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[ tech ]guidePoint-of-Care Testing Products1) What is the name of your company’spoint-of-care product or product line?www.clpmag.comAlere IncAlere IncAlere San Diego IncBWaltham, Mass(877) 441-7440www.alere.comOrlando, Fla(877) 441-7440www.alere.comSan Diego(858) 805-8378www.alere.comH(8wAlere Influenza A&B TestC. DIFF QUIK CHEK COMPLETE epoc Blood Analysis SystemT2) What does this test or control detect?Influenza A&BThe C. DIFF QUIK CHEK COMPLETEsimultaneously detects GDH and ToxinsA/B from Clostridium difficile.Nine analytes on one test card; pH, pO2,Na , K , Ca , Clu, Hct, Lac; calculatedvalues: cHCO3-, cTCO2, BE(ecf), BE(b), cSO2,and cHgbAMT3) This product is:n a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in point-ofcare equipmentq a point-of-care analyzerq an accessory or supply used by pointof-care equipmentn otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in point-ofcare equipmentn a point-of-care analyzerq an accessory or supply used by point-ofcare equipmentn othern(qcqqoqN4) Please briefly explain “other”:N/ARapid laboratory assayThe epoc System has three components: asingle-use Smartcard with nine analytes;a handheld reader, which receives theinoculated Smartcard; and a host or PDA,which displays the results.5) Where is this product used? Check asmany as apply:q at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewhereq at a community screening eventq in a physician’s office or outpatientclinicq at an inpatient’s bedsideq in an inpatient staff-access areaq in a critical care unitn elsewhereq at a community screening eventq in a physician’s office or outpatient clinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewherenncnnnn6) If you answered “elsewhere,” pleaseexplain.Emergency department, microbiology,POCMicrobiology laboratoryN/AOpr7) Intended volume use:n high volumen intermediate or variablen low volumeq high volumen intermediate or variablen low volumen high volumen intermediate or variablen low volumeqnn8) What is the throughput under idealconditions?Not limited by the test, multiple tests canbe run at one time, 10 minutes to resultsNot limited by assayThe turnaround time for tests isapproximately 3 minutes for the entireprocess. Once the patient’s sample isintroduced to the reader, the test time is lessthan 30 seconds.5c9) What is the typical training time?1 to 2 hours1 to 2 hoursTest time is approximately 30 seconds oncethe sample is introduced.1 11 to 14The list price for the epoc System (readerand host) is 7,900. The list price for asingle blood gas, electrolyte, and metaboliteSmartcard is 16. Depending upon volumeand GPO affiliation, these prices arediscounted. There are various programssuch as “reagent rentals” to acquire thesystem.BroThe C. DIFF QUIK CHEK COMPLETE is theonly test on the market that simultaneouslydetects and differentiates GDH and ToxinsA/B from C. difficile in a rapid cassette.The epoc Smartcard incorporates a singleuse, self-calibrated test every time with afull menu on the card. It can be stored atroom temperature with no refrigeration.The bar coding, with lot and expirationdate, are actually on the Smartcard and notpackaging, which can minimize errors. A92-microliter blood sample is required afterthe Smartcard has been calibrated, reducingthe concerns relative to blood sample waste.TtodAo510) What is the typical price range?11) What differentiates this product fromothers on the market?20 14 to 16 per testHighly accurate, simple procedure in a10-minute turnaround time.July 2012 clpmag.comCLP07 p20-27 Techguide QA.indd 206/29/12 8:49:40 AM

