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目的对某种人类免疫缺陷病毒Ⅰ型(HIV-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、R2和Bland-Altman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=0.853 6)。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。
Objective To evaluate the clinical application of a human immunodeficiency virus type 1 (HIV-1) nucleic acid quantitative detection kit (PCR-fluorescence probe method). Methods A total of 109 blood samples were collected from people with different HIV status. A parallel comparison test was carried out using the nucleic acid quantitative detection kit of HIV-1 evaluated reagent and reference reagent respectively. Statistical analysis used Kappa values, R2 and Bland-Altman models. Results The overall coincidence rate of the tested reagents was 97.25% (95% CI: 92.17% -99.43%) and Kappa was 0.92 (P <0.001). The consistency of the two reagents was the strongest. Among the 109 samples, 84 samples were detected within the quantitative range of the reagent and the reference reagent, and the regression analysis of the two reagents showed a strong correlation (R2 = 0.853 6). The Bland-Altman model was used to compare the means of differences between the two reagents and the results showed that the results of the two reagents in the HIV-infected patients without antiviral therapy showed good agreement. Conclusion The tested reagents and reference reagents have good qualitative consistency and strong correlation with the test results of the same plasma sample, and have strong quantitative consistency with the two reagent samples of HIV infected patients.