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首页> 外文期刊>BMC Infectious Diseases >Diagnostic accuracy of tests to detect hepatitis B surface antigen: a systematic review of the literature and meta-analysis
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Diagnostic accuracy of tests to detect hepatitis B surface antigen: a systematic review of the literature and meta-analysis

机译：检测乙型肝炎表面抗原的检测方法的诊断准确性：文献和荟萃分析的系统综述

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Chronic Hepatitis B Virus (HBV) infection is characterised by the persistence of hepatitis B surface antigen (HBsAg). Expanding HBV diagnosis and treatment programmes into low resource settings will require high quality but inexpensive rapid diagnostic tests (RDTs) in addition to laboratory-based enzyme immunoassays (EIAs) to detect HBsAg. The purpose of this review is to assess the clinical accuracy of available diagnostic tests to detect HBsAg to inform recommendations on testing strategies in 2017 WHO hepatitis testing guidelines. The systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines using 9 databases. Two reviewers independently extracted data according to a pre-specified plan and evaluated study quality. Meta-analysis was performed. HBsAg diagnostic accuracy of rapid diagnostic tests (RDTs) was compared to enzyme immunoassay (EIA) and nucleic-acid test (NAT) reference standards. Subanalyses were performed to determine accuracy among brands, HIV-status and specimen type. Of the 40 studies that met the inclusion criteria, 33 compared RDTs and/or EIAs against EIAs and 7 against NATs as reference standards. Thirty studies assessed diagnostic accuracy of 33 brands of RDTs in 23,716 individuals from 23 countries using EIA as the reference standard. The pooled sensitivity and specificity were 90.0% (95% CI: 89.1, 90.8) and 99.5% (95% CI: 99.4, 99.5) respectively, but accuracy varied widely among brands. Accuracy did not differ significantly whether serum, plasma, venous or capillary whole blood was used. Pooled sensitivity of RDTs in 5 studies of HIV-positive persons was lower at 72.3% (95% CI: 67.9, 76.4) compared to that in HIV-negative persons, but specificity remained high. Five studies evaluated 8 EIAs against a chemiluminescence immunoassay reference standard with a pooled sensitivity and specificity of 88.9% (95% CI: 87.0, 90.6) and 98.4% (95% CI: 97.8, 98.8), respectively. Accuracy of both RDTs and EIAs using a NAT reference were generally lower, especially amongst HIV-positive cohorts. HBsAg RDTs have good sensitivity and excellent specificity compared to laboratory immunoassays as a reference standard. Sensitivity of HBsAg RDTs may be lower in HIV infected individuals.
机译：慢性乙型肝炎病毒（HBV）感染的特征在于持续存在的乙型肝炎表面抗原（HBsAg）。将HBV诊断和治疗计划扩展到资源不足的环境中，除了需要基于实验室的酶免疫测定（EIA）来检测HBsAg之外，还需要高质量但价格便宜的快速诊断测试（RDT）。这篇综述的目的是评估可用于检测HBsAg的诊断测试的临床准确性，以为2017年WHO肝炎测试指南中的测试策略提供建议。根据系统评价和荟萃分析的首选报告项目（PRISMA）指南，使用9个数据库进行了系统评价。两名审稿人根据预定计划独立提取数据并评估研究质量。进行荟萃分析。将快速诊断测试（RDT）的HBsAg诊断准确性与酶免疫测定（EIA）和核酸测试（NAT）参考标准进行了比较。进行了子分析，以确定品牌，艾滋病毒状况和样本类型之间的准确性。在符合纳入标准的40项研究中，有33项将RDT和/或EIA与EIA进行了比较，将7项与NAT进行了比较作为参考标准。三十项研究使用EIA作为参考标准，评估了来自23个国家/地区的23,716个人中33个RDT品牌的诊断准确性。合并的敏感性和特异性分别为90.0％（95％CI：89.1、90.8）和99.5％（95％CI：99.4、99.5），但不同品牌的准确性差异很大。无论使用血清，血浆，静脉或毛细管全血，准确性均无显着差异。与HIV阴性人群相比，在5例HIV阳性人群的研究中，RDT的合并敏感性较低，为72.3％（95％CI：67.9，76.4），但特异性仍然很高。五项研究针对化学发光免疫分析参考标准评估了8种EIA，其综合敏感性和特异性分别为88.9％（95％CI：87.0，90.6）和98.4％（95％CI：97.8，98.8）。使用NAT参考的RDT和EIA的准确性通常较低，尤其是在HIV阳性人群中。与作为参考标准的实验室免疫测定法相比，HBsAg RDT具有良好的敏感性和出色的特异性。 HIV感染者对HBsAg RDTs的敏感性可能较低。

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