SO2,of--of-:as;A,inics lessonceBio-Rad LaboratoriesDiazyme LaboratoriesGlobe Scientific IncGlobe Scientific IncHercules, Calif(800) 224-6723www.bio-rad.comPoway, Calif(858) 455-4768www.diazyme.comParamus, NJ(201) 599-1400www.globescientific.comParamus, NJ(201) 599-1400www.globescientific.comTOX/See Rapid Urine Drug Screen TestSMART Cystatin C Point of Care SystemMicro-hematocrit Capillary TubesPocket BalanceAMP, BAR, BUP, BZO, COC, MDMA, MET,MTD, OPI300, OPI2000, OXY, PCO, PPX,TCA, THCWhole Blood Cystatin C for early detectionof acute or chronic kidney diseaseHematocrit in humans and animalsThis portable instrument is a scale andprovides the weight of a sample.n a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in point-ofcare equipmentq a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in point-ofcare equipmentn a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq othern a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq othern a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq otherN/AN/AN/AN/An at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewheren at a community screening eventn in a physician’s office or outpatientclinicq at an inpatient’s bedsiden in an inpatient staff-access areaq in a critical care unitn elsewheren at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitn elsewheren at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitn elsewhereOccupational health, juvenile facilities,police departments, correctional facilities,recovery and rehabilitation programs.Interventional Radiology for determinationof eGFR, determination of kidney functionprior to treatmentField, makeshift labs, WHO testingcenters in AfricaField, makeshift labs, WHO testingcenters in Africaq high volumen intermediate or variablen low volumeq high volumen intermediate or variableq low volumen high volumeq intermediate or variableq low volumen high volumeq intermediate or variableq low volume5 minutes to run one test, manual test, socan set up multiple tests at one time.Nine tests per hourUnlimitedUnlimited1 hourLess than 1 hour1 minute5 minutes. Simply read the providedinstructions.Based on customer volume, list priceranges from 91 up to 1,571, dependingon the number of tests in the cartridge.Contact company 0.032/test 175This is the first POC testing system thatuses Cystatin C as an early marker foracute and chronic kidney disease.Both glass and plastic options areavailable. Both plain and heparinizedcapillary tubes are available. We alsooffer precalibrated pipettes, pipettebulbs, and a 24-place specimen holder.A separate micro-hematocrit centrifugeis also available.Available with a scale up to 200g andcan measure in g, oz, and qty, has anLCD display, is battery operated andfits in your pocket.erolitemeleaatnotAafterucingaste.TOX/See is a one-step, point-of-caretest device for the qualitative detectionof up to 14 drugs in urine. Twenty-ninedifferent test combinations are available.All products are FDA cleared and feature aone-step test protocol with results in5 minutes and stable for 1 hour.clpmag.com July 2012CLP07 p20-27 Techguide QA.indd 21216/29/12 8:49:40 AM

[ tech ]guidewww.clpmag.comGlobe Scientific IncHelena LaboratoriesHelena LaboratoriesInstrumentation LaboratoryParamus, NJ(201) 599-1400www.globescientific.comBeaumont, Tex(800) 231-5663www.helenapoc.comBeaumont, Tex(800) 231-5663www.helenapoc.comBedford, Mass(800) 955-9525www.ilus.comPrecision ThermometersCascade POCPlateletWorksGEM Premier 4000TemperatureProthrombin Time and INR(PT-C, PT-WB), activated PartialThromboplastin Time (aPTT), ActivatedClotting Time (c-ACT)Platelet functionThe GEM Premier 4000 measures pH,pCO2, pO2, Na , K , Ca , Cl-, Glu, Lac,Hct, tHb, O2Hb, COHb, MetHb and HHb,tBili. In development: BUN, Creat, tCO2n a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)n a single-patient test for use in pointof-care equipmentn a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentn otherq a self-contained point-of-care test(requiring no equipment)n a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentn otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in point-ofcare equipmentn a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherN/AThe Cascade POC is a point-of-carecoagulation analyzer and reagentsystem that performs one-stageprothrombin times, one-stage activatedpartial thromboplastin times, andactivated clotting times.PlateletWorks can be used with anyimpedance hematology analyzer.PlateletWorks offers three differentagonist tubes, collagen, ADP, andArachidonic Acid.N/An at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitn elsewhereq at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewhereq at a community screening eventn in a physician’s office or outpatientclinicq at an inpatient’s bedsiden in an inpatient staff-access areaq in a critical care