OF INSTRUMENTSSURVEY Coagulation Analyzers

Diagnostica Stago Inc.Larry Wright larry.wright@stago-us.comFive Century Dr., Parsippany, NJ 07054800-222-COAG www.stago-us.comDiagnostica Stago Inc.Larry Wright larry.wright@stago-us.comFive Century Dr., Parsippany, NJ 07054800-222-COAG www.stago-us.comInstrument name/first year soldSTA Compact Hemostasis System/1996STA Compact CT/2001Start 4/1998No. of units installed in U.S./Outside U.S.No. of contracts signed between 1/1/07 and 11/30/07Country where analyzer designed/ManufacturedOperational typeReagent type—/——France/Francecontinuous random accessopen reagent system (lyoph., reconst. manually)—/——France/Francecontinuous random accessopen reagent system (lyoph., reconst. manually)—/——France/Francebatchopen reagent system (lyoph., reconst. manually)Operates on whole blood or spun plasmaSample handling systemModel typeDimensions (H W D)/Weight/Instrument footprintspun plasmacontinuous specimen access—primary tubebenchtop25.2 38.8 25.8 in/351 lbs/25.6 sq ftspun plasmacontinuous specimen access—primary tubebenchtop25.2 38.8 25.8 in/351 lbs/25.6 sq ftspun plasmamanualbenchtop4.7 16.1 16.5 in/12.5 lbs/1.8 sq ftFDA-cleared clotting-based testsPT, APTT, TT, fibrinogen, reptilase, factors,proteins C & S, lupus anticoagulant, DRVVPT, APTT, TT, fibrinogen, reptilase, factors, proteinsC & S, lupus anticoagulantn/anoneTests submitted for 510(k) clearanceTests in development but not yet submittedPT, APTT, TT, fibrinogen, reptilase, factors,proteins C & S, lupus anticoagulant, DRVV, screeenand confirmheparin (UFH & LMWH), protein C, AT, plasminogen,antiplasminD-dimer, VWF, total & free protein S, AT antigenn/aAPCR, other clotting chromogenic & immunologicaltests with user-defined applicationsnonenonen/an/aAPCR, other clotting tests can have user-definedapplicationsnonenonenonen/adRVVT screen & confirm assays, APCR, otherclotting tests with user-defined applicationsnonenoneMethodologies supportedOper. must load sep. reag. pack for ea. specimen/Test runNo. of different measured assays onboard simultaneouslyNo. of different assays programmed and calibrated at one timeNo. of user-definable (open) channelsOf those defined, No. active simultaneouslyFactor assays require manual manipulation or dilutionsNo. of reag. containers onboard at one time/Tests per containerReagents refrigerated onboardMultiple reag. configurations supportedReag., consumables loaded without interrupting testingSame capabilities when 3rd-party reag. usedMax. time same lot No. of reag. can be usedWalkaway capacity: No. of specimens/No. of testsMin. sample vol. aspirated precisely at one timeStandard specimen vol. required to run PT or PTT/Factor VIII activityDisposables used/Price of eachclotting, chromogenic, & immunologic assaysno/noup to 80up to 807070no45/varies, up to 83yes (15 to 19 C)yesyesyes18 months96/12 per sample5 µL50 µL/5 µLcuvettes & wash-clean solution/varies with volumeclot detection, mechanicalno/noup to 80up to 807070no45/varies, up to 83yes (15 to 19 C)yesyesyes18 months96/12 per specimen5 µL50 µL/5 µLcuvettes & wash-clean solution/varies with volumeclotting testsno/no12041yes4/varies, up to 100noyesnoyes18 months4/125 µL50 µL/5 µLcuvettes, beads, balls/variesSupports direct-from-track samplingPrimary tube sampling supported/Pierces caps on primary tubesSample bar-code reading capabilityReagent bar-code reading capabilityOnboard test automatic inventoryMeasures No. of tests remaining/Short sample detectionClot detection as preanalytical variable in plasma sampleAuto. detection of adequate reag. for aspir. & anal.Hemolysis/Turbidity esno/no (not necessary for mechanical detectiontechnology)yesyes/nonoyes (selectable on menus)noyes/yesyesyesyesyes/yesnoyesno/no (not necessary for mechanical detectiontechnology)yesyes/nonoyes (selectable on menus)nono/no (n/a)nononono/nononono/no (not necessary for mechanical detectiontechnology)nono/nonoyes (selectable on menus)yes/yesyesyes/yesyes/yesno (not necessary)/no (not necessary)yes/yesyesyes/yesyes/yesno (not necessary)/no (not necessary)yes/yesyesyes/yesno/yesnoStat time to completion of all analytes/Throughput per hour for: PT alone PT, PTT Fibrinogen Factor VIII activity assayTime delay from ordering stat to aspir. of sampleAuto. transfer of QC results to LISData management capabilityInterface supplied by instrument vendorInterfaces in active user sites for:Bidirectional interface capabilityResults transferred to LIS as soon as test time completeLOINC codes transmitted with all resultsHow labs get LOINC codes for reagent kitsElectronic interface available (or will be) to automated(or robotic) specimen handling system 6 min/150 specimens7 min/75 specimens7 min/75 specimens7 min/70 specimens 15 secyesonboard (incl. QC: L-J plots)noCerner, Misys, Meditech, othersyes (host query)yesnon/ano 6 min/150 specimens7 min/75 specimens7 min/75 specimens7 min/70 specimens 15 secyesonboard (incl. QC: L-J plots)noCerner, Misys, Meditech, othersyes (host query)yesnon/ano 1 min/up to 120 specimensn/a/n/a 1 min/up to 120 m servicingTime required for maintenance by lab personnelOnboard maintenance recordsTraining provided with purchaseApprox. No. of training hours needed per technodaily: none; weekly: 30 min; monthly: 30 minyesvaries on site, 3 days at vendor offices2 hours basicnodaily: none; weekly: 30 min; monthly: 30 minyesvaries on site, 3 days at vendor office2 hours basicnodaily: none; weekly: 5 min; monthly: 5 minno1 day on site1 hourList priceAnn. svc. contract cost (24/7)/Warranty with purchase 75,000prices available on request/1 yr 50,000prices available on request/1 yr 9,600prices available on request/1 yrUnique advantages (provided by vendors)n viscosity-based detection systemnw alkaway testing for routine and specialtyhemostasis assaysn able to standardize with other STA analyzersn viscosity-based detection systemnw alkaway testing for routine and specialtyhemostasis assaysn able to standardize with other STA systemsn viscosity-based detection systemn e xcellent for low-volume testing or backup foroptical systemn p rogrammable and preprogrammed assays withcurve storage plus four independently timedincubation stationsOFPart 2 of 10Diagnostica Stago Inc.Larry Wright larry.wright@stago-us.comFive Century Dr., Parsippany, NJ 07054800-222-COAG www.stago-us.comFDA-cleared chromogenic testsFDA-cleared immunologic testsOther FDA-cleared testsUser-defined tests in clinical useDilution of patient samples onboardAutomatic rerun capability/Auto reflex testing capabilityLag time during which hypercoagulable samples will not be detectedRead time extended for prolonged clotting timesUser can set different-than-standard: Reag. volumes/Sample volumes No. and sources of reag. Incub. times/Reading timesAutocalibration or autocalib. alert/Multipoint calibration supportedAuto shutdown/Auto startup programmable22 / CAP TODAYJanuary 2008Tabulation does not represent an endorsement by the College of American Pathologists.IN SUST RR VEU YMENTSCoagulation Analyzers

