HBV DNA一步法定量检测性能验证及评价

摘要

Objective To evaluate analytical perfortnance and clinical application value of a one-step HBV DNA quantitative detecting system.Methods Analytical performance of the one-step HBV DNA quantitative detecting reagents included precision,residual contamination,accuracy,functional sensitivity and analytical measurement range were verified by collecting high concentration samples and external quality control samples from Jiangsu provincial clinical test center.Results The within-run coefficient of variation (CV) of both low and high concentration samples were below 5％,meanwhile the intra-assay CV was below 3/5 TEa and inter-assay CV was below 4/5 TEa.There was no residual contamination and the analytic accuracy met the requirement of external quality assessment (EQA).Functional sensitivity was able to attain 100 IU/ml,while the day to day CV was below 20％.It exhibited a benign Iinear relation from 7.58 × 101 to 7.58 × 108 [U/ml.Conclusions The analytic performance of a new testing system must be evaluated particularly before detecting samples of patients by quantitative tests.This study proves that the one-step HBV DNA quantitative detecting reagents can meet requirement of hepatitis B screening and clinical therapy monitoring,which is economic and simple for clinical routine tests.%目的 评估一步法HBV DNA定量检测试剂的分析性能及其临床应用价值.方法 采用江苏省临床检验中心室间质控品和南京医科大学附属逸夫医院收集的高浓度临床标本,对一步法HBV DNA定量检测试剂的精密度、标本携带污染、正确度、功能灵敏度、分析测量范围等性能参数进行方法学性能验证和评价.结果 低浓度和高浓度标本的批内CV均≤5％,且重复性精密度＜3/5TEa,中间精密度＜4/5 TEa;无标本携带污染;正确度符合江苏省室间质评要求;功能灵敏度可以达到100 IU/ml,天间重复CV值≤20％;在7.58×101 ～ 7.58×108 IU/ml分析测量范围线性关系良好.结论 定量检测项目在正式用于患者标本检测前必须对检测系统的分析性能做详细充分的评价,通过验证一步法HBV DNA定量检测试剂可以满足目前乙肝筛查和临床疗效监测的需求,并且经济简便,适用于临床常规检测.