2011 POCT BUYERS GUIDE 2011 ANNUAL POCT - Advance€¦ · ANNUAL POCT BUYERS GUIDE 2011 ......

2011 POCT BUYERS GUIDE

50 MARCH 2011 • ADVANCE /LABORATORY • WWW.ADVANCEWEB.COM

ANNUAL POCTBUYERS GUIDE

2011

COMPANY PRODUCT TYPE OF ANALYZER/ASSAY TEST MENU SAMPLE TYPE/SIZE

Alere Inc.(800) 441-7440www.alere.com

Acceava, Alere, BinaxNOW, Clearview, MeterPro and Triage are trademarks of the Alere group of companies. STAT-PAK is a trademark of Chembio Diagnostic Systems, Inc, under license. All other trademarks referenced are trademarks of their respective owners.

Acceava® H. pylori POC rapid test; lateral flow ICT Lateral flow ICT 10 µL serum/ plasma; 25 µL whole blood

Acceava® hCG POC rapid test; three different formats: hCG Basic II, hCG Urine II, hCG Combo II

Lateral flow ICT ~100 µL urine (K10 or serum)

Acceava® Mono Cassette POC rapid test Lateral fl ow ICT Plasma, serum, whole blood

Acceava® Mono II POC rapid test Lateral fl ow ICT Plasma, serum, whole blood

Acceava® Strep A POC rapid test; lateral flow ICT (two formats: dipstick or twist)

Lateral fl ow ICT Throat swab

Alere Triage® MeterPro®, Alere Triage® Drugs of Abuse panel, Alere Triage® C. difficile panel, Alere Triage® Triage Parasite panel, Alere Triage® TOX Drug Screen Alere Triage® D-Dimer, Alere Triage® BNP, Alere Triage® Cardiac Panel, Alere Triage® Cardio ProfilER, Alere Triage® Profiler SOB

Portable meter platform (not applicable to DOA panels); 8.5” x 6.25” x 2.75”; 1.5 lbs.; immunofluorescence

BNP, CK-MB, Myoglobin, Troponin I, D-Dimer, myoglobin, troponin, acetaminophen*, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, PCP, propoxyphene**, THC, tricyclic antidepressants (*Triage Meter only; **Triage DOA Panel)

Varies by product, EDTA, whole blood, plasma or urine; 250 mL

Alere™ PBP2a POC rapid test; lateral flow ICT Lateral fl ow ICT S. aureus isolate

BinaxNOW® Influenza A&B POC rapid test; lateral flow ICT Lateral fl ow ICT, card test NP swab, nasal wash/aspirate, nasal swab

BinaxNOW® Legionella Urinary Antigen test

POC rapid test; lateral flow ICT Lateral fl ow ICT, card test Urine

BinaxNOW® Malaria POC rapid test; lateral flow ICT Lateral fl ow ICT, card test 15 µL whole blood

BinaxNOW® RSV POC rapid test; lateral flow ICT Lateral fl ow ICT, card test NP swab, nasal wash

BinaxNOW® Strep A POC rapid test; lateral flow ICT Lateral fl ow ICT, card test Throat swab

C. DIFF QUIK CHEK COMPLETE® POC rapid test Up fl ow membrane 25 µL feces

C. DIFF QUIK CHEK® POC rapid test Up fl ow membrane 25 µL feces

Clearview® RUBELLA-plus® POC rapid test; lateral flow ICT Lateral fl ow ICT 10 µL serum or plasma samples

Clearview® Chlamydia POC rapid test; lateral flow ICT Lateral fl ow ICT Female cervical swab

AL030711_edit_CUT.indd 50AL030711_edit_CUT.indd 50 3/8/11 2:20:23 PM3/8/11 2:20:23 PM

WWW.ADVANCEWEB.COM • ADVANCE /LABORATORY • MARCH 2011 51

EDITOR'S NOTE: ADVANCE for Administrators of the Laboratory is proud to offer the 2011 Annual

Point-of-Care Testing Buyers Guide. The easy-to-read chart identifi es point-of-care testing

manufacturers and provides information about their devices, analyzers and/or assays.

