Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain; CIBERehd, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Instituto de Salud Carlos III, Madrid, Spain.
Liver Transplantation and Hepatology Laboratory, Instituto Investigación Sanitaria La Fe, Valencia, Spain.
J Clin Virol. 2018 May;102:77-83. doi: 10.1016/j.jcv.2018.02.016. Epub 2018 Feb 24.
A reliable population screening strategy for hepatitis C virus (HCV) infection may be based in easy-to-use point-of-care (POC) tests for HCV antibodies, but validation data is needed before their potential widespread use in primary care or outreach practice. Besides, the sensitivity of these POC tests in patients with spontaneous or treatment-induced viral clearance is unknown.
To test the performance of a non-invasive POC anti-HCV test (OraQuick HCV rapid test) in oral mucosal transudate (OMT) and fingerstick blood from patients with known anti-HCV serostatus and with or without active viremia (after treatment-induced clearance).
A risk factor questionnaire was collected from 317 consecutive patients (anti-HCV positive/HCV-RNA positive n = 107; anti-HCV positive/HCV-RNA negative after antiviral treatment n = 107; anti-HCV negative with other liver diseases n = 109) before performing the OraQuick HCV rapid test in OMT (n = 317) and fingerstick blood (n = 251). We calculated the sensitivity and specificity of the test by using anti-HCV serostatus as the reference gold-standard.
Among all anti-HCV seropositive patients, the clinical sensitivity and specificity of the OraQuick HCV rapid test in OMT was 89.9% and 100%, respectively. In fingerstick blood, the sensitivity improved to 98.8%. The sensitivity was higher in OMT (97.2%) in anti-HCV seropositive patients who were viremic as compared to that in non-viremic individuals (82.2%). In contrast, there were no significant differences in sensitivity between viremic and non-viremic individuals when testing fingerstick blood. Finally, extension of the read time to 40 min enhanced the sensitivity, especially in OMT (up to 94.7%) and in the subgroup of non-viremic, anti-HCV-positive patients (up to 90.1%).
The OraQuick HCV rapid test in OMT has a high sensitivity and specificity for detecting active HCV infection that decreases substantially in anti-HCV positive/HCV-RNA negative patients with treatment-induced viral clearance. For these individuals, extension of read times and testing fingerstick blood showed improved sensitivity.
针对丙型肝炎病毒（HCV）感染，可靠的人群筛查策略可能基于 HCV 抗体的即用型床边（POC）检测，但在这些检测于初级保健或外展实践中广泛应用之前，需要验证其数据。此外，这些 POC 检测在自发性或治疗诱导的病毒清除患者中的敏感性尚不清楚。
检测一种非侵入性 POC 抗 HCV 检测（OraQuick HCV 快速检测）在口腔黏膜渗出液（OMT）和指血样本中的性能，这些样本来自已知抗 HCV 血清学状态的患者，且具有或不具有活动性病毒血症（治疗诱导清除后）。
对 317 例连续患者（抗 HCV 阳性/HCV-RNA 阳性 n=107；抗 HCV 阳性/治疗后 HCV-RNA 阴性 n=107；抗 HCV 阴性伴其他肝病 n=109）进行问卷调查，然后分别在 OMT（n=317）和指血样本（n=251）中进行 OraQuick HCV 快速检测。我们以抗 HCV 血清学状态为参考金标准，计算检测的敏感性和特异性。
在所有抗 HCV 阳性患者中，OraQuick HCV 快速检测在 OMT 中的临床敏感性和特异性分别为 89.9%和 100%。在指血样本中，敏感性提高至 98.8%。与非病毒血症患者相比，病毒血症患者（97.2%）的 OMT 检测敏感性更高。相反，在检测指血样本时，病毒血症和非病毒血症患者之间的敏感性无显著差异。最后，将读片时间延长至 40 分钟可提高敏感性，尤其是在 OMT（提高至 94.7%）和非病毒血症、抗 HCV 阳性患者的亚组中（提高至 90.1%）。
OraQuick HCV 快速检测在 OMT 中检测 HCV 活性感染的敏感性和特异性均较高，但在治疗诱导病毒清除后的抗 HCV 阳性/HCV-RNA 阴性患者中显著降低。对于这些患者，延长读片时间和检测指血样本可提高敏感性。