unitn elsewhereq at a community screening eventq in a physician’s office or outpatientclinicq at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitn elsewhereField, makeshift labs, WHO testingcenters in AfricaEmergency departments, surgical suites,clinical laboratoryClinical laboratory, surgical suiteOR, ICU, NICU, ER as well as RTDepartments and Central Laboratoryn high volumeq intermediate or variableq low volumeq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volumeUnlimitedPT/aPTT: 24 per hour; ACT: 10 per hour30 test/hour20 samples/hourReading instructions.Less than 1 hourLess than 1 hourMinutes 5Cascade POC Coagulation Analyzer 3,500, PT, aPTT, and c-ACT Cards 3.50 11 to 15 per testContact companyResults less than 10 minutes, low cost,platelet count includedThe GEM Premier 4000 is the onlyanalyzer that offers a comprehensive,fully integrated and easy-to-use system,providing lab-quality results 24/7,regardless of system location or level ofoperator training, with complete remotemanagement. The single-component,multiuse GEM Premier 4000 cartridgeincludes all analytic componentsneeded for testing. Multiple cartridgeconfigurations.A wide range of mercury glassthermometers, yellow backed,prismatic capillary filled with inert gasand calibration certificate.22Broad test platform, small sample size,low cost, suitable for both POC andclinical laboratory, ease of useOJuly 2012 clpmag.comCLP07 p20-27 Techguide QA.indd 22I6/29/12 8:49:43 AM

[ tech ]guidewww.clpmag.comIris Sample ProcessingOraSure TechnologiesOraSure TechnologiesOraSure TechnologiesWestwood, Mass(781) 619-1615www.statspin.comBethlehem, Pa(800) 672-7873www.orasure.comBethlehem, Pa(800) 672-7873www.orasure.comBethlehem, Pa(800) 672-7873www.orasure.comStatSpin CritSpinOraQuick ADVANCE HCV RapidAntibody TestOraQuick ADVANCE Rapid HIV-1/2Antibody TestOraSure QuickFlu The StatSpin CritSpin is a compact,quiet, microhematocrit system thatprovides complete cell packing in only2 minutes.HCV antibodiesAntibodies to both HIV-1 and HIV-2Qualitative detection and differentiationof influenza Type A and Type B.q a self-contained point-of-care test(requiring no equipment)n a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq othern a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq othern a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq othern a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherN/AN/AN/AN/An at a community screening eventn in a physician’s office or outpatientclinicq at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitq elsewheren at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewheren at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewhereq at a community screening eventq in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewhereN/AN/AN/AN/Aq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volume12 samples in 2 minutes.Turnaround time is 20 minutes for therapid test and the tests can be batchedto streamline throughput.Turnaround time is 20 minutes forthe rapid test, and the tests can bebatched to streamline throughput.The test specimen is collected with anasal swab, nasopharyngeal swab, ornasal aspirate/wash, and results areavailable in as little as 10 minutes.None, instrument is “plug and play”There are no required individualcredentials to run this rather simpletest, which is CLIA-waived. Theestablishment/facility must have a CLIAwaiver.There are no required individualcredentials to run this rather simpletest, which is CLIA-waived. Theestablishment/facility must have aCLIA waiver, and training is relativelystraightforward.Training for this simple three-stepprocedure is easily taught and operatorperformance validated with controlswabs.Suggested list price is 1,434The list price for the test kit is 20.However, discounts are provided basedon quantityThe test kit lists for 17.50 per test.However, discounts are providedbased on quantity.The list price for the test kit is 25.However, discounts are provided basedon quantity purchased.The OraQuick ADVANCE Rapid HIV1/2 Antibody Test is the only FDAapproved rapid, HIV test that can beused with both oral fluid and/or blood.The test is CLIA-waived and providesresults in just 20 minutes. It is thenation’s