美康血球10 qc calib说明

QualityControl&CalibrationNovember30,2010ScientificAffairsAtsushiShirakami,ToshikazuKasaiXN-seriesGlobalTrainingForum(GTF)InternationalBusinessManagement1ContentsIntroduction-QC&CalibrationConceptMaterials(Specifications)Controls-XNCHECK/XNCHECKBFCalibrator-XNCAL/XNCALPFBasicFunctionQCProgramCALProgram(Calibrator-Calibration)NewFeaturesAssay-DownloadSystemGlobalAssay(underdiscussion)InternationalBusinessManagement2Introduction–Topicsfrom1stGlobalQCMeetingatSAI

GlobalQCMeeting

Date:October12-13,2010

Puropose:ToshareglobalQC-relatedissuesanddiscussfutureactionsInternationalBusinessManagement3Retic-discrepancycomplaintsfromglobalmarketRegionCountryQCHF#(Reportedon)TitleAPTaiwanS310B056(Feb-16-10)XE-5000RETDataDiscrepancyinCapSurveyRT-4AEUSwedenDenmarkS310D023-27(Apr-8-10)XT-SeriesreportsmuchtoohighRETcountcomparedtoXE-SeriesUSUSS310C041(Mar-10-10)XT-2000iCalibrationofRET%EU/USGlobal(WADA)SAI/SEG(Apr-22-10)20WADAarreditatedlabsuseXT-2000i.WADAlabsrequestedSysmextovalidateaccuracyofRet%.USUS(LabCorp)SAI(May-25-10)LabCorpdissatisfiedwiththeapparentbiasbetweenXTandXE’sreticulocyterecoveryduringcorrelation.(asofMay27,2010)InternationalBusinessManagement4WADA&LabCorpModelNMeanSDXE-5000784.82.7XE-2100C3199.66.7XT-2000i9124.04.3

WADAAccreditatedLabscomplainedaboutRet%resultsforXTs?(May11,2010AsahiShinbun)LabCorpsuspectedRet%discrepancybetweenXTsandXE-2100C/XE-5000CheckedRET_CALfactorsfortheLabCorpanalyzersatKakogawafactory;

InternationalBusinessManagement5TraceabilityChainforRet%(XE-series)InternationalBusinessManagement6USNHinOkinawa<SpecialLetterfromDOD>

-CeaseOrderforPatientTestingbyunsatisfactoryPTperformance-

UnsatisfactoryResultsforCAPSurveysecondtestingeventonthesameanalyte;

MCV,HCT,RDW-SDover+3SDIforallXT’sinUSNHTheirXT’swereperiodicallycalibratedbyourFSR(SCS-Pack).CountermeasureRe-calibratealltheirXT’sbasedon;X-CALwithUSAssayValuesVerifiedwithInsightPeerMeanRe-calibratedinJan-10andAug-10InternationalBusinessManagement7

LaboratoryAccreditation-ISO15189>“traceability”-CAP>moreinAsia

GlobalizationofHeathcareService-WADA–Reticissue-MedicalTourisminAsia-USNH–CAPsurveyBackground–CurrentSituationExternalEnvironment

“Region-oriented”QCManagement-AssaySystembySEG,SAI&S-Corp-QC/CalSystemSNCS/eQAPi,Insight/Calprogram-Calibrator(SCS-1000/X-CAL)

ExcellentService&Support-well-operatedbyeachregion

inSysmex

Provideglobally-harmonizedQC&CalsystemforXN-seriescustomers.QCmaterials(Controls/Calibrators)QC/CalProgramAssaySystemInternationalBusinessManagement8“Reliability”“Traceability”“Usability”Enhance“ProductLine-up”XNCHECKXNCAL/XNCALPFXNCHECKBFIntroduce“ICT”forXNAUTO-QCFunctionCalibrationProgramSensitivityAdjustmentPromote“Harmonization”

