Same, Fewer, Small, And Single—companies In
12 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringSame, fewer, small, andsingle—companies instep with latest needsProfiled on pages 12–22 are 16 point-ofcare and self-monitoring coagulation testsystems from eight companies. Top of mindare standardization and the sophisticatedcustomers who need smarter instruments.“As we move into a health care systemdriven by more integrated health networksand accountable care organizations, we willsee customers wanting to standardize acrossa test platform to gain economies of scale,”says Jill Downey, Roche Diagnostics’ CoaguChek product marketing manager, professional diagnostics—physician office lab.Roche designed its CoaguChek XS, XS Pro,and XS Plus coagulation meters to use thesame test strips. The CoaguChek XS Plusmeter received a CLIA waiver in September2012, Downey says, and customers now areable to use the same meter system in multiple locations within their integrated healthcare network. With the focus on ACO qualitymeasures, she says, customers will want tostandardize across different test parameters—blood glucose and blood gas, for example—and they’ll want connectivity thatmakes it possible to manage multiple platforms under a single system.Awaiting the FDA’s clearance of its Abrazo system is Helena Point of Care, whichmarkets the Actalyke XL, Actalyke Mini II,and Cascade POC test systems. Abrazo (notin the product guide) is a next-generationversion of the Cascade POC and was developed with the input of numerous focusgroups, says Helena global product managerDave Pearman. Helena is completing oraugmenting clinical trials on the CascadePOC’s more esoteric assays—direct thrombin inhibitor, low-molecular-weight heparin,low-range ACT, heparin titration, protaminetitration, and fibrinogen. The broad Abrazomenu will allow the user to reduce the number of instruments required to monitor anticoagulants and investigate pathologies,Pearman says, “with the added benefits ofergonomics, small sample size, and advanced software features and connectivity.”Of the newer anticoagulants, Pearman says,“The debate between pharma and POC diagnostic manufacturers continues on whether there’s a future” for assays that target thenewer drugs.New from ITC this year will be its ITCEnsemble software, which provides a single,common data-management and configuration platform for the company’s point-of-carecoagulation instruments and its CO-oximetryand blood gas instruments, Beth O’Connell,director of marketing, says. ITC launched itsProTime InRhythm system (not in the productguide) in select European markets.In CAP TODAY’s guide to POC and selfmonitoring coagulation systems are products from these companies and others fromAbbott Point of Care, Alere, CoaguSense,Instrumentation Laboratory, and MedtronicCardiac Surgery. Readers interested in aparticular product should confirm it has thestated features and capabilities.—Brendan DabkowskiPart 1 of 6See captodayonline.com/productguidesfor an interactive version of guideAbbott Point of CareJoe Freelsjoe.freels@apoc.abbott.com400 College Road EastPrinceton, NJ 08540609-454-9000AlereDeborah Blundell9975 Summers Ridge RoadSan Diego, CA 92121877-441-7440www.alere.comInstrument namei-STAT 1First year sold2000Alere INRatio/Alere INRatio2 PT/INR MonitoringSystem2003 (INRatio)/2008 (INRatio2)No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring analyzer?Specimen type———U.S./CanadaPOCfresh whole blood from arterial, venous, orskin puncturehandheld/portable9.25 3.03 2.85/22.56 oz17 µL–95 µLModel typeDimensions in inches (H W D)/WeightSpecimen volume needsClotting-based tests for which device hasFDA-cleared applicationsTests using other methodologies for which devicehas FDA-cleared applicationsPT/INR, ACT kaolin, ACT celite———U.S./U.S.POC and self-monitoring analyzerfingerstickhandheld/portable5.9 2.9 1.8/9.3 oz with batteriesaccurate volume not necessary (drop) 15 µLPT (reportable range: low 7 seconds, high 75seconds; INR: low 0.7, high 7.5)—FDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for clearancechemistries/electrolytes (sodium, potassium,chloride, TCO2, anion gap, ionized calcium,glucose, urea nitrogen, creatinine, lactate);hematology (hematocrit, hemoglobin); bloodgases (pH, PCO2, PO2, TCO2, HCO3, baseexcess, sO2); cardiac markers (cTnI, CK-MB,BNP)———Method of endpoint detectionelectrogenicelectrochemical detection, change inimpedance as sample clotsQuality control methods Electronicyes Liquidyes Lyophilized Integrated QC with each analysis Automatic lockout for QC failure Otheryes (plasma)yesyes—no (not required, built-in two-level QC oneach strip)no (not required, built-in two-level QC oneach strip)noyesyes—Time (in minutes) to perform control plus specimen test PT PT and PTT ACT3 —3 1—————Data-management capabilityIncludes QCSystem can automatically transfer data toinformation system Patient data QC dataInterface supplied by instrument vendoroptional add-onyesyesyesyesyesyesyesyesyesLOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotelynopackage insertSunquest, Cerner, Soft, McKesson, Meditech,GE, Siemens, VistA, othersyes——Alere CoagClinic and PC ConnectnoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar code) for: Patient specimen ReagentyesnoyesyesnonoOnboard system for automatic error detectionyesyes, for sample (volume), reagent stabilityTraining provided with instrument purchaseApproximate number of training hours needed for: Medical staff PatientPatient self-testing program is availableyes (on site)yes (on site)1 —no11yesInstrument list price— 1,595 professional; 1,995 self-testReagent rental or lease onlyCost per sample for: PT: Cost per sample for reagent rentalCost per sample if device purchased PTT: Cost per sample for reagent rentalCost per sample if device purchased ACT: Cost per sample for reagent rentalCost per sample if device purchasedCLIA ’88 complexity nt—————CLIA-waivedbroad testing menu; many data-managementand interfacing options; easy to use;integrated wireless capability for real-timetransmission to EMRo nboard QC—two levels of quantitativecontrols with reportable results; individuallywrapped, nonrefrigerated test strips; onedrop fingerstick sample; 12-month dating ontest strips; 120-test memory, including QCvalues; simple three-step test process;human recombinant thromboplastin (ISI 1.0)Distinguishing features (supplied by company)Note: a dash in lieu of an answer means company did notanswer question or question is not applicableTabulation does not represent an endorsement by the College of American Pathologists.
14 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringShareyourfavoritearticlesfrom thisissue ofCAP TODAYwith aclick ofyour mousecaptodayonline.comnow it's easyto save, searchprint, e-mail,bookmark, andlink directlyto featuredinformationin CAP TODAYPart 2 of 6See captodayonline.com/productguidesfor an interactive version of guideCoaguSenseDouglas Pattersondpatterson@coagusense.com48377 Fremont Boulevard, Suite 113Fremont, CA 94538866-903-0890 www.coagusense.comHelena Point of CareDavid Pearman dpearman@helena.com1530 Lindbergh DriveBeaumont, TX 77707800-231-5663www.helena.comInstrument nameFirst year soldCoag-Sense PT/INR Monitoring System2010Cascade POC2008No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:———400 /250 ——Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring analyzer?U.S./U.S.POC and self-monitoringU.S./U.S.POCSpecimen typefingersticknon-citrated whole blood (fingerstick orvenipuncture); citrated whole blood or plasmaModel typeDimensions in inches (H W D)/WeightSpecimen volume needshandheld/portable3 6.5 5.75/1.2 lb (with 4 AA 1.5V alkaline batteries)accurate volume required (pipetted)portable3.9 6 10.5/4.25 lbaccurate volume required (pipetted)Clotting-based tests for which device hasFDA-cleared applicationsPT (reportable range: low 7 seconds, high 180seconds; INR: low 0.8, high 8.0)PT, PT-INR, APTT, Celite ACTTests using other methodologies for which devicehas FDA-cleared applications——FDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for clearance——————Method of endpoint detectiondirect micromechanical clot detection, measuresactual time required for clottingphoto-mechanicalQuality control methods Electronic Liquid Lyophilized Integrated QC with each analysis Automatic lockout for QC failure Other—yesyesnono—yesnoyes (plasma)noyes—Time (in minutes) to perform control plus specimen test PT PT and PTT ACT 1——255–12Data-management capabilityIncludes QCSystem can automatically transfer data