在马里巴马科对Xpert HIV-1病毒载量检测法与罗氏Taqman及雅培M2000 RT的性能比较
Performance Comparison of Xpert HIV-1 Viral Load Assay and Roche Taqman and Abbott M2000 RT in Bamako, Mali.
作者信息
Kone Bourahima, Goita Drissa, Dolo Oumar, Traore Daouda, Sogoba Dramane, Somboro Amadou, Sanogo Moumine, Somboro Anou M, Coulibaly Nadie, Sanogo Alou, Diarra Zoumana, Traore Madou, Maiga Almoustapha I, Baya Bocar, Sarro Yeya Dit Sadio, Diarra Bassirou, Kone Amadou, Diallo Dramane, Dabitao Djeneba, Holl Jane L, Belson Michael, Dao Sounkalo, Murphy Robert L, Diakite Mahamadou, Diallo Souleymane, Doumbia Seydou, Maiga Mamoudou
机构信息
University Clinical Research Center (UCRC)-SEREFO, University of Sciences, Techniques and Technologies of Bamako (USTTB), Bamako, Mali.
Sikasso, Regional Hospital, Mali.
出版信息
J AIDS Clin Res. 2020;11(7). Epub 2020 Jul 30.
BACKGROUND
Routine monitoring of HIV-1 Viral Load (VL) is important in patients on Antiretroviral Therapy (ART) management. Access to HIV VL remains a challenge in resource-limited settings, especially in rural areas. Universal access to VL requires more simplified and less restrictive alternatives to current conventional VL methods. The objective of this study was to evaluate the performance of the new rapid (2-hour turnaround time) Xpert HIV-1VL technique compared to Roche TaqMan and Abbott RT m2000 for HIV-1 RNA quantification in HIV- infected patients.
STUDY DESIGN
We conducted a cross-sectional study in patients seen for routine VL monitoring between August and November 2018 in a HIV care site in Bamako. The performance of the Xpert HIV-1 VL assay was evaluated against the Roche TaqMan assay and Abbott m2000 RT assay. Performance, utility and reliability/reproducibility were verified using accuracy, sensitivity, specificity, positive and negative predictive values, Diagnostic Odds Ratio (DOR), Kappa coefficient, Pearson correlation coefficient, and Bland-Altman analysis.
RESULTS
The Xpert assay compared well with the two current referral assays (Roche TaqMan and Abbott m2000 RT assays). Compared to Roche TaqMan assay the sensitivity was 93.10%, specificity (97.01%) and accuracy (95.20%), the correlation coefficient of Pearson (r) was 0.98 (p <0.01). Bland-Altman analysis showed a mean difference of 0.18 log10 cp/mL; (Standard Deviation) SD=0.33. Compared to the Abbott m2000 RT, the sensitivity, the specificity and the accuracy were respectively 93.44%; 92% and 92.65%. The Xpert HIV-1 VL assay showed a good correlation with a correlation coefficient of Pearson, r=0.99 (p <0.001). The overall mean difference in the HIV-1 VL values obtained by Xpert HIV-1 VL and Abbott m2000 RT assays was 0.08 log10 cp/mL; SD=0.30.
CONCLUSION
Xpert HIV-1 VL showed a good performance compared to Roche TaqMan and Abbott m2000 RT. With the rapid test results (less than 2 h) and ease of testing individual specimens, the Xpert HIV-1 VL assay could be an effective alternative for HIV VL monitoring in resource-limited settings.
背景
在接受抗逆转录病毒治疗（ART）管理的患者中，常规监测HIV-1病毒载量（VL）很重要。在资源有限的环境中，尤其是农村地区，获取HIV病毒载量检测仍面临挑战。要实现普遍的病毒载量检测，需要比当前传统病毒载量检测方法更简化、限制更少的替代方法。本研究的目的是评估新型快速（周转时间2小时）的Xpert HIV-1 VL技术与罗氏TaqMan和雅培RT m2000相比，在HIV感染患者中进行HIV-1 RNA定量检测的性能。
研究设计
我们于2018年8月至11月在巴马科的一个HIV护理点，对前来进行常规病毒载量监测的患者进行了一项横断面研究。针对罗氏TaqMan检测和雅培m2000 RT检测，评估了Xpert HIV-1 VL检测的性能。使用准确性、敏感性、特异性、阳性和阴性预测值、诊断比值比（DOR）、kappa系数、皮尔逊相关系数和布兰德-奥特曼分析来验证性能、实用性和可靠性/可重复性。
结果
Xpert检测与两种当前的参考检测（罗氏TaqMan和雅培m2000 RT检测）相比表现良好。与罗氏TaqMan检测相比，敏感性为93.10%，特异性为97.01%，准确性为95.20%，皮尔逊相关系数（r）为0.98（p<0.01）。布兰德-奥特曼分析显示平均差异为0.18 log10拷贝数/mL；（标准差）SD = 0.33。与雅培m2000 RT相比，敏感性、特异性和准确性分别为93.44%、92%和92.65%。Xpert HIV-1 VL检测显示出良好的相关性，皮尔逊相关系数r = 0.99（p<0.001）。Xpert HIV-1 VL检测和雅培m2000 RT检测获得的HIV-1病毒载量值的总体平均差异为0.08 log10拷贝数/mL；SD = 0.30。
结论
与罗氏TaqMan和雅培m2000 RT相比，Xpert HIV-1 VL表现良好。凭借快速的检测结果（不到2小时）以及单个样本检测的简便性，Xpert HIV-1 VL检测可能是资源有限环境中HIV病毒载量监测的有效替代方法。
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