Assay-DownloadSystemUniversalAssaysforXNCALQC&CalibrationConceptforXN-seriesInternationalBusinessManagement9QCMaterialsControlsXNCHECKXNCHECKBFCalibratorsXNCALXNCALPFInternationalBusinessManagement10Controls&Calibrators–ScopeofapplicationsWDFWNRWPCRET/PLT-ORBC/PLTHGBPLT-FMajorParmaeterWBC-DNEUT#/%LYMPH#/%MONO#/%EO#/%IG#/%WBCBASO#/%WBC-PHPC#RET#/%L/M/HFRIRFRET-HeRBC-OPLT-ORBC,PLTHCT,MCVMCH,MCHCRDW,PDWHGBPLT-FIPFControlCalibratorXNCHECK(Level1-3)XNCALXNCALPFChXNCHECKBF(*ForBodyFuidmode)InternationalBusinessManagement11Controls&Calibrators–comparisontoXE-seriesCBCQCSCS-1000XNCALXE/XT/XSXN-seriesXNCHECKe-CHECKseriesCountCalibraitonSensitivityAdjustmentX-CAL(inUS)FreshWholeBlood

SameMaterialInternationalBusinessManagement12FeaturesofXNCHECK–BasicSpecifications(1)AssayParameters:CBC8parameters+RDW-SD/CV,PDW,PCT,MPV,P-LCRWBC-D,WBC-P,5-DIFF#/%,IG#/%,NRBC#/%PLT-F,IPFRet#/%,LFR/MFR/HFR,IRF,Ret-He,RBC-O,PLT-OLevel:-3levels(Level1,2,3)Stability:ClosedVialStability(CVS)–94daysOpenVialStability(OVS)–7daysVolume:-3.0ml/vialInternationalBusinessManagement13FeaturesofXNCHECK–BasicSpecifications(2)Materials:Basicallysamease-CHECK(XE),exceptforPLTofLevel1

>NewPlateletecomponentcanbestainedbyPLT-FstainWBCRBCRETNRBCPLTLevel1Samease-CHECK(XE)NewLevel2,3Samease-CHECK(XE)Level1Level2Level3ComparisonofPLT-FscattergramsforXNCHECK(L1-3)SFLFSCInternationalBusinessManagement14WholeBlood(Ref.)Level1Level2Level3WBC-D(x103/µL)1.5-3.56–1015-26NEUT%(%)LYMPH%(%)MONO%(%)EO%(%)30.0–70.010.0–50.05.0–20.06.0–14.0AssayParametersWBC-D,NEUT#/%,LYMPH#/%,MONO#/%,EO#/%ScattergramSpecificationsAboutXNCHECK–WDRScattergramSSCSFLLYMPHMONONEUT+BAEOInternationalBusinessManagement15AboutXNCHECK–WNRScattergramWholeBlood(Ref.)Level1Level2Level3WBC(x103/µL)1.5-3.56–1015-26NRBC(x103/µL)0.1–0.20.32–0.800.82–1.64AssayParametersWBC,BASO#/%,NRBC#/%ScattergramSpecificationsNRBCWBCFSCSFLBASOInternationalBusinessManagement16AboutXNCHECK–WPCScattergramWholeBlood(Ref.)Level1Level2Level3WBC-P(x103/µL)1.5-3.56–1015-26AssayParametersWBC-PScattergramSpecificationsSSCSFLInternationalBusinessManagement17AboutXNCHECK–RETScattergramWholeBlood(Ref.)Level1Level2Level3RET%(%)4.5-7.51.5–3.50.5–1.5IRF(%)HFR(%)10–601–2010–601–2010–601–20AssayParametersRET#/%,LFR,MFR,HFR,IRF,RBC-O,RET-He,(PLT-O)ScattergramSpecificationsFSCSFLInternationalBusinessManagement18AboutXNCHECK–PLT-OScattergramWholeBlood(Ref.)Level1Level2Level3PLT-O(x103/µL)30–120190-270400-720AssayParametersPLT-OScattergramSpecs.FSCSFLInternationalBusinessManagement19AboutXNCHECK–PLT-FScattergramWholeBlood(Ref.)Level1*Level2Level3PLT-F(x103/µL)35–65190-270400-720AssayParametersPLT-F,IPFScattergramSpecs.FSCSFL*NewplateletcomponentisusedforLevel1tomonitorlowPLTcountonPLT-FCh.AsforLevel2and3,samematerialisusedase-CHECK(XE).InternationalBusinessManagement20AboutXNCHECK–AssaySheetPoints!