Helena LaboratoriesJoe Golias helena@helena.com1530 Lindbergh Dr., Beaumont, TX 77704800-231-5663 www.helena.comHelena LaboratoriesJim Campbell jcampbell@helena.com1530 Lindbergh Dr., Beaumont, TX 77704800-231-5663 www.helena.comInstrument name/first year soldCascade M/1991Cascade M-4/1992AggRAM/2005No. of units installed in U.S./Outside U.S.No. of contracts signed between 1/1/07 and 11/30/07Country where analyzer designed/ManufacturedOperational typeReagent type300 /100—U.S./U.S.batchopen reagent system200 /25—U.S./U.S.random accessopen reagent system75/100—U.S./U.S.batch, random accessopen reagent systemOperates on whole blood or spun plasmaSample handling systemModel typeDimensions (H W D)/Weight/Instrument footprintspun plasmamanualbenchtop8 15 13 in/25 lbs/1.4 sq ftspun plasmamanualbenchtop8 15 13 in/25 lbs/1.4 sq ftspun plasma, PRPmanualbenchtop6 10 17 in/15 lbs/—FDA-cleared clotting-based testsFDA-cleared chromogenic testsPT, APTT, fib., TCT, factor assays II, V, VII–XIInonePT, APTT, fib., TCT, factor assays II, V, VII–XIInonenonenoneFDA-cleared immunologic testsOther FDA-cleared testsUser-defined tests in clinical usenonenonePT, APTT, fib., TCT, factor assays II, V, VII–XIInonenonePT, APTT, fib., TCT, factor assays II, V, VII–XIITests submitted for 510(k) clearanceTests in development but not yet submittednonedRVVTnonedRVVTnoneristocetin cofactor and platelet aggreg.ristocetin cofactor, platelet aggreg.–ADP, EPI, COL,ristocetin, arach. acidnonenoneMethodologies supportedOper. must load sep. reag. pack for ea. specimen/Test runNo. of different measured assays onboard simultaneouslyNo. of different assays programmed and calibrated at one timeNo. of user-definable (open) channelsOf those defined, No. active simultaneouslyFactor assays require manual manipulation or dilutionsNo. of reag. containers onboard at one time/Tests per containerReagents refrigerated onboardMultiple reag. configurations supportedReag., consumables loaded without interrupting testingSame capabilities when 3rd-party reag. usedMax. time same lot No. of reag. can be usedWalkaway capacity: No. of specimens/No. of testsMin. sample vol. aspirated precisely at one timeStandard specimen vol. required to run PT or PTT/Factor VIII activityDisposables used/Price of eachclot detection, optical, turbidimetricno/no1121yes—/—n/an/anoyes12 monthsnomanual-50 µL100 µL, min. 50 µL/100 µL (dil.), min. 50 µL (dil.)cuvettes/500 @ 54; pipette tips/1,000 @ 82clot detection, optical, turbidimetricno/no4442yes0/n/anononoyes12 monthsnomanual-50 µL100 µL, min. 50 µL/100 µL (dil.), min. 50 µL (dil.)cuvettes/500 @ 54; pipette tips/1,000 @ 82ristocetin cofactor, platelet aggreg.no/no4–84–8124–8yesn/a/n/anononon/a12 monthsnon/aPlt. aggreg.: 225 µL PRP, Risto cofactor: 50 µLcuvettes/200 @ 55.65; pipette tips/1,000 @ 82;stir bars/30 @ 62.25Supports direct-from-track samplingPrimary tube sampling supported/Pierces caps on primary tubesSample bar-code reading capabilityReagent bar-code reading capabilityOnboard test automatic inventoryMeasures No. of tests remaining/Short sample detectionClot detection as preanalytical variable in plasma sampleAuto. detection of adequate reag. for aspir. & anal.Hemolysis/Turbidity detection-quantitationDilution of patient samples onboardAutomatic rerun capability/Auto reflex testing capabilityLag time during which hypercoagulable samples will not be detectedRead time extended for prolonged clotting timesUser can set different-than-standard: Reag. volumes/Sample volumes No. and sources of reag. Incub. times/Reading timesAutocalibration or autocalib. alert/Multipoint calibration supportedAuto shutdown/Auto startup programmablenononononono/no—nono/nonono/noyes (PT: 4 sec, PTT: 14 sec)yes (selectable on menus)nononononono/no—nono/nonono/noyes (PT: 4 sec, PTT: 14 sec)yes (selectable on yes/yesyesyes/yesno/yesno/noStat time to completion of all analytes/Throughput per hour for: PT alone PT, PTT Fibrinogen Factor VIII activity assayTime delay from ordering stat to aspir. of sampleAuto. transfer of QC results