HBV-DNA试剂盒检测下限及线性范围下限精密度的性能评估

Performance Evaluation of HBV-DNA Quantitative Detection Kit

针对某厂家乙型肝炎病毒核酸(Hepatitis B virus nucleic acid,HBV-DNA)定量测定试剂盒声明的检测下限及线性范围下限的批内精密度进行补充评估,以保证检验结果的可重复性以及检验报告的准确性。参照CNASGL037《临床化学定量检验程序性能验证指南》、CNAS-GL039《分子诊断检验程序性能验证指南》以及中华人民共和国医药行业标准YY/T 1182-2010《核酸扩增检测用试剂(盒)》,基于ABI STEPONE PLUS实时荧光定量PCR仪检测某厂家HBV-DNA定量测定试剂盒声明的检测下限浓度(30 IU/mL)和线性范围下限浓度(100 IU/mL)的临床血清样本,进行相关性能评估。本次评估结果显示检测下限浓度为50 IU/mL(20次检测结果检出率≥90%),线性范围内最低检测浓度水平为300 IU/mL(变异系数CV<5%),与某厂家HBV-DNA定量测定试剂盒申明的检测下限不相符,批内CV<5%不能覆盖整个线性范围,故本实验室根据评估结论完善了HBV-DNA定量测定结果的审核规则,以保证检验结果的可重复性以及检验报告的准确性,为临床提供更有效的服务。

Evaluating the detection limit and precision of lower limit of linear range declared by the quantitative test kit for hepatitis B virus nucleic acid(HBV-DNA),to ensure the repeatability of results and the accuracy of the report.According to CNAS-GL037 guide for performance verification of clinical chemistry quantitative test procedure,CNAS-GL039 guidance on the performance verification for molecular diagnostic procedures and YY/T 1182-2010 guide for nucleic acids amplification test reagents(kits),using ABI STEPONE PLUS realtime fluorescence quantitative PCR instrument,the clinical serum samples with detection limit concentration(30 IU/mL)and lower limit concentration of linear range(100 IU/mL)were detected.The test results were recorded and the performance was evaluated.For this evaluation,the detection limit concentration was 50 IU/mL(detection rate of 20 detection results≥90%),and the lowest detection concentration level within the linear range was 300 IU/mL(CV<5%).Therefore,the detection limit of the HBV-DNA quantitative detection kit does not conform to the manufacturer’s statement and CV<5%in the batch precision cannot cover the whole linear range.According to the evaluation results,our laboratory has performed the audit rules of HBVDNA quantitative test results,so as to ensure the repeatability of the results and the accuracy of the report,and provide more effective services for the clinic.