Onlyone-modeassay>nomoreM2Madjustment!

NoAssaysforSensitivity>nouseforsensitivityadj.InternationalBusinessManagement21AboutXNCHECK–PackagingConfigurationsPackaging:basicallysamease-CHECK(XE) *incaseof8weeksproductioncycleinStreckRegionLevelPackagingconfigurationJP2levels

(L1,L2)Bulkshipment

9vials/Level*DesignedandPackedinOnofactoryUS3levels

(L1,L2,L3)4vialsLevelspecificset/Clamshell12vials(Trilevelx3vials)/ClamshellEU3levels

(L1,L2,L3)Bulkshipment(forspecificareaonly)8vialsLevelspecificset/ClamshellCH/AP3levels

(L1,L2,L3)8vialsLevelspecificset/ClamshellInternationalBusinessManagement22FeaturesofXNCHECKBF–BasicSpecifications(1)IntentedUse:-QCforBF(BodyFluid)moduleAssayParameters:WBC-BF,MN#/%,PMN#/%,TC-BF#(forWDFch)RBC-BF(forRBC-Ich)*measuredonBFmodeMaterial:Cell-ChexAuto(Streck)Level:2levels(Level1,2)Stability:ClosedVialStability(CVS)–75daysfromthe1stdayoftheshipmentOpenVialStability(OVS)–30daysVolume:-3.0ml/vialInternationalBusinessManagement23AboutXNCHECKBF–WDFScattergramBodyFluid(Ref.)Level1Level2WBC-BF(x103/µL)MN%PMN%RBC-BF(x106/µL)7.5–12.520–8020–800.01–0.0524.0–36.020–8020–800.01–0.05AssayParametersWBC-BF,MN#/%,PMN#/%,TC-BF#RBC-BF(fromRBC-I)ScattergramSpecs.SSCSFLMN#/%PMN#/%InternationalBusinessManagement24AboutXECHECKBF–PackagingConfigurationsPackaging(3vials/clamshellissameconfiguration

asCell-ChexAuto)

RegionLevelPackagingconfigurationJP2levels

(L1,L2)Bulkshipment

*(TBD)*vials/Level*DesignedandPackedinOnofactoryUS2levels

(L1,L2)3vialsLevelspecificset/ClamshellEU2levels

(L1,L2)Bulkshipment(forspecificareaonly)3vialsLevelspecificset/ClamshellCH/AP2levels

(L1,L2)3vialsLevelspecificset/ClamshellInternationalBusinessManagement25FeaturesofXNCAL–BasicSpecifications(1)AssayParameters:WBC,WBC-D,WBC-P,RBC,RBC-O,PLT,PLT-O,RET%,HCT,HGB(forCustomer)Aboveparameters+SensitivityParamters*

*WNR-X,-Y,WDF-X,-Y,WPC-X,-Y,RBC-X,-Y,RBC-X(PLTF),RBC-Y(PLTF)Level:-1levelStability:ClosedVialStability(CVS)US:about45days(fromStreckshipment)EU/AP:about50days(fromStreckshipment)JP:about60days(fromStreckshipment)OpenVialStability(OVS)–4hoursVolume:-3.0ml/vialMaterial:Samease-CHECK(XE)InternationalBusinessManagement26XNCALNotesScattergramSpecificationsWBC(x103/µL)6.0–10.0AssayParametersCountCalibrationWBC-DSensitivityAdjustmentWDF-X,WDF-Y,(WDF-Z)WDF-X,WDF-Yの位置は？AboutXNCAL–WDRScattergramWholeBloodSSCSFLInternationalBusinessManagement27AboutXNCAL–WNRScattergramXNCALNotesScattergramSpecificationsWBC(x103/µL)6.0–10.0AssayParametersCountCalibrationWBCSensitivityAdjustmentWNR-X,WNR-Y(WNR-Z)WNR-X,WNR-Yの位置は？WholeBloodSFLFSCInternationalBusinessManagement28AboutXNCAL–WPCScattergramXNCALNotesScattergramSpecificationsWBC(x103/µL)6.0–10.0AssayParametersCountCalibrationWBC-PSensitivityAdjustmentWPC-X,WPC-Y,(WPC-Z)WPC-X,WPC-Yの位置は？WholeBloodSFLSSCInternationalBusinessManagement29AboutXNCAL–RETScattergramXNCALNotesScattergramSpecificationsRET%(%)1.5–3.5AssayParametersCountCalibrationRET%,RBC-O,PLT-OSensitivityAdjustmentRBC-X,RBC-Y,(RBC-Z)WholeBloodFSCSSCRBC-XRBC-YInternationalBusinessManagement30AssaySheetsofXNCALa)ForCustomers

