CLSI-EP21-A(临床实验方法总分析误差的评价).docxVIP

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CLSI-EP21-A(临床实验方法总分析误差的评价).docx

EP21-A

EP21-A

Vol.23No.20

ReplaceEP21-PVol.22No.2

EstimationofTotalAnalyticalErrorforClinicalLaboratoryMethods;ApprovedGuideline

Thisdocumentprovidesmanufacturersandenduserswithameanstoestimatetotalanalyticalerrorforanassay.Adatacollectionprotocolandananalysismethodwhichcanbeusedtojudgetheclinicalacceptabilityofnewmethodsusingpatientspecimensareincluded.Thesetoolscanalsomonitoranassay’stotalanalyticalerrorbyusingqualitycontrolsamples.

AguidelineforglobalapplicationdevelopedthroughtheNCCLSconsensusprocess.

NCC

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