一种国产人类免疫缺陷病毒I型病毒载量检测试剂的临床应用性能评估

Clinical evaluation of a domestic reagent for detecting HIV-1 virus load

目的评价一种国产人类免疫缺陷病毒I型(HIV-1)病毒载量试剂的临床应用性能。方法选取250例艾滋病病毒感染者/病人的血浆样本,分别使用国产待测试剂和参比试剂进行双盲试验,对试验结果开展定性及定量统计学分析;采用阴阳性符合率及Kappa检验定性分析一致性;采用相关性、回归分析和Bland-Altman模型等统计方法定量分析一致性。结果参比试验阴阳性符合率为100%,Kappa值为1(P<0.001),Pearson相关系数为0.965(P<0.001),回归分析R2=0.931,Bland-Altman模型中96%的检测结果位于95%的置信区间内,100%的检测结果位于99%的置信区间内,说明两种试剂检测结果具有高度一致性。结论对于同一临床样本检测结果,待测试剂与参比试剂具有较高的定性符合率,高度的定量一致性表明待测试剂与参比试剂检测结果表现出较强的相关性。

Objective To evaluate clinical application performance of a domestic human immunodeficiency virus type1(HIV-1)viral load reagent.Methods Two hundred and fifty blood samples were collected,and the relationship between the two reagents was analyzed by simultaneous detection of HIV quantitative nucleic acid kits,which from Roche Company and Northeast Pharmaceutical Group.The consistency of the two reagents was analyzed by Kappa test.The correlation between the two reagents was analyzed by correlation analysis,regression analysis and Bland-Altman.Results Coincidence rate of positive and negative was 100%,with Kappa test value of 1(P<0.001)and Pearson’s coefficient correlation of 0.965(P<0.001).The regression analysis results was 0.931.Bland-Altman showed that 96%of the results were within the 95%confidence intervals,and 100%within 99%.It suggested that there was high consistency of the results between the two reagents.Conclusions There is high qualitation coincidence of the results of the same clinical sample between the two reagents.And high quantitate concordance shows the strong correlation between the two reagents.