Department of Hepatology, The First Hospital of Jilin University, Jilin University, Changchun, 130021, China.
Virol J. 2020 Jan 31;17(1):14. doi: 10.1186/s12985-020-1293-7.
Hepatitis C virus (HCV) infection is a public health issue for which an effective universal screening method is urgently needed. An oral anti-HCV test could provide a noninvasive and rapid screening strategy for HCV infection. This study evaluated the performance of a new point-of-care oral assay developed by Well for the detection of HCV antibody.
Individuals from three centers with and without HCV infection were enrolled. All participants were tested for oral HCV antibody using the Well assay and for serum HCV antibody using established tests (ARCHITECT i2000 anti-HCV assay and InTec serum anti-HCV assay). For participants who obtained positive results, HCV RNA was tested for verification. Some patients underwent the OraQuick HCV test at the same time, and some self-tested with the Well assay during the same period.
A total of 1179 participants, including 486 patients with chronic HCV infection, 108 patients with other liver diseases, and 585 individuals who underwent physical examination, were enrolled. The Well anti-HCV test had a sensitivity of 91.88% (95% confidence interval [CI]: 88.97-94.09%) and a specificity of 98.00% (96.58-98.86%) for oral HCV antibody detection. The consistency between the Well and InTec assays was 97.02% (1138/1179). The consistency between the Well and OraQuick assays was 98.50% (197/200). Furthermore, the results of self-testing were highly consistent with those of researcher-administered tests (Kappa = 0.979). In addition, the HCV RNA results also showed that HCV RNA could only be detected on 1 of the 39 false-negative samples, and for 172 positive HCV RNA results, 171 could be detected by the Well oral anti-HCV assay.
The Well oral anti-HCV test offers high sensitivity and specificity and performed comparably to both the OraQuick assay and InTec assay for HCV diagnosis. Thus, the Well test represents a new tool for universal HCV screening to identify infected patients, particularly in regions with limited medical resources.
丙型肝炎病毒（HCV）感染是一个公共卫生问题，迫切需要一种有效的通用筛查方法。口服抗 HCV 检测可以为 HCV 感染提供一种非侵入性和快速的筛查策略。本研究评估了 Well 公司开发的一种新的即时口服 HCV 抗体检测方法的性能。
本研究纳入了来自三个中心的 HCV 感染和非感染个体。所有参与者均采用 Well 检测法进行口服 HCV 抗体检测，采用已建立的检测方法（ARCHITECT i2000 抗 HCV 检测法和 InTec 血清抗 HCV 检测法）进行血清 HCV 抗体检测。对于获得阳性结果的参与者，进行 HCV RNA 检测以进行验证。一些患者同时接受了 OraQuick HCV 检测，一些患者在同一时期自行使用 Well 检测法进行检测。
共纳入 1179 名参与者，包括 486 名慢性 HCV 感染患者、108 名其他肝病患者和 585 名体检者。Well 抗 HCV 检测法对口服 HCV 抗体检测的敏感性为 91.88%（95%置信区间[CI]：88.97-94.09%），特异性为 98.00%（96.58-98.86%）。Well 检测法与 InTec 检测法的一致性为 97.02%（1138/1179）。Well 检测法与 OraQuick 检测法的一致性为 98.50%（197/200）。此外，自我检测的结果与研究者进行的检测高度一致（Kappa=0.979）。此外，HCV RNA 结果还表明，在 39 份假阴性样本中仅能检测到 1 份 HCV RNA，对于 172 份阳性 HCV RNA 结果，171 份可通过 Well 口服抗 HCV 检测法检测到。
Well 口服抗 HCV 检测法具有较高的敏感性和特异性，与 OraQuick 检测法和 InTec 检测法在 HCV 诊断方面具有可比性。因此，该检测法代表了一种新的通用 HCV 筛查工具，可用于识别感染患者，特别是在医疗资源有限的地区。