ADVANCE relies on its readership to improve the quality of special sections. If you fi nd this guide

useful or if you have suggestions, please send a publishable letter to Editor Lynn Nace at lnace@

advanceweb.com.

Company and product inclusion does not represent endorsement by ADVANCE.

PRODUCT REFERENCE METHODS QC FEATURES SECURITY FEATURES TURNAROUND TIME DOWNLOADING CAPABILITIES/CONNECTIVITY OPTIONS

Helicobacter pylori Onboard procedural control; positive and negative controls available

EQC lockout; patient ID; operator ID

10 minutes Connectivity available through third party vendor (Telcor)

hCG , the pregnancy hormone Built-in controls ensure accuracy; positive and negative controls available —

3 minutes (urine), 5 minutes (serum); positive results in as little as 1 minute

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Infectious Mononucleosis Positive and negative controls in kit —

8 minutes—

Infectious Mononucleosis Positive and negative controls in kit —

5 minutes read time —

Group A Streptococcus Positive and negative controls in kit; onboard procedural controls —

5 minutes —

Multiple reference methods, varies by product

Internal reactive controls on each cartridge, daily quality control device, internal reference fl uorescent chip, ID and QC lockouts: expiration date lockout, QC performance lockout, internal control lockout

User ID lockouts, supervisor setting lockouts

~15 minutes Comprehensive upload/download capability via our data management solution Triage Census ATM

MRSA Positive and negative control strains sold separately; test strip has built-in internal control —

5 minutes—

Influenza serotype A and B Positive and negative control swabs in kit; QC requirements are once per shipment —

15 minutes—

Legionella Positive and negative control swabs in the kit—

15 minutes —

Differentiates P. falciparum infection from a pan-malarial infection caused by P. vivax, P. ovale or P. malariae

BinaxNOW Malaria Positive Control sold separately—

15 minutes —

Respiratory syncytial virus Positive and negative controls in kit QC requirements are once per shipment —

15 minutes —

Group A Streptococcus Positive and negative controls in kit—

5 minutes —

Clostridium difficile GDH common antigen and toxin A and B rapid test

Onboard procedural control and positive and negative controls with kit —

20 minutes—

Clostridium difficile GDH common antigen Onboard procedural control and positive and negative controls with kit —

20 minutes—

Rubella antibody (IgG) Onboard procedural control—

15 minutes —

Chlamydia trachomatis Positive control in kit; onboard procedural controls—

15 minutes —




Alere Inc.(800) 441-7440www.alere.com(continued...)

Acceava, Alere, BinaxNOW, Clearview, MeterPro and Triage are trademarks of the Alere group of companies. STAT-PAK is a trademark of Chembio Diagnostic Systems, Inc, under license. All other trademarks referenced are trademarks of their respective owners.

Clearview® COMPLETE HIV 1/2 POC rapid test Lateral fl ow Fingerstick & venipuncture whole blood, serum and plasma

Clearview® H. pylori POC rapid test; lateral flow ICT Lateral fl ow ICT 50 µL whole blood, serum or plasma

Clearview® hCG POC rapid test; four different formats: hCG urine dipstick, hCG urine cassette, hCG Combo II and hCG 25 Combo

Lateral fl ow ICT ~100 µL urine (or serum)

Clearview® HIV 1/2 STAT-PAK® POC rapid test; lateral flow ICT Lateral fl ow Fingerstick and venipuncture whole blood, serum and plasma

Clearview® iFOB Complete POC rapid test; lateral flow Lateral fl ow immunochemical test Poke spiral applicator into stool at 6 different sites

