CLSI-EP06-A(定量分析方法的线性评价).docxVIP

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CLSI-EP06-A(定量分析方法的线性评价).docx

April2003

EP06-A

EvaluationoftheLinearityofQuantitativeMeasurementProcedures:AStatisticalApproach;ApprovedGuideline

Thisdocumentprovidesguidanceforcharacterizingthelinearityofamethodduringamethodevaluation;forcheckinglinearityaspartofroutinequalityassurance;andfordeterminingandstatingamanufacturer’sclaimforlinearrange.

AguidelineforglobalapplicationdevelopedthroughtheClinicalandLaboratoryStandardsInstituteconsensusprocess.

Clinical

ClinicalandLaboratoryStandardsInstitute

TheClinicalandLaboratoryStandardsInstitute(CLSI)is

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