leading rapid point-of-careHIV test used by hospitals, publichealth organizations, and physiciansthroughout the country.OraSure QuickFlu provides provenclinical performance with 90%sensitivity and specificity versus virusculture/PCR in all sample types anddetected the pandemic 2009 H1N1 in71.6% of CDC RT-PCR test positivespecimens. OraSure QuickFlu offersmaximum flexibility and minimal impacton workflow with no need to usetransport media. Ready-to-use, roomtemperature-stored reagents allow youto quickly begin testing. Testing canbe delayed after specimen collectionby up to 4 hours at room temperature,and longer if refrigerated, without theadditional cost of transport media.StatSpin brand name recognition,quality, small size, extremely quietoperation, portability.24The OraQuick ADVANCE HCV RapidAntibody Test is the only FDA-approvedrapid, point-of-care test for thedetection of antibodies to the hepatitisC virus. It can be used with a fingerstickblood or venous whole blood sample.The test, which utilizes the OraQuickADVANCE technology platform, providesresults in 20 minutes.July 2012 clpmag.comCLP07 p20-27 Techguide QA.indd 246/29/12 8:49:44 AM

Quantimetrix CorpQuantimetrix CorpQuidel CorpRedondo Beach, Calif(310) 536-0006www.quantimetrix.comRedondo Beach, Calif(310) 536-0006www.quantimetrix.comSan Diego(800) 874-1517quidel.comDropper A1c Diabetes ControlDropper PlusSofia (Analyzer and InfluenzaA B FIA)HbA1cControl for all urine dipstickanalytes, hCG, and microalbuminInfluenza type A and Influenzatype Bq a self-contained point-of-caretest (requiring no equipment)q a single-patient test for use inpoint-of-care equipmentq a point-of-care analyzern an accessory or supply used bypoint-of-care equipmentq otherq a self-contained point-of-caretest (requiring no equipment)q a single-patient test for use inpoint-of-care equipmentq a point-of-care analyzern an accessory or supply used bypoint-of-care equipmentq otherq a self-contained point-of-caretest (requiring no equipment)n a single-patient test for use inpoint-of-care equipmentn a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq otherN/AN/AN/An at a community screening eventn in a physician’s office oroutpatient clinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewhereq at a community screening eventn in a physician’s office oroutpatient clinicn at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitq elsewhereq at a community screening eventn in a physician’s office oroutpatient clinicq at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewhereN/AReference laboratory, retail clinicBlood banks, plasma centersq high volumen intermediate or variableq low volumeq high volumen intermediate or variableq low volumen high volumen intermediate or variablen low volumeN/AN/AReference laboratory, retail clinicMinimalWhile using in the Read Now(Batch) mode, expected throughputis approximately 40 to 50 tests/hour.Contact companyPricing varies depending uponannual test volume, length ofagreement signed, and othervariables. List price for theanalyzer is 4,500, and list pricefor the test is 22.Simple to use; packaged in plasticdropper bottles; 30 days of roomtemperature stability.Fluorescent chemistry enhancesassay sensitivity; analyzer opticallyscans and interprets results,eliminating the interpretationsubjectivity and variability fromoperator to operator; Walkawayautomation; “Read now” modefor large batches; bar codereading of patient and operatoridentity; results storage and LISconnectivity; hard copy printout;supervisory control and builtinsafeguards; compatibility withmost major VTMs.MinimalContact companySix months of refrigerated openvial stability. Twenty-one daysof open-vial room-temperaturestability. Plastic dropper bottlemakes dispensing simple.Ask your questionsabout QC and PT.Clinical Lab ProductsacknowledgesRandox for it’sgenerous sponsorhipof the QC and PTexpert.Allison CanningTrainer (Quality Mgmt Solutions Group)Looking for expert advice?www.clpmag.comSCAN ME!Scan the QR code abovewith your smartphone toconnect to ourOnline Buyer’s Guide.clpmag.com July 2012CLP07 p20-27 Techguide QA.indd 25256/29/12 8:49:44 AM

