Liver Center, Sukhbaatar District, Ulaanbaatar, Mongolia.
Onom Foundation, Khan-Uul District, Ulaanbaatar, Mongolia.
PLoS One. 2020 Jul 15;15(7):e0235036. doi: 10.1371/journal.pone.0235036. eCollection 2020.
Early diagnosis of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is pivotal for optimal disease management. Sensitivity and specificity of 19 rapid diagnostic test (RDT) kits by different manufacturers (ABON, CTK Biotech, Cypress Diagnostics, Green Gross, Human Diagnostic, Humasis, InTec, OraSure, SD Bioline, Wondfo) were assessed on serum samples of 270 Mongolians (90 seropositive for hepatitis B surface antigen (HBsAg), 90 seropositive for hepatitis C antibody (HCV-Ab), 90 healthy subjects). All tested RDTs for detection of HBsAg performed with average sensitivities and specificities of 100% and 99%, respectively. Albeit, overall sensitivity and specificity of RDTs for detection of HCV-Ab was somewhat lower compared to that of HBsAg RDTs (average sensitivity 98.9%, average specificity 96.7%). Specificity of RDTs for detection of HCV-Ab was dramatically lower among HBsAg positive individuals, who were 10.2 times more likely to show false positive test results. The results of our prospective study demonstrate that inexpensive, easy to handle RDTs are a promising tool in effective HBV- and HCV-screening especially in resource-limited settings.
早期诊断慢性乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）感染对于优化疾病管理至关重要。我们评估了来自 270 名蒙古人的血清样本，这些人中有 90 人乙型肝炎表面抗原（HBsAg）血清阳性，90 人丙型肝炎抗体（HCV-Ab）血清阳性，90 人健康对照，评估了不同制造商（ABON、CTK Biotech、Cypress Diagnostics、Green Gross、Human Diagnostic、Humasis、InTec、OraSure、SD Bioline、Wondfo）的 19 种快速诊断检测试剂盒（RDT）的敏感性和特异性。所有用于检测 HBsAg 的 RDT 检测方法的平均敏感性和特异性均为 100%和 99%。然而，用于检测 HCV-Ab 的 RDT 的总体敏感性和特异性与 HBsAg RDT 相比略低（平均敏感性 98.9%，平均特异性 96.7%）。在 HBsAg 阳性个体中，用于检测 HCV-Ab 的 RDT 的特异性明显较低，这些个体发生假阳性检测结果的可能性要高出 10.2 倍。我们的前瞻性研究结果表明，价格低廉、易于操作的 RDT 是一种很有前途的乙型肝炎病毒和丙型肝炎病毒有效筛查工具，特别是在资源有限的环境中。