Clearview® Mono POC rapid test Lateral fl ow ICT Plasma, serum, whole blood

Clearview® RSV POC rapid test Lateral fl ow ICT NP swab, nasal aspirate

Clearview® Simplify™ D-dimer POC rapid test Lateral fl ow ICT 35 µL whole blood; 20 µL plasma

Clearview® Strep A Exact II POC rapid test; lateral flow ICT (two formats: dipstick or cassette)

Lateral fl ow ICT Throat swab

IBD EZ VUE® POC rapid test; lateral flow ICT Lateral fl ow 50 µL feces

LEUKO EZ VUE™ POC rapid test; lateral flow ICT Lateral fl ow 50 µL feces

TOX A/B QUIK CHEK® POC rapid test Up fl ow membrane 25 µL feces

BiomedicalProducts Corp.(800) 543-7427www.biomedical productscorp.com

hemoChroma POC Hemoglobin Reader

Portable handheld reader; no pipetting necessary

Hemoglobin with calculated Hematocrit 10 uL blood, venous or fingertip

Bio-Rad LaboratoriesClinical Diagnostics Group(800) 2BIO-RADwww.bio-rad.com/diagnostics

TOX/See™

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Oxycodone, buprenorphine, propoxyphene, amphetamines, MDMA, opiates, cocaine, PCP, THC, benzodiazepines, barbiturates, methadone, TCA, methamphetamine

Urine; 3 drops

in2it™

—Hemoglobin A1c Fingerstick and venous whole blood (EDTA, heparin or

fluoride); 10 uL

Multispot® HIV-1/ HIV-2 Rapid Test—

HIV-1 and HIV-2 Serum, plasma; 40 uL

Epocal Inc.(215) 956-9090www.epocal.com

epoc™ Blood Analysis System Blood gasses, electrolytes, metabolytes pH, PCO2, PO2, NA+, K+, Ca++, Glu, Lac, Hct - Measured cTCO2, cHCO3-, BE(ecf), BE(b), cSO2, cHgb - Calculated

Venous or arterial, ~90 microliters

Nova Biomedical(800) 458-5813www.novabiomedical.com

Stat Profile® Critical Care Xpress (CCX)

Blood gas/electrolyte/chemistry; transportable, multi-use, microsensor-based

pH, PCO2, PO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, glucose, lactate, BUN, creatinine, HHb, O2Hb, MetHb, COHb, tBil

Whole blood, serum, plasma (some models); 60-210 microliters depending on menu

StatStrip® Glucose Monitoring System

Handheld, portable POC glucose analyzer Tests measured: Glucose, Hct; Test reported: Glucose

Whole blood (capillary, venous, arterial, neonatal); 1.2 microliters

StatSensor® POC Whole Blood Creatinine and eGFR Testing

Handheld POC creatinine analyzer Creatinine with calculated eGFR Whole blood (capillary, venous, arterial); 1.2 microliters

Stat Profile® pHOx Blood gas/electrolyte/chemistry; transportable, multi-use; microsensor-based

pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Glucose, Lactate

Whole blood, serum/plasma (some models); 45-125 microliters (menu and model dependent)





HIV 1/2 Clearview HIV 1/2 Rapid Test Controls sold separately. Test device includes built-in internal control. —


Helicobacter pylori Positive and negative controls in kit; Onboard procedural controls —

10 minutes —

hCG Built-in controls ensure accuracy; Positive and negative controls available —

3 minutes (urine), 5 minutes (serum); positive results in as little as 1 minute

—

HIV 1/2 Clearview HIV 1/2 Rapid Test Controls sold separately. Test device includes built in internal control. —


Rapid immunoassay for Fecal Occult Blood Positive and Negative Controls sold separately. Test device includes built-in internal control. —