b)ForFSRsCountCalibraiton(CBC+Ret%)CountCalibraiton(CBC+Ret%)

SensitivityAdjustmentInternationalBusinessManagement31FeaturesofXNCALPF–BasicSpecifications(1)AssayParameters:PLT-FLevel:-1levelStability:ClosedVialStability(CVS)US:about45days(fromStreckshipment)EU/AP:about50days(fromStreckshipment)JP:about60days(fromStreckshipment)OpenVialStability(OVS)–4hoursVolume:-3.0ml/vialInternationalBusinessManagement32AboutXNCALPF–PLT-FScattergramXNCALPFNotesScattergramSpecificationsPLT-F(x103/µL)170–230AssayParametersCountCalibrationPLT-FSensitivityAdjustmentRBC-X(PLTF),RBC-Y(PLTF)PLTF-ZItshouldbedonebyXNCAL?WholeBloodSFLFSCInternationalBusinessManagement33AssaySheetsofXNCALPFPoints!

OnlyPLF-Fassay

NoAssaysforSensitivity>nouseforsensitivityadj.InternationalBusinessManagement34Packaging2typesofPackages:XNCalandXNCalPFAboutXNCAL/XNCALPF–PackagingConfigurationsRegionPackagingconfigurationNoteXNCALXNCALPFJPBulkshipmentBulkshipmentSamevial#asSCS-1000US1x3.0mlcustomerset5x3.0mlFSRKit1x3.0mlcustomerset5x3.0mlFSRKitSamevial#asX-CALEU3x3.0mlcustomersetBulkshipment3x3.0mlcustomersetBulkshipmentSamevial#asSCS-1000CH/AP3x3.0mlcustomerset3x3.0mlcustomersetSamevial#asSCS-1000PackagingconfigurationisnotfixedInternationalBusinessManagement35Summary(1)-XNControlProductsLine-upCategoryProductNameOverviewScienceConfigurationsPackagingControlsXNCHECKe-CHECK(XE)L1=PLT-F(35-65103/µl)SamealgorithmCount+ScattergramsforallL1,L2andL3PLT-I,OandFCVS:94days(TBCbybeginNov2010)OVS:7days3.0ml/vial88µl93days:samease-check(XE)8weeksproductionIf100,maybechanged?CalibratorXNCale-check(XE)L2GlobalLot&procedure-FDAandCEMarkAllSensitivitiesAllCountexceptPLT-FCVS:45daysOVS:4hoursSeparatepackagesforIandIIXNCalPFNoWBCorNRBCComponentGlobalLot&procedure-FDAandCEMarkPLT-FCountonlyLowRBCsincludedItalicpartistentativenamingInternationalBusinessManagement36Summary(2)-XNControlProductsLine-up

CategoryProductNameOverviewScienceConfigurationsPackagingBodyFluidControlXNCHECKBFBrandingincludedvolumetiedtoUFControlCellChexAutoAssayallparameters(CellChexAuto)3.0ml/vialCVS:75daysOVS:30daysL1,L2LinearityCheckRangeCheckXIILikeRangeCheckXIIPLT-FneededforPLTRBCandWBCaresameasRCXIICVS:84daysOVS:5days2.0ml/vial6Levelsx3:18vialsRetic-ChexLinearityBrandingReticOnly2.5ml/vial5LevelsItalicpartistentativenamingInternationalBusinessManagement37QC&CalibrationProgramInternationalBusinessManagement38QCProgram(XE-Seriesvs.XN-Series)XE-SeriesXN-SeriesQCfilesMax.#offilesX-bar/L-JX-barMPlots/file25files24files1file180plots99files94files5files300plotsQCSettingManualsettingReadfromCDFiledownloadAutomaticRegistration○○××○○○○OthersQCComparison×○InternationalBusinessManagement39Majorimprovedpoints

