某种人类免疫缺陷病毒I型核酸定量检测试剂盒的性能评估

目的对某种人类免疫缺陷病毒I型（HI-1）核酸定量检测试剂盒（PCR．荧光探针法）的临床应用性能进行评估。方法收集不同HIV感染状态人群的血液样品共计109份，分别使用HIV-1被评估试剂与参比试剂的核酸定量检测试剂盒进行平行对比试验。统计学处理使用Kappa值、砰和Bland—Ahman模型。结果被评估试剂检测结果相对于参比试剂，检测结果的总符合率为97．25％（95％CI：92．17％-99．43％），Kappa值为0．92（P〈0．001），一致性强度为最强。109例样本中，均在被评估试剂与参比试剂定量检测范围内的样本为84例，两种试剂盒检测结果的回归分析表现出较强的相关性（R2=0．8536）。使用Bland—Altman模型比较两种试剂检测结果的差异均值，结果显示对于未进行抗病毒治疗的HIV感染者样本两种试剂检测结果具有较好的一致性。结论被评估试剂和参比试剂对同一份血浆样本检测结果具有较好的定性符合程度和较强的相关性，对HIV感染者样本两试剂检测结果有较强的定量一致性。

Evaluation of a new quantitative detection kit for human immunodeficiency virus typel RNA

Objective To evaluate the variation and stability of a new quantitative detection kit for human immu- nodeficiency virus type 1 （ HIV-1 ） nucleic acid. Methods A total of 109 plasma samples were detected by both the evalu- ated kit and the COBAS Taqman analyzing system. The results of the two methods were compared by kappa number, R square and Bland-Airman plot. Results The consistency of the evaluated kit with the reference kit was 97.25% （95% CI： 92. 17% -99.43% ） ,and Kappa value was 0.92 （P 〈0. 001 ）. Out of 109 paired plasma tested, 84 samples were quantifi- able by both kits. There was a strong overall correlation of the test results between the two methods （R2 =0. 853 6）. Com- parison of the mean test results with differences of the two methods using the Bland Altman plot showed that there were good consistency between the test results of the evaluated kit and the reference kit when detecting the samples of HIV infectors without HARRT. Conclusions High qualitative consistency and strong correlation between the evaluated kit and the refer- ence kit were found, as well as strong quantitative consistency of the test results of samples from the HIV infectors.