to LISData management capabilityInterface supplied by instrument vendorInterfaces in active user sites for:Bidirectional interface capabilityResults transferred to LIS as soon as test time completeLOINC codes transmitted with all resultsHow labs get LOINC codes for reagent kitsElectronic interface available (or will be) to automated(or robotic) specimen handling system3 min/120 specimens7 min/50 specimens3 min/140 specimens7 min/50 specimensn/anono (incl. QC: L-J plots)non/anonono——3 min/140 specimens7 min/80 specimens3 min/160 specimens7 min/80 specimensn/ayesno (incl. QC: L-J plots)no—noyesno—no———n/an/ayesonboard (incl. QC: L-J plots, Westgard)no—noyesno—noModem servicingTime required for maintenance by lab personnelOnboard maintenance recordsTraining provided with purchasenodaily: 10 min; weekly: 10 min; monthly: 20 minno1 day on sitenodaily: 10 min; weekly: 10 min; monthly: 30 minno1 day on site—daily: 15 min; weekly: 15 min; monthly: 1 houryes2 days on siteApprox. No. of training hours needed per tech2–4 hours2 hours4–8 hoursList priceAnn. svc. contract cost (24/7)/Warranty with purchase 7,127 714/1 yr 9,635 966/1 yr 14,995 1,800/1 yrUnique advantages (provided by vendors)n QC program onboardn curve storagen suitable for office lab or as backup analyzern 4-channel manual analyzern QC program onboardn singles or duplicatesn s pecialized coag instrument intended for plateletaggreg. & ristocetin cofactorPart 3 of 10OFHelena LaboratoriesJoe Golias helena@helena.com1530 Lindbergh Dr., Beaumont, TX 77704800-231-5663 www.helena.com24 / CAP TODAYJanuary 2008Tabulation does not represent an endorsement by the College of American Pathologists.IN SUST RR VEU YMENTSCoagulation Analyzers

Y NTVE ER UMSU TRSINFPart 4 of 10Instrumentation Laboratory/Beckman Coulter Inc.Venita Shirley vcshirley@beckman.com200 S. Kraemer Blvd., Brea, CA 92822714-993-8687 www.beckmancoulter.comInstrumentation Laboratory/Beckman Coulter Inc.Venita Shirley vcshirley@beckman.com200 S. Kraemer Blvd., Brea, CA 92822714-993-8687 www.beckmancoulter.comInstrumentation Laboratory/Beckman Coulter Inc.Venita Shirley vcshirley@beckman.com200 S. Kraemer Blvd., Brea, CA 92822714-993-8687 www.beckmancoulter.comInstrument name/first year soldACL Classic Series/1997ACL Elite Series/2006ACL Advance Series/2000No. of units installed in U.S./Outside U.S.4,000 (all models combined)/8,000 (all modelscombined)100 (U.S.)Italy/U.S.random programmingopen reagent systemspun plasmatray-primary tubes or sample cupsbenchtop17.7 29.5 24.8 in/114 lbs/6 sq ft4,000 /8,000 (all models combined)4,000 /8,000 (all models combined)130 (U.S.)U.S./U.S.modified random accessopen reagent systemspun plasmatray-primary tubesbenchtop23.6 36.2 23.6 in/138.6 lbs/6 sq ft150 (U.S.)U.S./U.S.random accessopen reagent systemspun plasmaracks, continuous loading of primary tubesbenchtop32.2 41 24.8 in/185 lbs/15 sq ftFDA-cleared immunologic testsPT, APTT, fib. (Clauss & PT based), TT, factors,protein C/S, lupus (dRVVT), APCR-Vheparin Xa, protein C, AT, plasminogen, plasmininhibitorn/aOther FDA-cleared testsUser-defined tests in clinical useTests submitted for 510(k) clearanceTests in development but not yet submittednonenone—INR plasma setPT, APTT, fib. (Clauss & PT based), TT, factors,protein C/S, lupus (SCT & dRVVT), APCR-Vheparin Xa, protein C, AT plasminogen, plasmininhibitor, factor VIIID-dimer, vWF (Act. & Ag.), free protein S, factor XIIIAg., homocysteinenonenone—INR plasma setPT, APTT, fib (Clauss & PT based), TT, factors,protein C/S, lupus (SCT & dRVVT), APCR-Vheparin Xa, protein C, AT, plasminogen, plasmininhibitorD-dimer, vWF (Act. & Ag.), free protein S, factor XIIIAg., homocysteinenonenone—INR