Auto-QCFunction-Assay-downloadvianetwork

QCFileScreen

-IncreasednumberoffilesRadarChartsToolbarEnter/displaycommentsChart-OverlayFunction-bylevels/byanalyzers(modules)QCProgram–Increasing“Usability”InternationalBusinessManagement40Auto-QCFunction(1)1．Delivery2．Registeration3．PerfomingQCReceiveaCD-ROMincludingAssayInfo.withe-CHECKXE-SeriesXN-SeriesNotnecessaryforRegistrationReceiveassayinformationautomaticdallyvianetworkwhenanewlotismeasured.Customerneedstoconfirm…ReceivenewlotofXNCHECKw/oCD-ROMRegisterlotinfo.fromaCD-ROMtoIPUInternationalBusinessManagement41QCFileScreenQCfilelist–99filesavailableRadarChartsQCProgramInternationalBusinessManagement42RadarChartDisplaysthelatestplotdatafromtheselectedQCfileAnypointsexceedingtheupperorlowerlimitismarkedwithared“X”.QCProgramInternationalBusinessManagement43QCChartScreenToolbar(Regist./Modify/Manage/Vials/DisplayComments…)QCProgramInternationalBusinessManagement44QCChartScreenToolbar(Regist./Modify/Manage/Vials/DisplayComments…)QCProgramInternationalBusinessManagement45Chart-displayarea

Commentmark/Commentmark–enter&displaycommentsVialline-vial-openQCProgramInternationalBusinessManagement46Chart-OverlayFunctionComparisonbetweenlevelsComparisonbyanalyzers(modules)QCProgrambylevelbyanalyzer(module)InternationalBusinessManagement47Chart-OverlayFunctionComparisonbetweenlevelsComparisonbyanalyzers(modules)QCProgramInternationalBusinessManagement48CalibrationProgram(Calibration)(Precision-Check)Calibration–XNCALCalibation–XNCALPFInternationalBusinessManagement492-stepprocessPrecisionCheck&CalibrationCalibrationProgramPrecision-checkCalibrationInternationalBusinessManagement50Calibrator-CalibrationScreenRunXNCAL,11times>1stresultwillbedeletedfromcalculationCalibrationProgramInternationalBusinessManagement51Calibrator-CalibrationScreenMean,SD,CVarecalculatedanddisplayedCalibrationProgramInternationalBusinessManagement52Calibrator-CalibrationScreen

Read“TargetValues”vianetworkCalibrationProgramInternationalBusinessManagement53CalibrationProgramCalibrator-CalibrationProgram

XNCALmeasurementresultsarecomparedtotargetvaluesanddisplayed;ServiceLimit(%)CalibrationLimit(%)InternationalBusinessManagement54CalibrationProgramCalibrator-CalibrationProgramChangeCOCusingthefollowingscreen,InternationalBusinessManagement55CalibrationProgramCalibrator-CalibrationProgramChangeCOCusingthefollowingscreen,InternationalBusinessManagement56Calibrator-CalibrationScreenforPLT-FRunXNCALPF,11times>1stresultwillbedeletedfromcalculationCalibrationProgramInternationalBusinessManagement57AdvantageofusingGlobalLotCalibrators(XNCAL/XNCALPF)StandardAnalayzersGlobalLotItisthetimetoharmonizeandstandardizeourcustomersdataglobally!!CustomersCustomersCustomersCustomersSAISEGS-CorpInternationalBusinessManagement58ProposalfromScientificAffairs(S-Corp)

-tomeet

ExpectationfromGlobalMarket-CalibrationforCustomerBaseUseXN-CALforAdjustmentatKakogawafactoryAdjust/CalibrateallunitswithXN-CALAssayValuesDonotcomparisonadjustmentagainsttheKakogawa’sstd.analyzerIntroduce“Universal”AssaysforXN-CALHarmonize/StandardizeallXNswith“one”assaygloballyInvestigatethepossiblitiestoachievethischallenge!!Harmonizecalibration/adjustmentproceduresat:Kakogawa