BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

中文翻译：

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评估用于筛查丙型肝炎病毒感染的新型即时护理口服抗HCV测试。

背景技术丙型肝炎病毒（HCV）感染是公共卫生问题，为此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感染提供非侵入性的快速筛查策略。这项研究评估了Well为检测HCV抗体开发的新型即时护理口服检测的性能。方法招募来自三个中心的有无HCV感染的个体。所有受试者均使用Well试验检测口服HCV抗体，并使用既定试验（ARCHITECT i2000抗HCV试验和InTec血清抗HCV试验）检测血清HCV抗体。对于获得阳性结果的参与者，对HCV RNA进行了测试以进行验证。一些患者在同一时间进行了OraQuick HCV测试，而一些患者在同一时期通过Well分析进行了自我测试。结果共纳入1179名参与者，其中包括486例慢性HCV感染患者，108例其他肝病患者和585例接受了身体检查的患者。Well抗HCV检测的口服HCV抗体检测灵敏度为91.88％（95％置信区间[CI]：88.97-94.09％），特异性为98.00％（96.58-98.86％）。Well和InTec分析之间的一致性为97.02％（1138/1179）。Well和OraQuick分析之间的一致性为98.50％（197/200）。此外，自我测试的结果与研究者管理的测试结果高度一致（Kappa = 0.979）。此外，HCV RNA结果还显示，仅在39个假阴性样品中的1个中可以检测到HCV RNA，对于172个阳性HCV RNA结果，通过Well口服抗HCV分析可以检测到171个。结论Well口服抗HCV检测具有很高的灵敏度和特异性，与OraQuick和InTec的HCV诊断性能相当。因此，Well测试代表了一种用于进行通用HCV筛查以识别感染患者的新工具，尤其是在医疗资源有限的地区。