Read results in 5 —

Infectious Mononucleosis Positive and negative controls in kit—

5 minutes read time—

Respiratory syncytial virus Positive and negative controls in kit—

15 minutes—

D-dimer Positive and negative controls in kit—

10 minutes—

Group A Streptococcus Positive and negative controls in kit—

6 minutes—

Elevated lactoferrin as a marker of intestinal inflammation

Onboard procedural controls and positive and negative controls with kit —

30 minutes—

Elevated lactoferrin as a marker of fecal leukocytes


30 minutes—

Clostridium difficile toxin A and toxin B rapid test


30 minutes—

Cyanide free reagent reaction cuvette 0.0-25.6 g/dl or 0-256 g/L

—

<20 seconds Stores up to 1,000 test results

—

Integrated test controls

—

5 minutes

—

Certified by the NGSP to be traceable to the DCCT reference A1C method

Integrated test controls—

10 minutes To PC

—Ready-to-use positive and negative controls and a procedural control spot on each test to assure validity of each run. —

10 minutes—

—

Internal electronic QC on reader, one point liquid QC in each single use test card.

—

~2 minutes after sample injection

Bluetooth communication between host computer and reader, WiFi wireless connection to hospital HIS/LIS. Results transmitted immediately after test completion.

Conforms to accepted laboratory standards from a variety of industry organizations

Onboard automated liquid QC; QC lockout; ability to store, date, time stamp, print patient and QC results

Multiple layer; user-configurable including patient ID; medical record number; operator ID; PIN number

62 seconds (high throughput); 134 seconds (routine throughput)

Unlimited patient and QC database onboard that is downloadable to CD or direct connected to LIS/HIS; TCP/IP; Ethernet; USB, RF Networks; serial RS-232; bi-directional communications; remote control for calibrations; QC, maintenance and troubleshooting; remote review of results prior to release

Conforms to CLSI evaluation protocols Fully customizable for up to three levels of liquid QC to allow for operator lockout at administrator determined times (e.g., prior to patient testing for each shift, every 24 hours, etc.)

Operator and patient ID lockout available

6 seconds Completely bi-directional; interface to most LIS/HIS available with TELCOR Quick-Linc or LDS AegisPOC

—

Fully customizable for up to three levels of liquid QC to allow for operator lockout at administrator determined times (e.g., prior to patient testing, for each shift, every 24 hours, etc.)

Operator and patient ID lockout available

30 seconds Completely bi-directional; interface to most LIS/HIS available with TELCOR Quick-Linc or LDS AegisPOC

Conforms to accepted laboratory standards from a variety of industry organizations

Onboard automated liquid QC, QC lockout, ability to store, date, time stamp, print patient and QC results

Multiple layer; user configurable including patient ID; medical record number; operator ID; PIN number

45 to 52 seconds (depending on test menu)

Unlimited patient and QC database onboard that is downloadable to LIS/HIS; TCP/IP; Ethernet; USB, RF Networks; serial RS-232; bi-directional communications; remote control for calibrations; QC, maintenance and troubleshooting; remote review of results prior to release




Radiometer America(800) 736-0600www.radiometeramerica.com

ABL90 FLEX analyzer; ABL80 FLEX CO-OX analyzer; ABL80 OSM analyzer; safePICO syringe/aspirator

Blood gas and acute care Blood gas, electrolytes, metabolites (glu, lac), CO-oximetry

Syringe, capillary, test tube 16 parameters on 35 microliters (ABL90 FLEX)

Randox Laboratories Ltd.(304) 728-2890www.randox.com

Evidence Multistat Multiplex immunoassay analyzer Amphetamine, Barbiturates, Benzodiazepine 1, Benzodiazepine 2, Buprenorphine, Cannabinoids, Cocaine, metabolite (Benzoylecgonine), MDMA, Methadone, Methamphetamine, Opiates, Phencyclidine Tricyclic Antidepressants (TCAs Generic)

Urine, serum, plasma and whole blood. 7ul

Roche Diagnostics(800) 852-8766www.poc.roche.com

Accutrend(R) Plus system; Accutrend Cholesterol test strips; Accutrend Cholesterol controls; Accutrend Glucose test strips; Accutrend Glucose controls

The Accutrend Plus system is a flexible, handheld device ideal for professional use in non-hospital settings, such as community health screening fairs, physicians' offices, home healthcare agencies and pharmacies

Quantitative measurement of two blood parameters: glucose and cholesterol

Accutrend cholesterol: 15-40 microliters. Accutrend glucose: 15-50 microliters.