to information system Patient data QC dataInterface supplied by instrument vendorno—onboardyesnonoyesyesyesno, third partyLOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotelynoWeb site, package insert, e-mail queryOrchard Softwareno——nonoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar code) for: Patient specimen Reagentnononoyesyes, manualyes, manualOnboard system for automatic error detectionyes, for sample (volume), reagent stabilityyesTraining provided with instrument purchaseApproximate number of training hours needed for: Medical staff PatientPatient self-testing program is availableyes (on site)yes (on site)11yes, available through IDTF30 minutes—noInstrument list price 1,062.50 3,590Reagent rental or lease onlyCost per sample for: PT: Cost per sample for reagent rentalCost per sample if device purchased PTT: Cost per sample for reagent rentalCost per sample if device purchased ACT: Cost per sample for reagent rentalCost per sample if device purchasedCLIA ’88 complexity ratingnoyes— 5 per strip————CLIA-waivedvariable 2.50– 3.24variable 2.25– 3.50variable 2.25– 3.50nonwaivedDistinguishing features (supplied by company)directly detects clot formation; emulates WHOmultiple tests, same device; eight-hour batteryreference tilt-tube method using micromechanicaloperation; low cost per testclot detection; system not affected by low hemoglobinor hematocrit levels; %CVs of 2.5 percent; runs trueplasma controls with the actual thromboplastin andplasma of known INR; two levels of controls includedwith each box of strips; individually wrapped,nonrefrigerated, bar-coded test strips with 24-monthdating and ISI of 1.0Note: a dash in lieu of an answer means company did notanswer question or question is not applicableTabulation does not represent an endorsement by the College of American Pathologists.
16 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringPart 3 of 6See captodayonline.com/productguidesfor an interactive version of guideHelena Point of CareDavid Pearman dpearman@helena.com1530 Lindbergh DriveBeaumont, TX 77704800-231-5663www.helena.comHelena Point of CareDavid Pearman dpearman@helena.com1530 Lindbergh DriveBeaumont, TX 77704800-231-5663www.helena.comInstrumentation LaboratoryMeriel Fulton mfulton@ilww.com180 Hartwell RoadBedford, MA 01730781-861-4165www.ilus.comInstrument nameFirst year soldActalyke XL2002Actalyke Mini II2004GEM PCL Plus2003No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:200 /2,400 —— 250/ 250——Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring analyzer?300 /300 —operating room: 40; cardiac catheterization lab: 45;stat lab: 15; NICU: 15U.S./U.S.POCU.S./U.S.POCU.S./U.S.POCSpecimen typevenipuncture (whole blood)venipuncture (whole blood)Model typeDimensions in inches (H W D)/WeightSpecimen volume needsportable5.6 10.7 10.3/15 lbaccurate volume required (fill line on cuvette)portable6.25 6 5/6.3 lbaccurate volume required (fill line on cuvette)fresh whole blood, citrated whole blood(fingerstick for PT only)handheld/portable2.0 7.5 3.5/0.75 lbaccurate volume not necessary ( 50 µL), low samplevolume error message if well not filledClotting-based tests for which device hasFDA-cleared applicationsactivated clotting time (ACT)–whole blood, MAX-ACT:maximum factor XII activation ACT, celite, kaolin,glassACT—MAX-ACT, C-ACT, K-ACT, G-ACTTests using other methodologies for which devicehas FDA-cleared applicationsFDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for clearance——PT and citrate PT (reportable range: 10–150 seconds;INR: 0.8–12 seconds), APTT (reportable range:20–300 seconds), ACT (reportable range: 65–1,005seconds), ACT–low range (reportable range: od of endpoint detectiontwo-point electromechanical soft-clot detectionprincipletwo-point electromechanicalmechanical endpoint clotting mechanism,monitored opticallyyesyesyesnoyesdata management for entering heparin dose,L-J chart generation for all controlsyesyesyesnono—yesyes (simulated whole nt capabilityIncludes QCSystem can automatically transfer data to information system Patient data QC dataInterface supplied by instrument vendoryesyesnonoonboard (via GEM Premier 3000/3500)yesyesyesinterface specifications supplied, POCT1-A