28 / Coagulation analyzers—point of care, self-monitoring

1 28 / CAP TODAY May 2011 Coagulation analyzers point of care, self-monitoringPart 1 of 6 Abbott Point of CareAbbott Point of CareAlereKevin Ball Douglas W. Gavin Dennis Summers Ridge Road400 College Road East400 College Road EastSan Diego, CA 92121 Princeton, NJ 08540 Princeton, NJ 08540877-441-7440 See accompanying article on page namei-STAT 1 CoaguSense PT/INR monitoring SystemINRatio/INRatio2 PT INR MonitorFirst year sold200020102003 (INRatio)/2008 (INRatio2)No. of units sold in No. of units sold in 2010 units sold to: Country where analyzer instrument POC or self- monitoring analyzer?POCPOC and self-monitoringPOC and self- monitoring analyzerSpecimen typefresh whole blood from arterial, venous, or skin puncturefingerstick, venipuncture (whole blood, plasma)fingerstickModel typehandheld/portablehandheld/portableha ndheld/portableDimensions in inches (H W D) oz3 lb (with 4 AA alkaline batteries) oz with batteriesSpecimen volume needs20 L 40 Laccurate volume required ~10 L (transfer tube or minipipette)accurate volume not necessary (drop)

2 ~15 LClotting-based tests for which device has FDA-cleared applicationsPT/INR, ACT kaolin, ACT celitePT (reportable range: low 7 seconds, high 180 seconds; INR: low seconds, high seconds)PT (reportable range: low 7 seconds, high 75 seconds; INR: low seconds, high seconds)Tests using other methodologies for which device has FDA-cleared applicationschemistries/electrolytes (sodium, potassium, chloride, TCO2, anion gap, ionized calcium, glucose, urea nitrogen, creatinine, lactate); hematology (hematocrit, hemoglobin); blood gases (pH, PCO2, PO2, TCO2, HCO3, base excess, sO2); cardiac markers (cTnI, CK-MB, BNP) FDA-cleared tests but not yet clinically released Tests submitted for 510(k) clearance Tests in development but not yet submitted for clearance Method of endpoint detectionelectrogenicdirect micro-mechanical clot detection, measures actual time required for clottingelectrochemical detection, change in impedance as sample clotsQuality control methods Electronicyesnono (not required, built-in two-level QC on each strip) Liquidyesyesno (not required, built-in two-level QC on each strip) Lyophilizedyes (plasma)

3 Yesno Integrated QC with each analysisyesnoyes Automatic lockout for QC failureyesnoyes Otherlockout for QC failure is for failed electronic QC or per cartridge internal QCvisual confirmation of clot formation Time (in minutes) to perform control plus specimen test PT:3+<11 PT and PTT: ACT:3+ Data-management capabilityoptional add-onnoyesIncludes QCyes yesSystem can automatically transfer data to information system Patient datayesnoyes QC datayesnoyesInterface supplied by instrument vendoryes (additional cost)yesyesLOINC codes transmitted with resultsnono How labs get LOINC codes for reagent kitpackage insertWeb site, package insert, e-mail query Commercially available systems for which interfaces are up and running in active user sitesSunquest, Cerner, Soft, McKesson, Meditech, GE, Siemens, VistA, others CoagClinic from Standing Stone.

4 PPM from AlereLab can control analyzer remotelyyesnonoReal-time wireless linkage to LIS or HISyesnonoPositive identification system ( bar code) for: Patient specimenyesnono Reagentnoyes (each test strip has a bar code, which conveys calibration and control range information)noOnboard system for automatic error detectionyesyes, for sample (volume), reagent stabilityyes, for sample (volume), reagent stabilityTraining provided with instrument purchaseyes (on site)yes (on site)yes (on site)Approx. No. of training hours needed for: Medical staff111 Patient 11 Patient self-testing program is availablenoyes, available through IDTFyesInstrument list price $1, $1,595 professional; $1,995 self-testReagent rental or lease onlynononoCost per sample for: PT: Cost per sample for reagent rentalvaries depends on volume Cost per sample if device purchased $ per strip professional.

5 $10 per self-test PTT: Cost per sample for reagent rental Cost per sample if device purchased ACT: Cost per sample for reagent rental Cost per sample if device purchased CLIA 88 complexity ratingmoderateCLIA-waivedtest-strip waivedUnique advantages (provided by the vendor)Note: a dash in lieu of an answer means company did not answer question or question is not applicablebroad testing menu; many data-management and interfacing options; easy to usemeasures actual time required for clotting; portable monitoring system that directly detects clotting endpoint; system that emulates the WHO reference tilt-tube method; uses fresh capillary whole blood, or venous or recalcified plasma samples; displays PT results in less than 1 minute onboard QC two levels of quantitative controls with reportable results; individually wrapped, non-refrigerated test strips; one-drop fingerstick sample; 12-month dating on test strips; 120-test memory, including QC values; simple three-step test process; human recombinant thromboplastin (ISI )Tabulation does not represent an endorsement by the College of American Pathologists.

