Xpert HIV-1病毒载量检测试剂盒的检测线性和精密度评估  

Evaluation of detection linearity and precision of the Xpert HIV-1 Viral Load test kits

作　　者：张信辉[1] 万永虎[1] 吴萍 王寅寅[1] Zhang Xinhui;Wan Yonghu;Wu Ping;Wang Yinyin(Guizhou Provincial Center for Disease Control and Prevention,Guiyang 550004,Guizhou,China)

机构地区：[1]贵州省疾病预防控制中心,贵州贵阳550004

出　　处：《贵州医药》2024年第12期1860-1862,F0003,共4页Guizhou Medical Journal

基　　金：贵州省卫生健康委科学技术基金项目(gzwkj2022-211)。

摘　　要：目的 评价1型艾滋病病毒(HIV-1),Xpert病毒载量测定试剂盒的检测线性、精密度及与参比试剂的符合性。方法 采用定值质控物对Xpert病毒载量进行测定,并对其进行线性及精密度测定。采集血样383份,采用双盲试验法,以TaqMan病毒载量测定试剂进行检验。依据多项卫生推荐标准(WS/T),利用卡方检验和Kappa检验法对两种试剂进行定性检验;采用多元回归、Bland-Altman模型等统计学方法对两种试剂进行一致性比较。结果 用Xpert病毒载量测定试剂对给定的质控物有很好的线性关系,批内和批间的方差都在10%以内。用1 000个copies/mL和5 000个copies/mL作为检测线,两种方法的一致性分别为97.91%、97.12%。卡方检定和Kappa分别为P=0.549(>0.05)和0.919(P<0.001),表明两者的诊断具有良好的一致性。两种方法的测定值之间的相关性为0.890,相关系数R^(2)=0.896。通过Bland-Altman模型比较,发现两种试剂的检出值均在95%上下限范围内的符合率为98.79%(327/331)。在1 000 copies/mL以下,病毒载量的相关性相对较低。结论 评价试剂(Xpert)与参比试剂(TaqMan)在整体上具有很好的一致性,可以满足大部分的临床检验需要。Objective To Evaluate the detection linearity,precision and conformity of the Xpert viral load test kit for HIV type 1(HIV-1).Methods Using fixed value quality control substances to measure the Xpert virus load,and conducting linear and precision measurements.The total of 383 blood samples were collected and tested with TaqMan viral load measurement reagent by double-blind test.Based on multiple health recommendations(WS/T),Chi-square test and Kappa test were used to test the two reagents qualitatively.Statistical methods such as multiple regression and Bland-Altman model were used to compare the consistency of the two reagents.Results Xpert virus load assay reagent had a good linear relationship with the given quality control substance,and the variance within and between batches was within 10%.With 1000 copies/mL and 5000 copies/mL as detection lines,the consistency of the two methods was 97.91%and 97.12%,respectively.The Chi-square test showed P=0.549(>0.05),and the Kappa value was 0.919(P<0.001),and indicated good diagnostic agreement between the two methods.The correlation between the test results of the two reagents was 0.890,and the correlation coefficient of regression equation was R^(2)=0.896.Bland-Altman model comparison was shown that 98.79%(327/331)of the samples of the two reagents fell between 95%upper and lower limits of the test consistency.The viral load interval below 1000 copies/mL correlation was slightly lower.Conclusion The evaluation reagent(Xpert)and reference reagent(TaqMan)have good overall consistency and can meet most clinical testing needs.

关 键 词：1型艾滋病病毒 病毒载量检测 性能评估 

分 类 号：R512.91[医药卫生—内科学]