Chemstrip urine test strips Chemstrip urine test strips from Roche Diagnostics are protected against vitamin C interference and the possibility of false-negative blood and glucose results; they're designed with an iodate impregnated mesh layer which oxidizes ascorbic acid and removes the interference.

Chemstrip 10 MD, Chemstrip 10SG, Chemstrip 9, Chemstrip 7, Chemstrip 5OB, Chemstrip 2GP, Chemstrip 2LN, Chemstrip uGK, Chemstrip K, Chemstrip Micral

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CoaguChek XS System, CoaguChek XS Plus System and CoaguChek XS Pro System

Quantitatively measures prothrombin (blood clotting) time (PT/Quick Value/INR)

PT/INR testing Capillary blood from fingertip or whole blood from a vein (nonanticoagulated venous whole blood). Sample size for all 3 systems is 8 microliters

Urisys 1100® Urine Analyzer

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Urinalysis testing

—

Sekisui Diagnostics LLC(formerly Genzyme Diagnostics)(800) 332-1042www.sekisuidiagnostics.com

OSOM line of rapid diagnostics tests for family health: C. difficile, Strep A, Mono, Influenza, H. pylori, Microalbumin. Women's Health: Trichomonas, Bacterial Vaginosis, Pregnancy

Lateral flow immunoassay

—

Stool sample for C. difficile Toxin A/B Serum or plasma or whole blood for Mono Urine for hCG Urine and Card Pregnancy Urine or Serum for hCG Combo Throat swab for Strep A Vaginal swab for Trichomonas and BV Nasal swab for Influenza A & B

Siemens Healthcare Diagnostics(877) 885-4873www.usa.siemens.com

DCA Vantage Analyzer; CLIA-waived Clinitek Status+ and Clinitek Status Connect Urine Analyzers

DCA Vantage: Blood glucose analyzer. Clinitek: Urine analyzers.

DCA Vantage: HbA1c and Urine Albumin/Creatinine with A:C Ratio. Clinitek: Multistix 10SG routine urine strip with bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specifi c gravity and urobilinogen; Multistix PRO test strip for testing patients at risk for kidney disease for protein low, protein high, creatinine, protein-to-creatinine ratio, blood, glucose, ketone, leukocytes, nitrite, pH, specifi c gravity; Clinitek Microalbumin 2 test strip for early detection of kidney disease with albumin, creatinine, albumin-to-creatinine ratio; Clinitest hCG pregnancy test for detecting Human Chorionic Gonadotropin (hCG).

DCA Vantage: HbA1c - 1 uL; Albumin - 3.5 uL. Clinitek: All four reagents require a urine sample Multistix 10SG, Multistix PRO, and Clinitek Microalbumin 2 reagent strips require enough urine for complete immersion of all of the reagent pads on the strips Clinitest hCG pregnancy test requires 200 uL of urine.

TrimGen Corp.(410) 472-1100www.trimgen.com

Mutation detection in the EGFR signaling pathway, infectious disease detection as well as warfarin and plavix genotyping.

Capillary electrophoresis, real-time PCR, colorimetric plate reader detection.

KRAS, BRAF, PIK3CA, Enterovirus, Herpes Simplex, Shiga-toxin, C-Diffi cile, West Nile Virus, Warfarin, Plavix and more

Tissue, blood, buccal, CSF and any extracted DNA samples.





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Automatic QC

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ABL90 FLEX: 35 seconds. ABL80 Series: 100 seconds

ABL90 FLEX: ASTM, HL7, POCT1-A standard protocols for HIS, LIS and middleware. ABL80 Series: RADIANCE middleware.

