Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.
Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study.
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DOI：
10.1093/infdis/jiaa389
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发表时间：
2022-08-26
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影响因子：
--
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丙型肝炎病毒（HCV）筛查对于消除HCV的努力至关重要。对于资源匮乏的环境和难以接触到的人群，需要简化诊断。本回顾性研究评估了快速诊断试验（RDTs）检测HCV抗体的性能。使用来自4个国家（尼日利亚、格鲁吉亚、柬埔寨和比利时）的存档血浆样本，在3个实验室评价了2个批次的13个RDT。根据复合算法，使用3种参考检测确定HCV状态。在HIV感染和未感染人群中评价了敏感性和特异性。还评估了业务特点。共有1710份样本符合入选标准。在HIV未感染样本（n = 384）中，大多数RDT在1个或2个批次中的灵敏度≥98%，大多数RDT的特异性≥ 99%。 在HIV感染的样本中（n = 264），特异性仍然很高，但灵敏度明显低于HIV未感染的样本;只有1个RDT达到> 95%。 大多数敏感性低的HIV感染样本没有可检测的HCV病毒载量/核心抗原。所有RDT的读数员间变异性、批间变异性和无效运行率均较低（<2%）。HCV RDT应在预期目标人群中进行评价，因为敏感性可能受到HIV状态等人群因素的影响。NCT 04033887在对13种丙型肝炎病毒抗体检测快速诊断检测试剂进行的性能评价中，未感染HIV的血浆样本的灵敏度和特异性均较高。在HIV感染的样本中，特异性仍然很高，但敏感性明显降低。
Hepatitis C virus (HCV) screening is critical to HCV elimination efforts. Simplified diagnostics are required for low-resource settings and difficult-to-reach populations. This retrospective study assessed performance of rapid diagnostic tests (RDTs) for detection of HCV antibodies. Two lots of 13 RDTs were evaluated at 3 laboratories using archived plasma samples from 4 countries (Nigeria, Georgia, Cambodia, and Belgium). HCV status was determined using 3 reference tests according to a composite algorithm. Sensitivity and specificity were evaluated in HIV-infected and HIV-uninfected populations. Operational characteristics were also assessed. In total, 1710 samples met inclusion criteria. In HIV-uninfected samples (n = 384), the majority of RDTs had sensitivity ≥98% in 1 or both lots and most RDTs had specificity ≥99%. In HIV-infected samples (n = 264), specificity remained high but sensitivity was markedly lower than in HIV-uninfected samples; only 1 RDT reached >95%. The majority of HIV-infected samples for which sensitivity was low did not have detectable HCV viral load/core antigen. Interreader variability, lot-to-lot variability, and rate of invalid runs were low for all RDTs (<2%). HCV RDTs should be evaluated in the intended target population, as sensitivity can be impacted by population factors such as HIV status. NCT04033887 In this performance evaluation of 13 rapid diagnostic tests for hepatitis C virus antibody detection, sensitivity and specificity were high in HIV-uninfected plasma samples. In HIV-infected samples, specificity remained high, but sensitivity was markedly reduced.
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影响因子：
34.3
作者：
Tordrup, David;Hutin, Yvan;Hirnschall, Gottfried
通讯作者：
Hirnschall, Gottfried
DOI：
10.5935/1676-2444.20140026
发表时间：
2014-08-01
影响因子：
--
作者：
Castejon, Marcia Jorge;Yamashiro, Rosemeire;Ueda, Mirthes
通讯作者：
Ueda, Mirthes
影响因子：
1.8
作者：
Fondjo, Clavel Landry Kouam;Ngoupo, Paul Alain Tagnouokam;Njouom, Richard
通讯作者：
Njouom, Richard
DOI：
10.1128/cdli.10.1.19-21.2003
发表时间：
2003-01-01
期刊：
CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY
影响因子：
--
作者：
Pinsky, NA;Huddleston, JM;Poland, GA
通讯作者：
Poland, GA
影响因子：
14.2
作者：
Chevaliez, S.;Poiteau, L.;Pawlotsky, J. -M.
通讯作者：
Pawlotsky, J. -M.