Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care
Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care
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DOI：
10.1016/j.cmi.2016.01.009
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发表时间：
2016-05-01
影响因子：
14.2
通讯作者：
Pawlotsky, J. -M.
中科院分区：
文献类型：
--
作者：
Chevaliez, S.;Poiteau, L.;Pawlotsky, J. -M.
需要进行大规模丙型肝炎筛查，以防止感染的进一步传播，在不含干扰素-α的新丙型肝炎病毒(HCV)药物方案的背景下改善获得护理的机会，并随后降低慢性肝病的长期并发症的风险。快速诊断试验(RDT)是使用静脉穿刺血进行酶免疫分析的一种有吸引力的替代方法。本研究的目的是前瞻性地评估CE标记的RDTs检测手指、毛细血管、全血和/或口腔液中的抗丙型肝炎病毒抗体的临床表现。共有513名患者进入前瞻性研究，包括318名慢性丙型肝炎病毒感染者、25名已缓解的丙型肝炎病毒感染者和170名丙型肝炎病毒血清阴性者。指纹全血RDTs的特异度为98.8%~100%。OraQuick(注册商标)和Toyo(注册商标)检测的临床敏感性较高(分别为99.4%和95.8%)，但Labmen(注册商标)检测的敏感性较低(63.1%)。OraQuick(R)试验的特异性和临床敏感性均令人满意(分别为100%和97.6%)。在病人护理的背景下，丙型肝炎病毒抗体RDTs容易和快速地执行。他们非常具体。OraQuick(注册商标)和Toyo(注册商标)测试都达到了大规模使用的预期性能水平，OraQuick(注册商标)丙型肝炎病毒测试具有性能优势。RDTS似乎是在高危到中危人群中大规模筛查丙型肝炎病毒感染的一种很有前途的新工具。因此，在临床应用之前，必须对丙型肝炎病毒RDTs的性能进行仔细的评估。(C)2016年欧洲临床微生物学和传染病学会。爱思唯尔有限公司出版。保留所有权利。
Large-scale hepatitis C screening is required to prevent further spread of the infection, improve access to care in the context of new hepatitis C virus (HCV) drug regimens without interferon-alpha and subsequently reduce the risk of long-term complications of chronic liver disease. Rapid diagnostic tests (RDTs) represent an attractive alternative to enzyme immunoassay using blood from venepuncture. The aim of the present study was to prospectively assess the clinical performance of CE-marked RDTs detecting anti-HCV antibodies in fingerstick capillary whole blood and/or oral fluid. A total of 513 individuals, including 318 patients with chronic HCV infection, 25 patients with resolved HCV infection and 170 HCV-seronegative individuals, were prospectively enrolled. The specificity of RDTs with fingerstick whole blood varied from 98.8% to 100%. The clinical sensitivity was high for the OraQuick (R) and Toyo (R) tests (99.4% and 95.8%, respectively), but low for the Labmen (R) test (63.1%). The specificity and clinical sensitivity in crevicular fluid were both satisfactory for the OraQuick (R) test (100% and 97.6%, respectively). HCV antibody RDTs were easy and rapid to perform in the context of patient care. They were highly specific. Both the OraQuick (R) and Toyo (R) tests reached the expected level of performance for wide-scale use, with a performance advantage for the OraQuick (R) HCV test. RDTs appear to be a promising new tool for wide-scale screening of HCV infection in high-risk to medium-risk populations. Hence, careful assessment of the performance of HCV RDTs must be recommended before they can be implemented in clinical practice. (C) 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.