiple safe-guards to miti-gate procedural errors.

Security Fea-tures: Supervi-sor-controlled functions such as operator lists and lockout, QC interval, IQC in-terval and in-ternal clock. Barcode Wand data entry for patient ID and user ID.

RNA Medical; A Division of Bionostics Inc.

Contact: Paul F. Shea

Phone: 978-772-9070

Fax: 978-772-9071


Web Site: www.RNAMedical.com

Blood gas qual-ity and linear-ity controls; diabetes quali-ty and linearity controls; he-matology and urinalysis con-trols

PeerQC gives the end user the opportuni-ty to record the data and re-ceive a peer comparison within a few minutes

RNA Medical offers differentiated QC so-lutions for your POC market

Roche Diagnostics

9115 Hague RoadIndianapolis, IN 46256

Contact:Ben GreenfieldMarketing Manager

Phone:(317) 521-3088

Web Site:www.roche-diagnostics.us

Documents

POCT - advanceweb.com · 78 | advance/Laboratory • April 2006 POCT Company Info Product Name Type of Analyzer Size and Weight/Cost Type of Design Primary Area