国内某人类免疫缺陷病毒I型(HIV-1)核酸检测试剂盒的自动化应用性能评估

Evaluation of the automatic application performance of a quantitative nucleic acid detection kit for HIV-1

目的对国内某人类免疫缺陷病毒Ⅰ型(HIV-1)核酸定量检测试剂盒的自动化应用性能进行评估。方法收集150份血液样品,用待评试剂和参比试剂及自动化设备进行双盲检测。2种试剂定性结果用符合率和卡方检验等统计方法分析;2种试剂的定量结果用相关性分析、回归分析等统计方法分析。结果 2种试剂检测结果的总体符合率为100.00%,Kappa值为1.00。2种试剂盒定量检测结果的相关性分析显示2种试剂检测结果一致,配对t检验显示2种试剂具有等效性。结论待评试剂和参比试剂对同一血液样本检测结果具有较高的定性符合率、较强相关性以及定量一致性。

Objective To evaluate the performance of the automated application of a kind of domestic nucleic acid quantitative detection kit for human immunodeficiency virus type I（ HIV - 1 ）. Methods 150 blood samples were collected, and the double blind test was carried out with the reagent and reference reagent. The qualitative results of two kinds of reagents were analyzed by statistical methods such as the coincidence rate of the results and the chi square test. The quantitative results of the two kinds of reagents were analyzed by correlation analysis and regression analysis. Results The total coincidence rate of the two reagents was 100.00% and the Kappa value was 1.00. The correlation analysis of the two kinds of reagent kits showed that the results of the two tests were consistent. The paired t test showed that the two reagents have the same equivalence. Conclusion Through testing the same blood sample, the results of the reagent to be evaluated and the reference reagent have higher qualitative coincidence rate, strong correlation and quantitative agreement.