Exacto® Triplex 快速检测试剂诊断 HIV/HCV/HBsAg 的诊断性能：中非共和国的一项多中心、横断面、现场研究。
Diagnostic performances of Exacto® Triplex rapid test for diagnosis of HIV/HCV/HBsAg: a multicenter, cross-sectional, field study in the Central African Republic.
机构信息
Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, République Centrafricaine.
Faculté des Sciences de la Santé, Université de Bangui, Bangui, République Centrafricaine.
出版信息
Pan Afr Med J. 2022 Sep 14;43:21. doi: 10.11604/pamj.2022.43.21.36041. eCollection 2022.
INTRODUCTION
the Exacto® Triplex HIV/HCV/HBsAg (Biosynex, Strasbourg, France) consists in lateral flow, immunochromatographic rapid diagnostic test simultaneously detecting human immunodeficiency virus (HIV)-1 and HIV-2 and hepatitis C virus (HCV)- specific antibodies (IgG and IgM) and hepatitis B virus (HBV) surface antigen (HBsAg) in serum, plasma and whole blood. We herein evaluated its diagnostic performances in the Central African Republic (CAR).
METHODS
cross-sectional study was conducted on prospectively collected panel of 550 sera from adult inpatients living in Bangui, including 200 HIV-positive, 100 HBsAg-positive, 50 HCV-positive, 200 negatives to three viruses according to reference immuno-enzymatic serological tests including Murex HCV (Diasorin, Saluggia, Italy) for HCV, Murex HBsAg (Diasorin) for HBV, Genscreen ULTRA HIV Ag-Ab HIV-1/2 Version 2 (Bio-Rad, Marnes-la-Coquette, France) and Murex HIV 1.2.0 Ag/Ab Combination (Diasorin), the 2 tests associated in the parallel algorithm for the reference strategy for the diagnosis of HIV in CAR. Serum samples were tested blindly in duplicate. The findings are reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
RESULTS
the Exacto® Triplex showed 99.5% (95% CI; 98.5-100.0), 96.0% [90.6-100.0] and 99.0% [97.1-100.0] sensitivities for HIV, HCV and HBsAg, respectively. The specificity, positive and negative predictive values (PPV and NPV) were 100.0% for all three viruses. The Youden's J index and Cohen's κ coefficient were 0.99 for HIV and HBsAg. For HCV, Youden's J and Cohen's κ coefficient were 0.96 and 0.98, respectively. In the epidemiological context of the CAR, the PPV and NPV for all three viral infections were high (≥99.0% to 100%).
CONCLUSION
taken together, our STROBE-compliant study demonstrates that the Exacto® Triplex HIV/HCV/HBsAg showed high sensitivity and specificity for HIV and HBsAg (≥99.0%), and relatively high sensitivity (96.0%) and high specificity (100%) for HCV. These analytical performances are within the limits required by the WHO (i.e. sensitivity ≥99.0% and specificity ≥98.0%) for HIV and HBV. The Exacto® Triplex HIV/HCV/HBsAg is user-friendly at low cost, and appears highly desirable for routine use in the CAR, and likely other Central African countries.
简介
Exacto® Triplex HIV/HCV/HBsAg（Biosynex，斯特拉斯堡，法国）是一种侧向流动免疫层析快速诊断测试，可同时检测血清、血浆和全血中的人类免疫缺陷病毒（HIV）-1 和 HIV-2 以及丙型肝炎病毒（HCV）特异性抗体（IgG 和 IgM）和乙型肝炎病毒（HBV）表面抗原（HBsAg）。本文评估了其在中非共和国（CAR）的诊断性能。
方法
对前瞻性收集的 550 例成年住院患者的血清进行了横断面研究，这些患者来自班吉，包括 200 例 HIV 阳性、100 例 HBsAg 阳性、50 例 HCV 阳性、200 例三种病毒阴性，根据参考免疫酶血清学检测，包括 Murex HCV（Diasorin，Saluggia，意大利）用于 HCV、Murex HBsAg（Diasorin）用于 HBV、Genscreen ULTRA HIV Ag-Ab HIV-1/2 Version 2（Bio-Rad，Marnes-la-Coquette，法国）和 Murex HIV 1.2.0 Ag/Ab 组合（Diasorin），该组合用于平行算法是用于诊断 CAR 中 HIV 的参考策略。血清样本以盲法重复检测。研究结果按照《观察性研究的报告的质量评估工具》（STROBE）指南进行报告。
结果
Exacto® Triplex 对 HIV、HCV 和 HBsAg 的灵敏度分别为 99.5%（95%CI；98.5-100.0）、96.0%[90.6-100.0]和 99.0%[97.1-100.0]。三种病毒的特异性、阳性和阴性预测值（PPV 和 NPV）均为 100.0%。HIV 和 HBsAg 的 Youden's J 指数和 Cohen's κ 系数分别为 0.99。对于 HCV，Youden's J 和 Cohen's κ 系数分别为 0.96 和 0.98。在 CAR 的流行病学背景下，三种病毒感染的 PPV 和 NPV 均较高（≥99.0%至 100%）。
结论
综上所述，我们符合 STROBE 标准的研究表明，Exacto® Triplex HIV/HCV/HBsAg 对 HIV 和 HBsAg 的灵敏度和特异性均较高（≥99.0%），对 HCV 的灵敏度较高（96.0%）和特异性较高（100%）。这些分析性能符合世界卫生组织（WHO）的要求（即灵敏度≥99.0%和特异性≥98.0%），适用于 HIV 和 HBV。Exacto® Triplex HIV/HCV/HBsAg 使用方便，成本低廉，非常适合在 CAR 以及可能在其他中非国家常规使用。
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