EB病毒核酸定量检测试剂性能验证及评价

The Performance Verification and Evaluation for EB Virus Nucleic Acid Quantitative Detection

目的验证EB病毒核酸定量检测试剂的分析性能是否与厂商提供参数相符从而评估检测指标对于临床的服务能力。方法采用首都医科大学附属北京地坛医院收集的不同浓度的临床标本,对EB病毒核酸定量检测试剂的精密度、准确性、线性范围等性能参数进行方法学性能验证和评价。结果高浓度和低浓度标本的批内精密度CV值(0.58%,2.3%)及批间精密度CV值(2.25%,0.49%)均≤5%,符合要求。准确性验证偏移(1.47%、2.99%、-1.89%、-3.10%、-0.30%和-2.68%)均≤7.5%的标准,符合要求;在7.74×10~6.71×10^6IU/mL分析测量线性范围良好。结论通过验证,EB病毒核酸定量检测试剂可以满足目前EB病毒的筛查和临床疗效监测的需要,适用于临床常规检测。

Objective To verify the consistency between the analytical performance of the EB virus(EBV)nucleic acid quantitative detection reagent and the parameters provided by the manufacturer,and to evaluate the clinical service capacity of the kit.Methods We collected clinical specimens of different concentrations from Beijing Ditan Hospital.The performance verification and evaluation were carried out based on the parameters including:precision,accuracy and linear range of EBV nucleic acid quantitative detection reagents.Results The intra-assay precision CV values(0.58%,2.3%)and inter-assay precision CV values(2.25%,0.49%)of high-concentration and low-concentration specimens were all ≤5%,which met the requirements.Correctness verification offsets(1.47%,2.99%,-1.89%,-3.10%,-0.30% and -2.68%)were all ≤7.5% of the standard,which met the requirements as well.Measurement linear range was between 7.74×10 and 6.71×10^6 IU/mL.Conclusion The EBV nucleic acid quantitative detection reagent can meet the needs of current EBV screening and clinical efficacy monitoring,and is suitable for clinical routine detection.