Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
Laboratory of Tecnhological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
J Clin Virol. 2014 Jul;60(3):200-5. doi: 10.1016/j.jcv.2014.04.001. Epub 2014 Apr 13.
Rapid tests for the detection of antibodies to hepatitis C virus (anti-HCV) can facilitate access to diagnosis.
This study aimed to evaluate the performance of rapid tests for anti-HCV detection in the sera, whole blood, and oral fluid samples from individuals with different endemicity profiles and risk behaviors.
Three groups donated biological samples that were tested using three anti-HCV rapid tests (WAMA, Bioeasy and OraSure): (I) suspected cases of hepatitis C, (II) individuals who were living in remote areas in Brazil and (III) crack users and beauty professionals. Reproducibility, repeatability and cross-reactivity to other infectious agents (dengue, HIV, malaria, and syphilis) were also evaluated.
In group I, specificities varied from 93.75% to 100% and sensitivities varied from 76.03% to 93.84% according to the EIA results. When anti-HCV/HCV RNA-reactive sera samples were considered true-positive HCV cases, the sensitivities and specificities varied from 86.3% to 99.09% and 93.75% to 100%, respectively. In group II, the OraSure rapid test presented the best performance. In group III, the Bioeasy assay performed best using saliva and whole blood and the OraSure assay performed best using oral fluid samples. The reproducibility and repeatability of the WAMA and Bioeasy tests were excellent. The level of concordance between the HCV EIAs and the rapid tests using samples that were reactive for other infectious agents varied from 82.35% to 100% for the WAMA assay and 94.11% to 100% for the Bioeasy assay.
All of the rapid tests could be used to identify active HCV infection among individuals with different endemicity profiles and risk behaviors.
快速检测丙型肝炎病毒抗体（抗-HCV）可促进诊断。
本研究旨在评估不同流行程度和风险行为个体的血清、全血和口腔液样本中丙型肝炎病毒快速检测的性能。
三组捐献了生物样本，这些样本使用三种丙型肝炎病毒快速检测试剂盒（WAMA、Bioeasy 和 OraSure）进行检测：（I）丙型肝炎疑似病例；（II）巴西偏远地区的个体；（III） 可卡因使用者和美容专业人员。还评估了重复性、再现性和对其他传染性病原体（登革热、HIV、疟疾和梅毒）的交叉反应性。
在第 I 组中，根据 EIA 结果，特异性在 93.75%至 100%之间，敏感性在 76.03%至 93.84%之间变化。当将抗-HCV/HCV RNA 反应性血清样本视为真正的丙型肝炎阳性病例时，敏感性和特异性分别在 86.3%至 99.09%和 93.75%至 100%之间变化。在第 II 组中，OraSure 快速检测表现最佳。在第 III 组中，Bioeasy 检测法在唾液和全血中表现最佳，OraSure 检测法在口腔液样本中表现最佳。WAMA 和 Bioeasy 检测的重现性和再现性均极佳。使用对其他传染性病原体反应性的样本进行 HCV EIA 和快速检测之间的一致性水平在 WAMA 检测法中为 82.35%至 100%，在 Bioeasy 检测法中为 94.11%至 100%。
所有快速检测都可用于识别不同流行程度和风险行为个体中的活跃丙型肝炎病毒感染。