compliant———yesyes—LOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotelyno——no——no——nononoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar code) for: Patient specimen Reagentyes—noyesyes; all disposables have bar code for identificationwith use on any Actalyke modelyes, stuck magnet, no tube; mechanical instrumentparameters only; well rotation, temperature, anddetection settingsnononoyesyes, for stuck magnet, printer problemsyes, for sample (volume), reagent, and instrumentTraining provided with instrument purchaseApproximate number of training hours needed for: Medical staff PatientPatient self-testing program is availableyes (on site)yes (on site)yes (on site)1–2—no1—no30 minutes—noInstrument list price 3,805 5,329 (volume-dependent)Reagent rental or lease onlyCost per sample for: PT: Cost per sample for reagent rentalCost per sample if device purchased PTT: Cost per sample for reagent rentalCost per sample if device purchased ACT: Cost per sample for reagent rentalCost per sample if device purchasedCLIA ’88 complexity ratingpurchase, lease, or reagent rental 1,024 (battery only)– 1,334 (with printer andbattery)purchase, lease, or reagent rental————— 0.74– 1.76moderate————— 0.74– ependentnonwaivedDistinguishing features (supplied by company)t wo-point electromechanical soft-clot detectionprinciple; MAX-ACT: maximum factor XII activationACT test, 0.5-mL blood volume, linear up to 10 unitsof heparin, safer plastic tube construction, for useon Actalyke and Hemochron instruments; electronicclotting tube (ECT) that simulates and mimics actualblood clot formation for accurate ECT challenges;integrated printer; 3.5-inch diskette storagetwo-point electromechanical soft-clot detection;magnetic detection device—electronic QC/revolution; MAX-ACT tubes, 0.5-mL volume and linearto 6 U/mL; linear up to 6 U/mL of heparin; electronicclotting tube availableused in conjunction with the GEM Premier 3000/3500analyzer; independently interfaces with HIS/LIS;consolidates blood ation testing; comprehensivePOC coagulation menu allows for POC coagulationanalysis throughout an institution; whole-bloodPT, citrate PT, APTT, ACT, and ACT-low range;patient safety features: automatic QC lockout,mandatory operator and patient ID options, databasemanagement (patient history query), fully automatedsample measuring and mixing, inaccurate samplevolume detection and optical monitoringQuality control methods Electronic Liquid Lyophilized Integrated QC with each analysis Automatic lockout for QC failure OtherTime (in minutes) to perform control plus specimen test PT PT and PTT ACTOnboard system for automatic error detectionNote: a dash in lieu of an answer means company did notanswer question or question is not applicableTabulation does not represent an endorsement by the College of American Pathologists.outright purchase, lease, reagent rental
18 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringPart 4 of 6See captodayonline.com/productguidesfor an interactive version of guideITCcustomerservice@itcmed.com8 Olsen AvenueEdison, NJ itcmed.com8 Olsen AvenueEdison, NJ itcmed.com8 Olsen AvenueEdison, NJ 08820732-548-5700www.itcmed.comInstrument nameFirst year soldProTime Microcoagulation SystemProTime Micro: 1995; ProTime: 2006Hemochron Signature Elite2005Hemochron Signature 2002No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring C———U.S./U.S.POCSpecimen typefingerstickModel typeDimensions in inches (H W D)/WeightSpecimen volume needshandheld/portable2.7 4.5 8.5/3 lbsmall blood sample volume needed, 25 µLvenipuncture, fingerstick, fresh whole blood,citrated bloodhandheld/portable2 7.5 3.7/1.2 lbone drop (low sample volume error messageprovided if well not filled)venipuncture, fingerstick, fresh whole blood,citrated bloodhandheld/portable2 7.5 3.75/12 ozone drop (low sample volume error messageprovided if well not filled)Clotting-based tests for which device hasFDA-cleared applicationsPT (reportable range: low 10 seconds, high 130seconds; INR: low 0.8, high 9.9)PT, APTT, PT citrate, APTT citrate, ACT , ACT-LRPT, APTT, PT citrate, APTT citrate, ACT , ACT-LRTests using other methodologies for which devicehas FDA-cleared applicationsFDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for d of endpoint detectionmechanical clot detectionmechanical clot detectionmechanical clot