OraSure Technologies, Inc., 220 East First Street, Bethlehem, PA 18015, USA.
J Virol Methods. 2011 Mar;172(1-2):27-31. doi: 10.1016/j.jviromet.2010.12.009. Epub 2010 Dec 21.
The availability of a highly accurate, rapid, point-of-care test for hepatitis C virus (HCV) may be useful in addressing the problem of under-diagnosis of HCV, by increasing opportunities for testing outside of traditional clinical settings. A new HCV rapid test device (OraQuick® HCV Rapid Antibody Test), approved recently in Europe for use with venous blood, fingerstick blood, serum, plasma, or oral fluid was evaluated in a multi-center study and performance compared to established laboratory-based tests for detection of HCV. The HCV rapid test was evaluated in prospective testing of subjects with signs and/or symptoms of hepatitis, or who were at risk for hepatitis C using all 5 specimen types. Performance was assessed relative to HCV serostatus established by laboratory methods (EIA, RIBA and PCR) approved in Europe for diagnosis of hepatitis C infection. Sensitivity to antibody in early infection was also compared to EIA in 27 seroconversion panels. In addition, the reliability of the oral fluid sample for accurate detection of anti-HCV was assessed by studying the impact of various potentially interfering conditions of oral health, use of oral care products and consumption of food and drink. In this large study of at-risk and symptomatic persons, the overall specificities of the OraQuick® HCV Rapid Antibody Test were equivalent (99.6-99.9%) for all 5 specimen types and the 95% CIs substantially overlapped. Overall sensitivities were virtually identical for venous blood, fingerstick blood, serum and plasma (99.7-99.9%). Observed sensitivity was slightly lower for oral fluid at 98.1% though the upper CI (99.0%) was equal to the lower CI for venous blood and fingerstick blood. Most of the HCV positive subjects which gave nonreactive results in oral fluid had serological and virological results consistent with resolved infection. Sensitivity for anti-HCV in early seroconversion was virtually identical between the HCV rapid test and EIA. Detection of anti-HCV in oral fluid appeared generally robust to conditions of oral health, consumption of food and drink and use of oral care products. The OraQuick® HCV Rapid Antibody Test demonstrated clinical performance that was equivalent to current laboratory-based EIA. This new, HCV rapid test appears suitable as an aid in the diagnosis of HCV infection and may increase testing opportunities due to its simplicity and flexibility to use multiple specimen types, including fingerstick blood and oral fluid.
一种高度准确、快速的丙型肝炎病毒（HCV）即时检测方法的出现，可能有助于解决 HCV 诊断不足的问题，因为它增加了在传统临床环境之外进行检测的机会。一种新的 HCV 快速检测设备（OraQuick HCV 快速抗体检测）最近在欧洲获得批准，可用于静脉血、指血、血清、血浆或唾液，在一项多中心研究中对其进行了评估，并与用于检测 HCV 的既定实验室检测方法进行了比较。使用所有 5 种标本类型，对有肝炎症状和/或体征的患者或有感染丙型肝炎风险的患者进行了 HCV 快速检测的前瞻性检测。采用经欧洲批准用于诊断 HCV 感染的实验室方法（EIA、RIBA 和 PCR）确定的 HCV 血清状态来评估检测性能。还将其在 27 个血清转换组中检测早期感染抗体的敏感性与 EIA 进行了比较。此外，通过研究口腔健康的各种潜在干扰条件、口腔护理产品的使用以及食物和饮料的摄入对准确检测抗-HCV 的影响，评估了唾液样本的可靠性。在这项对高危人群和有症状人群的大型研究中，OraQuick HCV 快速抗体检测对所有 5 种标本类型的总体特异性（99.6%-99.9%）相当，95%CI 几乎重叠。静脉血、指血、血清和血浆的总体敏感性几乎相同（99.7%-99.9%）。唾液的观察敏感性略低，为 98.1%，但上限 CI（99.0%）与静脉血和指血的下限 CI 相等。大多数在唾液中检测结果为阴性的 HCV 阳性患者的血清学和病毒学结果与已解决的感染一致。在早期血清转换中，HCV 快速检测和 EIA 的抗-HCV 敏感性几乎相同。在口腔健康、食物和饮料摄入以及口腔护理产品使用的情况下，检测唾液中的抗-HCV 似乎普遍稳健。OraQuick HCV 快速抗体检测的临床性能与当前基于实验室的 EIA 相当。这种新的 HCV 快速检测似乎适合作为 HCV 感染诊断的辅助手段，由于其简单易用性和对多种标本类型（包括指血和唾液）的灵活性，可能会增加检测机会。
