分子诊断检验程序性能验证指南

2019021520190215CNAS-GL039GuidanceonthePerformanceVerificationforMolecularDiagnosticProceduresCNAS-GL039:20191112019021520190215CNASCNAS-CL022012CNAS-CL02-A0092018CNAS-GL039:201921120190215201902151PCRSanger(NGS)/2WS/T420-2013WS/T492-2016WS/T505-2017YY/T1261-2015HER2YY/T1459-20163GB/T29791.1-2013/ISO18113-120093.1reportablerange[GB/T29791.1-2013/ISO18113-120093.461]4.4.1CNAS-GL039:201931120190215201902154.1.14.1.24.1.34.2PCRSanger(NGS)PCRPCRSangerNGS/4.3CNAS-GL039:2019411201902152019021555.15.25.35.45.55.6,5.766.16.1.16.1.1.1ISO151896.1.1.2CNAS-GL039:20195112019021520190215a5/1012/3/baba+bcdc+da+cb+da+b+c+d=a/(a+c)100%=d/(b+d)100%=(a+d)/(a+b+c+d)100%6.1.1.34.36.1.26.1.2.16.1.2.2aCNAS-GL039:20196112019021520190215b520546.1.2.35100%20181NGSSangerSNVindelCNVSV5395%2/5490%6.1.56.1.36.1.3.16.1.3.2CNAS-GL039:20197112019021520190215336.1.3.36.1.46.1.4.1G6.1.4.213210%36.1.4.3126.1.56.1.5.1200CNAS-GL039:201981120190215201902156.1.5.25501006.1.5.390%6.2CNAS-GL0376.3PCRNGS6.3.16.3.1.16.3.1.2aA260/280b2A10%BAB=BA100%CNAS-GL039:20199112019021520190215c6.3.1.3aDNAA260/2801.7-1.9RNAA260/2801.8-2.0bc6.3.26.3.2.1PCR6.3.2.2104-6CtKEE=10-1/K-16.3.2.390%110%6.3.36.3.3.16.3.3.2DNA6.3.3.3CNAS-GL039:2019101120190215201902156.3.46.3.4.16.3.4.2SNVindelindel6.3.4.395CNAS-GL039:2019111120190215201902151.CNAS-CL0220122.CNAS-CL02-A00920183.WS/T505-20174.YY/T1182-2010()5.CLSIEP12-A2:UserProtocolsforEvaluationofQualitativeTestPerformanceApprovedGuideline-SecondEdition.6.()2015-7-37.201734638.CLSIMM06-A2:QuantitativeMolecularMethodsforInfectiousDiseases;ApprovedGuideline-SecondEdition.9.CLSIMM03-A3:MolecularDiagnosticMethodsforInfectiousDiseases-ThirdEdition.