某国产HIV-1病毒载量检测试剂盒的临床应用性能评估

发布时间：2018-04-09 16:08

本文选题：艾滋病病毒型　切入点：病毒载量　出处：《中国艾滋病性病》2017年02期

【摘要】：目的对某国产艾滋病病毒1型(HIV-1)病毒载量检测试剂盒的应用性能进行评估。方法收集200份血液样品,分别用该国产待评估试剂(简称待测试剂)与进口参比试剂(简称参比试剂)进行盲试检测。然后采用阴阳性符合率和卡方检验等统计方法,来判定两种试剂定性检测结果的一致性;用相关性、回归分析和Bland-Altman模型等统计方法,来判定两种试剂定量检测结果的一致性。结果两种试剂总体符合率达100%,Kappa值为1.000(P0.001)。两种试剂盒检测结果的回归分析表现出较强的相关性(R~2=0.933)。运用Bland-Altman模型比对,显示两种试剂检测结果有97.06%(165/170)的样本在95%一致性界限内,说明两种试剂检测结果的一致性较好。文章还将经治疗样本和未经治疗样本的检测结果进行定量检测结果分析,结果显示,治疗样本两种试剂检测结果的相关性为0.968,回归分析表现出强相关性(R~2=0.937);Bland-Altman模型显示,有96.64%的样本在95%一致性界限内,说明两种试剂在治疗样本中的一致性较好。在未治疗样本中,两种试剂检测结果的相关性为0.952,回归分析表现出强相关性(R~2=0.906);Bland-Altman模型显示,有98.04%的样本在95%一致性界限内,说明两种试剂在未治疗样本中的一致性较好。从经过治疗样本和未经治疗样本的定量检测结果可以看出,无论是否接受治疗,国产试剂与进口试剂在检测在检样本的测试效果方面具有强相关性。结论该国产试剂和进口试剂检测结果具有较高的定性符合率、较强的相关性以及较强的定量一致性。
[Abstract]:Objective to evaluate the performance of a domestic HIV-1 carrier kit.Methods 200 blood samples were collected for blind test with the domestic and imported reference reagents.Then we use statistical methods such as yin-yang coincidence rate and chi-square test to determine the consistency of the qualitative test results of the two reagents, and use statistical methods such as correlation, regression analysis and Bland-Altman model to determine the consistency of the quantitative test results of the two reagents.Results the overall coincidence rate of the two reagents was 100% and the Kappa value was 1.000 kappa (P 0.001).The regression analysis of the results of the two kits showed a strong correlation.The Bland-Altman model was used to compare the results of the two reagents. The results showed that the results of the two reagents were within the 95% consistency limit, which indicated that the results of the two reagents were in good agreement.The results of quantitative analysis of the results of the two reagents were also analyzed. The results showed that the correlation between the results of the two reagents was 0.968, and the regression analysis showed that the Bland-Altman model showed a strong correlation between the two reagents, and the Bland-Altman model showed that there was a strong correlation between the two reagents.96.64% of the samples were within the 95% consistency limit, indicating that the two reagents had good consistency in the treatment samples.Among the untreated samples, the correlation between the results of the two reagents was 0.952. The regression analysis showed that there was a strong correlation between the two reagents. The Bland-Altman model showed that 98.04% of the samples were within the 95% consistency limit, which indicated that the consistency of the two reagents in the untreated samples was better.It can be seen from the quantitative test results of treatment samples and untreated samples that domestic reagents and imported reagents have strong correlation in the testing effect of samples whether or not they are treated.Conclusion the detection results of domestic and imported reagents have high qualitative coincidence rate, strong correlation and strong quantitative consistency.
【作者单位】：重庆市永川区疾病预防控制中心;
【分类号】：R512.91

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