plasma set, global protein C pathwayMethodologies supportedOper. must load sep. reag. pack for ea. specimen/Test runNo. of different measured assays onboard simultaneouslyclot detection, LED optical, (nephelometric);chromogenic; immunologicno/no4clot detection, LED optical (nephelometric);chromogenic; immunologicno/no22No. of different assays programmed and calibrated at one timeNo. of user-definable (open) channelsOf those defined, No. active simultaneouslyFactor assays require manual manipulation or dilutionsNo. of reag. containers onboard at one time/Tests per containerReagents refrigerated onboardMultiple reag. configurations supportedReag., consumables loaded without interrupting testingSame capabilities when 3rd-party reag. usedMax. time same lot No. of reag. can be usedWalkaway capacity: No. of specimens/No. of testsMin. sample vol. aspirated precisely at one timeStandard specimen vol. required to run PT or PTT/Factor VIII activityDisposables used/Price of eachup to 2704no7/varies by testyes (15 C)yesnoyes18 months18/2010 µL50 µL (PT)/40 µLrotors/varies30010020no22/varies by testyes (15 C)yesyesyes18 months40/2605 µLPT: 60 µL/18 µLrotors/variesclot detection, LED optical; chromogenic;immunologicno/novaries with test-reagent combination, limited onlyby No. of reag. positions2007520no42/varies by test, container sizeyes (15 C)yesyesyes18 months120/26410 µL50 µL /10 µLcuvettes/variesSupports direct-from-track samplingPrimary tube sampling supported/Pierces caps on primary tubesSample bar-code reading capabilityReagent bar-code reading capabilityOnboard test automatic inventoryMeasures No. of tests remaining/Short sample detectionClot detection as preanalytical variable in plasma sampleAuto. detection of adequate reag. for aspir. & anal.Hemolysis/Turbidity detection-quantitationDilution of patient samples onboardAutomatic rerun capability/Auto reflex testing capabilityLag time during which hypercoagulable samples will not be detectedRead time extended for prolonged clotting timesUser can set different-than-standard: Reag. volumes/Sample volumes No. and sources of reag. Incub. times/Reading timesAutocalibration or autocalib. alert/Multipoint calibration supportedAuto shutdown/Auto startup oyes (PT & PTT: 5.6 syes (PT & PTT: 3 sec)yesno/nonono/yesno/yesnot neededyes/yesyesyes/yesno/yesnot neededyesyes/yesyesyes/yesno/yesnot neededStat time to completion of all analytes/Throughput per hour for: PT alone PT, PTT Fibrinogen Factor VIII activity assayTime delay from ordering stat to aspir. of sampleAuto. transfer of QC results to LISData management capabilityInterface supplied by instrument vendorInterfaces in active user sites for:Bidirectional interface capabilityResults transferred to LIS as soon as test time completeLOINC codes transmitted with all resultsHow labs get LOINC codes for reagent kitsElectronic interface available (or will be) to automated(or robotic) specimen handling system5.5 min/175 specimens8.5 min/110 specimens5.5 min/175 specimens9.5 min/110 specimens15 secyesyesnomost major LIS vendorsyes (host query)yesno—no4 min/175 specimens8 min/125 specimens4 min/175 specimens8 min/125 specimens15 secyesyesnomost major vendorsyes (broadcast download & host query)yesno—no2.5 min/240 specimens8 min/180 specimens2.5 min/240 specimens8 min/180 specimens20 secyesyesnomost major LIS vendorsyes (broadcast download)yesno—noModem servicingTime required for maintenance by lab personnelOnboard maintenance recordsTraining provided with purchaseApprox. No. of training hours needed per technodaily: 10 min; weekly: 15 min; monthly: 10 minyes2 days on site12 hoursnodaily: 5 min; weekly: 10 min; monthly: 5 minyes5 days at vendor