detectionyes, internal automatic EQCyes (simulated whole blood)yesyes (simulated whole blood) Lyophilized Integrated QC with each analysis Automatic lockout for QC failure Otherno (not required, onboard QC)yes (available as an option but not required due toonboard controls)noyesyestwo levels of onboard QC integrated into each cuvetteyes (simulated whole blood)noyesoperator lockout, certification lockout, audit trail,and patient identification lockoutyes (simulated whole blood)noyesoperator lockoutTime (in minutes) to perform control plus specimen test PT PT and PTT ACT 5——221–5221–5Data-management capabilityIncludes QCSystem can automatically transfer data to information system Patient data QC dataInterface supplied by instrument vendorLOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotelyyesyes (onboard yes———yes, Telcor QML, Alere RALS-Plus and Aegis POCyesyes———yes, Telcor QML, Alere RALS-Plus and Aegis POCnononoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar code) for: Patient specimen Reagentnoyes, via connectivity partnersnonoyesnoyesnoyesOnboard system for automatic error detectionyes, for sample (volume) and reagent-cuvetteexpiration dateyes, for sample (volume) and reagent-expiration dateyes, for sample (volume)Training provided with instrument purchaseApproximate number of training hours needed for: Medical staff PatientPatient self-testing program is availableyes (on site)yes (on site)yes (on site)11.5yes (training CD/Web-based training)1—————Instrument list price 1,749 professional; 2,350 consumer 7,900 5,385.60Reagent rental or lease onlyCost per sample for: PT: Cost per sample for reagent rentalCost per sample if device purchased PTT: Cost per sample for reagent rentalCost per sample if device purchased ACT: Cost per sample for reagent rentalCost per sample if device purchasedCLIA ’88 complexity ratingyespurchase and rental availablepurchase and rental teDistinguishing features (supplied by company)t wo levels of reagent control automatically run witheach patient; internal instrument checks verifyoptical, electrical, and mechanical functions—nofurther calibration required; sensitive thromboplastinreagent (ISI 1.0), as recommended by AHA, CAP,and WHO; results in less than five minutes; 16-hourroom-temperature open-pouch stability of cuvette;bar-coded cuvette—no coding neccessary; acceptsand stores patient/operator ID; automatically sendstest results to printer, computer, LIS; onboard andexternal controlscomprehensive microcoagulation test menu allowsfor standardization; integrated bar-code scanner;compliance technology; QC, PID, and OID; lockoutand tracking; data-management storage andprinting; optimal connectivity options; 15-µL bloodvolume; Ethernet and RS232 ports; standardizesanticoagulation therapy monitoring across continuumof care, while enhancing compliance and patientsafety and maximizing efficiencies15 µL blood volume; ease of use; data-managementstorage and printing; connectivity options;configurable QC and operator lockout; standardizesanticoagulation therapy monitoring acrosscontinuum of careQuality control methods Electronic LiquidNote: a dash in lieu of an answer means company did notanswer question or question is not applicableTabulation does not represent an endorsement by the College of American Pathologists.
20 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringPart 5 of 6See captodayonline.com/productguidesfor an interactive version of guideITCcustomerservice@itcmed.com8 Olsen AvenueEdison, NJ 08820732-548-5700www.itcmed.comMedtronic Cardiac Surgery7611 Northland Drive NorthMinneapolis, MN 55428800-328-3320www.medtronic.comMedtronic Cardiac Surgery7611 Northland Drive NorthMinneapolis, MN 55428800-328-3320www.medtronic.comInstrument nameFirst year soldHemochron Response2000HMS Plus1999ACT Plus2003No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:—————————Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring men typevenipuncture, fresh whole blood, citrated bloodvenipuncture (whole blood)venipuncture (whole blood)Model typeDimensions in inches (H W D)/WeightSpecimen volume needshandheld/portable8.7 10.5 7.5/6.4 lbaccurate volume required (fill line on tubes)benchtop15.7 15 13/34 lbaccurate volume required (automated dispensing)benchtop11 8 13/11.5 