一种国产人类免疫缺陷病毒1型核酸定量检测试剂盒的性能评价

Performance evaluation of a domestic human immunodeficiency virus type 1 nucleic acid quantitative detection kit

目的评估一种国产人类免疫缺陷病毒1型(HIV-1)核酸检测试剂的临床应用性能。方法采集209例临床样本,用梅里埃公司和东北制药集团的HIV定量核酸检测试剂盒同时进行检测,分析两种试剂所得数据的关系。采用Kappa检验方法分析两种试剂的一致性,采用Bland-Altman和配对t检验方法分析两种试剂的相关性。结果东北制药集团和梅里埃公司的Kappa检测值为1.00,因此二者总体符合率为100%。两种试剂盒定量检测结果的相关性分析表明二者的相关性程度较高,检测结果一致,配对t检验显示两种试剂具有等效性。结论东北制药集团的HIV定量核酸检测试剂盒与梅里埃公司的HIV检测试剂盒对同一临床样本检测结果定性具有很高的一致性,同时定量结果的相关性和一致性程度较高。

Objective To evaluate the clinical application performance of a domestic human immunodeficiency virus type 1(HIV-1) nucleic acid detection reagent.Methods A total of 209 clinical samples were collected and tested simultaneously with the HIV quantitative nucleic acid detection kit of Mérieux Company and Northeast Pharmaceutical Group.The relationship between the data obtained by the two reagents was analyzed.The consistency of the two reagents was analyzed by Kappa test, and the correlation between the two reagents was analyzed by Bland-Altman test and paired t test.Results The Kappa detection value of Northeast Pharmaceutical Group and Merier Company was 1.00, so the overall coincidence rate of the two companies was 100%.The correlation analysis of the quantitative test results of the two kits showed that the correlation between the two kits was high, and the test results were identical.The paired t test showed that the two kits were equivalent.Conclusion The results of HIV quantitative nucleic acid test kit of Northeast Pharmaceutical Group and HIV test kit of Mérieux Company for the same clinical sample are qualitatively consistent.At the same time, the quantitative results have a high degree of correlation and consistency.