offices24 hoursnodaily: 15 min; weekly: 15 min; monthly: 10 minyes5 days at vendor offices24 hoursList priceAnn. svc. contract cost (24/7)/Warranty with purchase 21,500various options available/1 yr 54,000various options available/1 yr 79,500various options available/1 yrUnique advantages (provided by vendors)n ACL model to fit your testing needsn test menu featuring D-dimern bar-code reagent managementn ACL family harmonizationn e xtensive menu of clotting, chromogenic, andimmunologic assaysn high-end capabilities/small footprintn L ED optics providing optimized results regardlessof preanalytical variablesNo. of contracts signed between 1/1/07 and 11/30/07Country where analyzer designed/ManufacturedOperational typeReagent typeOperates on whole blood or spun plasmaSample handling systemModel typeDimensions (H W D)/Weight/Instrument footprintFDA-cleared clotting-based testsFDA-cleared chromogenic testsJanuary 2008STabulation does not represent an endorsement by the College of American Pathologists.OCoagulation es (PT: 7 sec., PTT: 10 sec)CAP TODAY / 25

Siemens Healthcare DiagnosticsJackie Hauser jacqueline.k.hauser@siemens.com1717 Deerfield Road., Deerfield, IL 60015-0778847-267-5383 www.siemens.com/diagnosticsSiemens Healthcare DiagnosticsJackie Hauser jacqueline.k.hauser@siemens.com1717 Deerfield Road., Deerfield, IL 60015-0778847-267-5383 www.siemens.com/diagnosticsInstrument name/first year soldACL TOP Series/2004BCS XP/2006Sysmex CA-530/2006No. of units installed in U.S./Outside U.S.No. of contracts signed between 1/1/07 and 11/30/07Country where analyzer designed/ManufacturedOperational typeReagent type4,000 /8,000 (all models combined)75 (U.S.)U.S./U.S.continuous random accessopen reagent systemOperates on whole blood or spun plasmaSample handling systemModel typeDimensions (H W D)/Weight/Instrument footprintspun plasmaracks, continuous loading of primary tubesbenchtop28.7 59.4 29.9 in/330.7 lbs/21 sq ft—/——Germany/Germanycontinuous random accessopen reagent system (reconst. manually), optimizedfor Siemens instrumentsspun plasmarackbenchtop37 49 25 in/330 lbs/14 sq ft—/——Japan/Japanbatch, continuous random accessopen reagent system (reconst. manually), optimizedfor Siemens instrumentsspun plasma10-tube position sample rackbenchtop19 21 18.5 in/99 lbs/9 sq ftFDA-cleared clotting-based testsPT, APTT, fib. (Clauss & PT based), TT, factors, lupus(SCT & dRVVT), APCR-VPT, APTT, fibrinogen, TT, reptilase time, protien C clot,factor assaysFDA-cleared chromogenic testsOther FDA-cleared testsheparin Xa, protein C, AT, plasminogen, plasmininhibitorD-dimer, D-dimer HS, vWF (Act. & Ag.), free proteinS, XIII Ag., homocysteinenonePT, APTT, fibrinogen, TT, reptilase time, factorassays, dRVVT screen and confirm, factor V Leiden,protein C clot, protein S activityAT III, plasminogen, factor VIII chromo, alpha-2antiplasmin, protein C chromo, heparin,advanced D-dimernoneUser-defined tests in clinical useTests submitted for 510(k) clearanceTests in development but not yet submittednone—INR plasma set, global protein C pathwayBC von Willebrand-risto. cofactor assay (agglut offixed plts)n/an/aETP (for research use only), Innovance D-dimer,Innovance antithrombinMethodologies supportedclot detection, LED optical, yes (15 C)yesyesyes18 months120/8004 µLPT: 50 µL/25 µLcuvettes/variesclot detection, optical (xenon flasher lamp);chromogenic; immunologicno/no 100 tests/samples997,999 100no90/varies, up to 200yes ( 15 C)yesyesyes12 months100 samples/400 cuvettes

Country where analyzer designed/Manufactured Germany/Germany Germany/Germany France/France . (Beckman Coulter, Bayer LabCell, Roche MPA) . Coagulation Analyzers. Tabulation does not represen