lbaccurate volume required (fill line on cuvette andoptional easy fill accessory)Clotting-based tests for which device hasFDA-cleared applicationsACT (HRFTCA510, HRFTK-ACT, P214), HRT, KHRT, PRT,KPRT, PDAO, PDAOKACT, heparin dose response, heparin protaminetitrationACT (high range, low range, recalcified, high-rangeheparinase)Tests using other methodologies for which devicehas FDA-cleared applicationsFDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for d of endpoint detectionmechanical clot detectionmechanical clot detectionmechanical clot detectionQuality control methods Electronic Liquid Lyophilized Integrated QC with each analysis Automatic lockout for QC failure Otheryesyes (simulated whole blood)yes (simulated whole blood)noyesoperator lockoutyesnoyesnooptional (user defined)optional operator lockoutyesnoyesnooptional (user defined)optional operator lockoutTime (in minutes) to perform control plus specimen test PT PT and PTT ACT221–5——up to 12 (depending on patient sample)——up to 12 (depends on patient sample)Data-management capabilityIncludes QCSystem can automatically transfer data to information system Patient data QC dataInterface supplied by instrument noLOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotely——Telcor QML, Alere RALS-Plus, and Aegis POC—Web siteTelcor, Alere Informatics—Web siteTelcor, Alere InformaticsnononoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar code) for: Patient specimen ReagentnonononoyesyesyesyesyesOnboard system for automatic error detectionyes, for sample (volume) and reagent-expiration dateyesyesTraining provided with instrument purchaseApproximate number of training hours needed for: Medical staff PatientPatient self-testing program is availableyes (on site)yes (on site)yes (on site)1–2——6—no1—noInstrument list price 4,851 29,000 4,200Reagent rental or lease onlyCost per sample for: PT: Cost per sample for reagent rentalCost per sample if device purchased PTT: Cost per sample for reagent rentalCost per sample if device purchased ACT: Cost per sample for reagent rentalCost per sample if device purchasedCLIA ’88 complexity ratingpurchase and rental availablerental and purchase availablerental and purchase �————customer-dependent, per contractmoderate (nonwaived)—————customer-dependent, per contractmoderate (nonwaived)Distinguishing features (supplied by company)QC lockout; data-management storage; connectivityoptions; RxDx heparin/protamine dosing systemautomated sample dispensing; constant temperaturecontrol; multiple testing capability; heparin doseresponse; heparin protamine titration; high-rangeACT; optional bar-code scanner; data-managementsoftware; HMS Plus education program CDdata-management software application; duplicatetest results; optional bar-code scanner; optional easyfilling accessory; ACT Plus education program CDNote: a dash in lieu of an answer means company did notanswer question or question is not applicableTabulation does not represent an endorsement by the College of American Pathologists.
22 / CAP TODAYMay 2013Coagulation analyzers—point of care, self-monitoringPart 6 of 6See captodayonline.com/productguidesfor an interactive version of guideRoche DiagnosticsJill Downey jill.downey@roche.com9115 Hague RoadIndianapolis, IN 46250317-521-1829 or 317-902-6014www.poc.roche.comRoche DiagnosticsJill Downey jill.downey@roche.com9115 Hague RoadIndianapolis, IN 46250317-521-1829 or 317-902-6014www.poc.roche.comRoche DiagnosticsJill Downey jill.downey@roche.com9115 Hague RoadIndianapolis, IN 46250317-521-1829 or 317-902-6014www.poc.roche.comInstrument nameCoaguChek XS PT Test SystemCoaguChek XS Plus PT Test SystemCoaguChek XS Pro PT Test SystemFirst year sold2006 (international)/2007 (U.S.)20072010No. of units sold in U.S./Outside U.S.No. of units sold in 2012 units sold to:—/————/————/———Country where analyzer designed/ManufacturedIs instrument POC or self-monitoring analyzer?Germany/GermanyPOC and CSpecimen typefresh whole blood (venous or fingerstick capillary)fresh whole blood (venous or fingerstick capillary)fresh whole blood (venous or fingerstick capillary)Model typeDimensions in inches (H W D)/WeightSpecimen volume needshandheld/portable5.43 3.07 1.10/4.48 oz8 µLhandheld/portable7.28 3.89 1.65/350 g8 µLhandheld/portable9.09 