6 Survey editor: Raymond Aller, MD30 / CAP TODAY May 2011 Coagulation analyzers point of care, self-monitoringPart 2 of 6 Helena Point of CareHelena Point of CareHelena Point of CareDavid Pearman Pearman Pearman Lindbergh Lindbergh Drive1530 Lindbergh DriveBeaumont, TX 77707 Beaumont, TX 77704 Beaumont, TX 77704800-231-5663800-231-5663 800-231-5663 nameCascade POCA ctalyke XLActalyke Mini IIFirst year sold200820022004No. of units sold in +/200+150+/1,500+No. of units sold in 2010 units sold to: operating room: 40; cardiac cath lab: 45; stat lab: 15; NICU: 15 Country where analyzer instrument POC or self- monitoring analyzer?

7 POC and self- monitoring analyzerPOCPOCS pecimen typefingerstick, venipuncture (whole blood, anticoagulated whole blood, plasma)venipuncture (whole blood)venipuncture (whole blood)Model typehandheld/portableportableportableDim ensions in inches (H W D) 6 6 5 lbSpecimen volume needsaccurate volume required (pipetted)accurate volume required (fill line on cuvette)accurate volume required (fill line on cuvette)Clotting-based tests for which device has FDA-cleared applicationsPT/INR, APTT, Celite ACT, low-molecular-weight heparinactivated clotting time (ACT) whole blood, MAX-ACT: maximum factor XII activation ACT, celite, kaolin, glassACT MAX-ACT, C-ACT, K-ACT, G-ACTT ests using other methodologies for which device has FDA-cleared applications FDA-cleared tests but not yet clinically released Tests submitted for 510(k) clearance Tests in development but not yet submitted for clearancedirect thrombin inhibitor, fibrinogen, heparin/protamine titrationAPTT (whole blood), PT (whole blood), LMWH, heparin, and protamine titration (AMK)LMWH, APTT (whole blood), PT (whole blood)

8 , AMKM ethod of endpoint detectionphoto-mechanicaltwo-point electromechanical soft-clot detection principletwo-point electromechanicalQuality control methods Electronicyesyesyes Liquidnoyesyes Lyophilizedyes (plasma)yesyes Integrated QC with each analysisnonono Automatic lockout for QC failureyesyesno Other data management for entering heparin dose, L-J chart generation for all controls Time (in minutes) to perform control plus specimen test PT:2 PT and PTT:5 ACT:5 125 5 Data-management capabilityonboardyesnoIncludes QCyesyesnoSystem can automatically transfer data to information system Patient datayesyes QC datayesyes Interface supplied by instrument vendoryes (included)interface specifications supplied, POCT1-A compliant LOINC codes transmitted with resultsnononoHow labs get LOINC codes for reagent kitWeb site Commercially available systems for which interfaces are up and running in active user sites Lab can control analyzer remotelynononoReal-time wireless linkage to LIS or HISyesyes Positive identification system ( bar code) for.

9 Patient specimenyesyesno Reagentyesyes; all disposables have bar code for identification with use on any Actalyke modelnoOnboard system for automatic error detectionyesyes, stuck magnet, no tube; mechanical instrument parameters only; well rotation, temperature, and detection settingsyes, for stuck magnet, printer problemsTraining provided with instrument purchaseyes (on site)yes (on site)yes (on site)Approx. No. of training hours needed for: Medical staff30 minutes1 21 Patient Patient self-testing program is availablenononoInstrument list price$3,590$3,805$1,024 (battery only) $1,334 (with printer and battery)Reagent rental or lease onlyyespurchase, lease, or reagent rentalpurchase, lease, or reagent rentalCost per sample for: PT: Cost per sample for reagent rentalvariable Cost per sample if device purchased$ $ PTT: Cost per sample for reagent rentalvariable Cost per sample if device purchased$ $ ACT.

10 Cost per sample for reagent rentalvariable Cost per sample if device purchased$ $ $ $ $ $ 88 complexity ratingnonwaivedmoderatemoderateUnique advantages (provided by the vendor)Note: a dash in lieu of an answer means company did not answer question or question is not applicablemultiple tests, sam