[ tech ]guidewww.clpmag.comSeparation Technology,Part of Thermo Fisher ScientificSiemens HealthcareDiagnostics IncSiemens HealthcareDiagnostics IncSiemens HealthcareDiagnostics IncSanford, Fla(407) 788-8791www.separationtechnology.comTarrytown, NY(914) 631-8000www.usa.siemens.com/diagnosticsTarrytown, NY(914) 631-8000www.usa.siemens.com/diagnosticsTarrytown, NY(914) 631-8000www.usa.siemens.com/diagnosticsRAPIDPoint and RAPIDLab Systems;Stratus CS Acute Care DiagnosticSystemCLINITEK Status Analyzer; CLINITEKStatus Connect SystemDCA Vantage AnalyzerhematocritRAPIDLab and RAPIDPoint systemsare blood gas analyzers; the StratusCS system is a point-of-care cardiacbiomarker analzyerRoutine urinalysis tests: Glucose,ketone, specific gravity, blood,leukocytes, protein, pH, bilirubin,urobilinogen, nitrite; protein-tocreatinine ratio tests; albumin-tocreatinine ratio tests; urine hCG; alltests CLIA-waivedHemoglobin A1c and Microalbuminn a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentq a point-of-care analyzerq an accessory or supply used bypoint-of-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentn a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentn a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherq a self-contained point-of-care test(requiring no equipment)q a single-patient test for use in pointof-care equipmentn a point-of-care analyzerq an accessory or supply used by pointof-care equipmentq otherN/AN/AN/AN/An at a community screening eventn in a physician’s office or outpatientclinicn at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewhereq at a community screening eventq in a physician’s office or outpatientclinicq at an inpatient’s bedsideq in an inpatient staff-access arean in a critical care unitn elsewheren at a community screening eventn in a physician’s office or outpatientclinicq at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitq elsewheren at a community screening eventn in a physician’s office or outpatientclinicq at an inpatient’s bedsiden in an inpatient staff-access arean in a critical care unitn elsewhereBlood banks, plasma centersThese analyzers are used within hospitals:EDs, Respiratory, LabsN/AEmergency department, diabetic clinicsq high volumen intermediate or variableq low volumen high volumen intermediate or variablen low volumeq high volumen intermediate or variablen low volumeq high volumen intermediate or variablen low volume80 seconds for first sample,10 seconds each for next five testsBlood Gas RAPIDPoint is cartridge-based,and each cartridge has a specific amountof tests available 250, 400, 750 testsUrine strip tests 1 minute; Urine hCG 2-5 minutes6 minutes per test, 10 per hour peranalyzer10 minutes2 hours15 minutes30 to 45 minutes 2,000N/ACLINITEK Status Analyzer 899;CLINITEK Status Connect System 1,999See your local distributor.The Stratus CS system is a whole blooduni dose analyzer that provides results in14 minutes without preanalytical samplehandling with a high sensitive troponinthat helps hospitals meet the new CMSOP 16 regulation. RAPIDPoint BloodGas systems are comprehensive criticalcare solutions using trusted and reliabletechnology to streamline monitoring andanalysis of blood gas results.Improve quality control via instrumentQC reminders, QC lock-out, and datamanagement. Increase efficiencythrough flexible connectivity options toEMR, DMS, and LIS. Maintain reagentintegrity and result accuracy with AutoChecks feature for humidity checks andauto-strip detection. Expand clinicalutility through a diversified Point-of-Caretest portfolio. Improve data security withprogrammable operator managementand lock-out. Market leader in POCurinalysis including reagents andinstruments.Accurate results, flexible connectivityto EMR or LIS, trend chart for patienttest results, GFR calculation, standardkeyboard, touchscreen display, onboardprinter, and smallest blood sample—1 µL.HemataSTAT II MicrohematocritSystemVery low cost per test, uses standardhematocrit tubes; built-in digitaltube reader; LCD display of results;small, lightweight; quiet; optionalrechargeable battery26July 2012 clpmag.comSPIA Ad CCLP07 p20-27 Techguide QA.indd 266/29/12 8:49:46 AM

20 July 2012 clpmag.com Alere Inc Alere Inc Alere San Diego Inc Bio-Rad Laboratories Diazy

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