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
—
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 —
AL030711_edit_CUT.indd 51AL030711_edit_CUT.indd 51 3/8/11 2:20:45 PM3/8/11 2:20:45 PM
52 MARCH 2011 • ADVANCE /LABORATORY • WWW.ADVANCEWEB.COM
COMPANY PRODUCT TYPE OF ANALYZER/ASSAY TEST MENU SAMPLE TYPE/SIZE
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™
—
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)
2011 POCT BUYERS GUIDE
AL030711_edit_CUT.indd 52AL030711_edit_CUT.indd 52 3/8/11 2:20:56 PM3/8/11 2:20:56 PM
WWW.ADVANCEWEB.COM • ADVANCE /LABORATORY • MARCH 2011 53
PRODUCT REFERENCE METHODS QC FEATURES SECURITY FEATURES TURNAROUND TIME DOWNLOADING CAPABILITIES/CONNECTIVITY OPTIONS
HIV 1/2 Clearview HIV 1/2 Rapid Test Controls sold separately. Test device includes built-in internal control. —
15 minutes read time —
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. —
15 minutes read time —
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
Onboard procedural control and positive and negative controls with kit —
30 minutes—
Clostridium difficile toxin A and toxin B rapid test
Onboard procedural control and positive and negative controls with kit —
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
AL030711_edit_CUT.indd 53AL030711_edit_CUT.indd 53 3/8/11 2:20:56 PM3/8/11 2:20:56 PM
54 MARCH 2011 • ADVANCE /LABORATORY • WWW.ADVANCEWEB.COM
COMPANY PRODUCT TYPE OF ANALYZER/ASSAY TEST MENU SAMPLE TYPE/SIZE
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
—
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
—
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.
2011 POCT BUYERS GUIDE
AL030711_edit_CUT.indd 54AL030711_edit_CUT.indd 54 3/8/11 2:21:09 PM3/8/11 2:21:09 PM
WWW.ADVANCEWEB.COM • ADVANCE /LABORATORY • MARCH 2011 55
PRODUCT REFERENCE METHODS QC FEATURES SECURITY FEATURES TURNAROUND TIME DOWNLOADING CAPABILITIES/CONNECTIVITY OPTIONS
—
Automatic QC
—
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.
—
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.
—
—
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.
—
Strep A, Ultra Strep A (50 test), Mono and C. diffi cile include 2 additional tests for running QC
—
3 - 20 minutes depending on test
—
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.
—
internal and positive controls in every test
— — —
AL030711_edit_CUT.indd 55AL030711_edit_CUT.indd 55 3/8/11 2:21:09 PM3/8/11 2:21:09 PM