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Controls and calibrators used Password protected Less than 20 minutes for multiple results

Multiple

Accutrend Cholesterol: Hitachi CHOD-PAP. Accutrend Glucose: Hitachi Glucoquant, hexokinase.

Integrated control functions: automatic check of the electronic components and functions when the instrument is powered on; automatic check of the ambient temperature before and during measurement; automatic check of the test strip to ensure that the code information necessary for measurement is in memory; check of the optical system and overall function by means of control solutions.

In certain circumstances, an error message may appear on the display alerting the user that a problem has been detected with the instrument or the way the test has been conducted. User should consult the Users Manual for resolution, or contact Technical Assistance at (800) 440-3638.

Accutrend Cholesterol: 180 seconds. Accutrend Glucose: 12 seconds.

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—

For urine analyzers: Commercial control materials may be used for quality control. For visual use: Quality control for this procedure consists of following good lab techniques and ensuring that reagents have been properly stored and specimens handled according to instructions. —

One minute

—

Products are referenced to Lab (Dade Innovin) in strip package insert.

CoaguChek XS System features onboard controls, no need to run liquid quality controls. CoaguChek XS Plus and CoaguChek XS Pro systems offer optional 2-level liquid quality contols.

CoaguChek XS Plus and CoaguChek XS Pro offer ability to set quality control lockouts, and ability to set operator lockouts with optional data management system.

<1 minute for test results The CoaguChek XS Plus and CoaguChek XS Pro offer connectivity and data management.

Reflectance photometer Commercial control material may be used for quality control. Please contact Roche Diagnostics Technical Service at (800) 428-4674 for recommended control solutions. Positive and negative controls must be tested daily, when a new vial of strips is opened (including every lot change), or whenever calibration is performed.

An error message may appear on the display if the analyzer has detected a problem or the test has not been conducted properly. In this case, the user should consult the Operator's Manual or contact Technical Service.

One minute The Urisys 1100 urine analyzer has a serial interface through which it can be connected to a PC or central host computer.

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Strep A, Ultra Strep A (50 test), Mono and C. diffi cile include 2 additional tests for running QC

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3 - 20 minutes depending on test

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DCA controls; Multistix 10SG, Multistix PRO, and Clinitek Microalbumin 2 have various references depending on the analyte on the reagent strip. Details in the reagent insert. Clinitest hCG is a lateral flow, chromatographic result and is referenced to lateral flow immunoassay methods.

DCA Vantage: QC lockout, user access restrictions. Clinitek Status Connect provides QC testing and reporting, QC reminders or mandatory prompt, and QC lockout.

DCA Vantage: QC lockout, operator lockout, user access restrictions. Clinitek Status Connect allows up to 700 defined operators, operator lockout to prevent unauthorized use and customized access levels for each operator for performing patient tests, performing QC tests, recalling results, and modifying system settings.

DCA Vantage: 5 minutes. Multistix 10SG routine urine strip: 60 seconds. Multistix PRO reagent strip: 60 seconds. Clinitek Microalbumin reagent strip: 60 seconds. Clinitest hCG pregnancy test: 5 minutes or less to confi rm the result.

DCA Vantage: New software V3.0 has flexible connectivity options with POCT1-A2 communication protocoland improved ASTM connectivity. Bi-directional communication capabilities when connected toa POC data manager or common third-party data managers. Easily interfaced to RAPIDComm,Siemens proprietary POC data management solution. Clinitek communication protocol: HL7 and POCT1-A2. Data transmission options: wireless, Ethernet or serial connection. Interfaces with leading point-of-care data management solutions: Siemens RAPIDComm Data Management and Connectivity Solution, MAS RALS Plus, Telcor Quick-Linc, Sybase and Antek.

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internal and positive controls in every test

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2011 POCT BUYERS GUIDE 2011 ANNUAL POCT - Advance€¦ · ANNUAL POCT BUYERS GUIDE 2011 ......

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