分子诊断定量项目分析性能验证程序探讨

摘要

Objective To explore the verification process for the analytic performance of the quantitative project of molecular di-agnosis.Methods Based on"Medical laboratory accreditation criteria for quality and competence in the field of molecular diagnos-tics application note"(CL-36)(2014)and the relevant documents published by Clinical and Laboratory Standards Institute (CLSI), the performance verification methodology of PCR detection for hepatitis b virus nucleic acid was achieved.for.Results The within-run precision of DNA detection for the hepatitis b virus was 0.109 and 0.105;and the between-run precisionwas 0.1 57 and 0.137. Compared with the reference laboratory,the regression equation was Y =0.947+0.343X ,and the linear correlation coefficient was 0.990.The linear range was 5.00-1.10 and thequantitative detection limit was 500 IU/mL.Hemolysis had no effect on the detec-tion of samples.Conclusion The laboratory with molecular diagnostic program should conduct analytic performance verification,and the appropriate method should be chosen to clear performance verification.Conclusion Clearing the performance indicators of de-tection projects has a very positive role in the clinical use of detection projects..%目的：探讨分子诊断定量项目的分析性能验证程序。方法依据《医学实验室质量和能力认可准则在分子诊断领域的应用说明》和美国国家临床实验室标准化协会(CLSI)颁布的相关文件对实验室开展 PCR 检测乙型肝炎病毒核酸进行方法学性能验证。结果本实验室乙型肝炎病毒核酸(HBV-DNA)检测的重复不精密度(SD)分别为0.109和0.105；日间不精密度(SD)为0.157和0.137；与参比实验室结果比较回归方程为Y =0.947X +0.343,线性相关系数为0.990；线性范围为5.00~1.10；定量检出限为500 IU/mL；溶血对标本检测没有影响。结论实验室开展分子诊断项目应当进行分析性能验证,选择合适的方法可以进行明确的性能验证,明确检测项目性能指标对项目的临床使用有非常积极的作用。