3.89 1.65/350 g8 µLClotting-based tests for which device hasFDA-cleared applicationsPT (reportable range: low 9.6 seconds, high96 seconds; INR: low 0.8, high 8.0)PT (reportable range: low 9.6 seconds, high96 seconds; INR: low 0.8, high 8.0)PT (reportable range: low 9.6 seconds, high96 seconds; INR: low 0.8, high 8.0)Tests using other methodologies for which devicehas FDA-cleared applicationsFDA-cleared tests but not yet clinically releasedTests submitted for 510(k) clearanceTests in development but not yet submitted for d of endpoint detectionamperometric detectionamperometric detectionamperometric detectionQuality control methods Electronic Liquidno (not required, onboard QC)no Lyophilized Integrated QC with each analysis Automatic lockout for QC failure Othernoyesno—no (not required, onboard QC)yes (available as an option but not required due toonboard controls)noyesyesoptional operator lockoutno (not required, onboard QC)yes (available as an option but not required due toonboard controls)noyesyesoptional operator lockoutTime (in minutes) to perform control plus specimen test PT PT and PTT ACT 1—— 1—— 1——Data-management capabilityIncludes QCSystem can automatically transfer data to information system Patient data QC dataInterface supplied by instrument vendorLOINC codes transmitted with resultsHow labs get LOINC codes for reagent kitCommercially available systems for which interfaces areup and running in active user sitesLab can control analyzer remotelynonoyesyesyesyesnonowith CT1-Ano—RALS-PlusnononoReal-time wireless linkage to LIS or HISPositive identification system (e.g., bar
says Jill Downey, Roche Diagnostics’ Coagu-Chek product marketing manager, profes-sional diagnostics—physician office lab. Roche designed its CoaguChek XS, XS Pro, and XS Plus coagulation meters to use the same test strips. The CoaguChek XS Plus meter received a CLIA wai
SCE170A-1A 33 x 241 4 x24 115/60/1 "Half-Dice" Cube Air 10 see page 18 SCE170A-1C SAME SAME SAME Air 10 see page 18 SCE170W-1A SAME SAME SAME Water 10 see page 18 SCE170W-1C SAME SAME SAME Water 10 see page 18 . Scotsman Ice Systems are designed and manufactured with the highest regard for safety
SCE170A-1A 33 x 241 4 x24 115/60/1 "Half-Dice" Cube Air 10 see page 18 SCE170A-1C SAME SAME SAME Air 10 see page 18 SCE170W-1A SAME SAME SAME Water 10 see page 18 SCE170W-1C SAME SAME SAME Water 10 see page 18 . Scotsman Ice Systems are designed and manufactured with the highest regard for safety
SCE170A-1A 33 x 241 4 x24 115/60/1 "Half-Dice" Cube Air 10 see page 18 SCE170A-1C SAME SAME SAME Air 10 see page 18 SCE170W-1A SAME SAME SAME Water 10 see page 18 SCE170W-1C SAME SAME SAME Water 10 see page 18 . Scotsman Ice Systems are designed and manufactured with the highest regard for safety
business size by either the company's dollar value or the number of employees. The Small Business Act defines small business as generally one with fewer than 500 employees. The SBA further recognizes microbusiness as an organization with fewer than five employees and small enough to require little capital ( 35,000 or less) to get started.
the economic and investment world's most prominent forecasters. Indeed, Larry dares to optimistically charac-terize the world we're leaving to our children and grandchildren as "fewer, richer, greener." I was lucky enough to catch up with Larry the other day and got him to explain. Listen in. KMW Let's talk about "Fewer, Richer .
Grammar Warm-Ups Quarters 1,2, and 3. G 3.01 - Less vs. Fewer “Fewer” emphasizes number and is used to describe things that can be counted I have fewer assignments missing than anyone in my class. “Less” focuses on matters of degree, most often in an abstract whole.
the minimum legal sale age for tobacco products to 19, 21 and 25 years. It found that raising the tobacco MLSA to 21 would result in a 12% decrease in tobacco use, approximately 223,000 fewer premature deaths, 50,000 fewer deaths from lung cancer, and 4.2 million fewer years of life
NFPA 13-2010, 6.2.9.5 The stock of spare sprinklers shall include all types and ratings installed and shall be as follows: Under 300 no fewer than 6 300 to 1000 no fewer than 12 Over 1000 no fewer than 24 6.2.9.6 One wrench as specified by the sprinkler manufacturer must
