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(P<0.001)。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。
Objective To evaluate the variation and stability（perormance） of a new domestic human immunodeficiency virus type KHIV-1） quantitative nucleic acid detection kit.Methods Blood samples from 200 HIV-1 clinical patients were collected and blind detection was conducted by both the tested kit and the reference kit.Qualitative results were assessed by the positive and negative coincidence rate and Kappa statistics.Viral load results were compared by correlation,regression analysis and Bland-Altman plot.Results The two assays yielded a correlation rate of 100%,and Kappa value was 1（P〈0.001）.The results also represented very good correlation（R^2=0.933） by regression analysis.The comparison by Bland Altman model showed that of the two kinds of reagents,97.06%（165/170） samples were within the boundary of 95%consistency,explaining good consistency of the two reagents by the test results.The test results of the samples with antiretroviral treatment（ART） showed that the correlation of the two reagents was 0.968,and the strong correlation（R2=0.937） was reaffirmed by the regression analysis.Bland-Altman model showed that 96.64%of the samples was within the boundary of 95%consistency,implying good consistency of the two reagents for the samples receiving ART.Among the samples without ART,the correlation of two reagents in the test results reached 0.952,with the strong correlation（R2=0.906） confirmed by the regression analysis.Bland-Altman model showed 98.04%of the samples in 95%consistency.Conclusion It is found that the domestic reagent has strong correlation with the imported reagent,suggesting that the new detection kit is high quality.
作者
邹静波
Zou Jingbo.(Yongchuan District Center for Disease Control and Prevention, Chongqing 402160, China)
出处
《中国艾滋病性病》
CAS
CSCD
北大核心
2017年第2期94-97,共4页
Chinese Journal of Aids & STD
