Xpert HIV-1病毒载量检测系统用于HIV-1病毒载量检测的临床价值

Clinical value of Xpert HIV-1 virus load detection system for HIV-1 virus load assay

目的探讨Xpert HIV-1病毒载量(Xpert HIV-1 VL)检测用于HIV-1病毒载量检测的临床价值。方法采用Xpert HIV-1 VL和Abbott m2000 Real Time检测系统(Abbott m2000)同时检测191份血浆样本的HIV-1病毒载量。采用符合率、卡方检验和Kappa值等统计分析两种检测方法定性检测结果的一致性,采用相关性、回归分析和Bland-Altman模型等统计分析两种检测方法定量检测结果的一致性。结果两种检测方法的阳性符合率、阴性符合率和总符合率均为100%,两种方法检测结果一致性分析的Kappa值为1.00(P<0.001);两种方法检测结果的相关系数为0.9576,回归分析表现出较高的相关性(R2=0.9170),Bland-Altman模型分析显示两种方法检测有95.3%(164/172)的样本在95%一致性界限内。结论Xpert HIV-1 VL用于检测HIV-1 RNA具有很高的灵敏度、准确性和稳定性,且操作简单、方便、安全,适合临床用于对HIV-1患者血浆样本中HIV-1 RNA的检测。

Objective To examine the clinical value of Xpert HIV-1 viral load assay(Xpert HIV-1 VL)in detection of HIV-1 viral load.Methods HIV-1 viral load was detected simultaneously by Xpert HIV-1 VL and Abbott m2000 Real Time detecting system(Abbott m2000)in 191 plasma samples.Qualitative results were assessed by coincidence rate,Chi-square test,and Kappa value.Viral load were compared by correlation,regression analysis,and Bland-Altman model.Results The positive coincidence rate,negative coincidence rate,and total coincidence rate of the two methods were 100%.Kappa value of the two methods was 1.00(P<0.001).The results provided by the two methods were highly correlated(r=0.9576),which was confirmed by regression analysis(R2=0.9170).Bland-Altman model analysis showed the results were within 95%consistency limit for 95.3%(164/172)of the samples.Conclusions Xpert HIV-1 VL shows high sensitivity,accuracy and stability in detection of HIV-1 RNA.It is simple,convenient and safe.It is suitable for clinical detection of HIV-1 RNA in plasma samples of HIV-1 patients.