HCV is a potential cause of viral hepatitis, which leads to blood-borne chronic hepatitis, liver cirrhosis and hepatocellular carcinoma. Anti-HCV antibody detection assays detect HCV infection after approximately 70 days. HCV core antigen can be detected much earlier than anti-HCV antibodies. However, it disappears soon after the appearance of anti-HCV antibodies. Thus, there is a need for a rapid assay for simultaneous detection of HCV core antigen and anti-HCV antibodies for early diagnosis of HCV infection. A rapid diagnostic assay (HCV Ag-Ab Combo) for simultaneous detection of HCV core antigen and anti-HCV antibodies for early diagnosis of HCV infection was developed. HCV Ag-Ab Combo was evaluated in order to determine its potential for detection of HCV infection earlier than anti-HCV antibody detection assays. We compared the sensitivity of the newly developed assay with anti-HCV antibody detection assays (ELISA [HCV Ab ELISA] and rapid test [HCV Ab Rapid]) and HCV core antigen/anti-HCV antibody detection ELISA (HCV Ag-Ab ELISA). This study included 11 samples that were found positive in HCV RNA detection and HCV Ag-Ab ELISA but negative in HCV antibody detection assays (HCV Ab ELISA and rapid), 10 samples that were found positive in HCV Ag-Ab ELISA and HCV Ab ELISA but negative in HCV Ab Rapid, 69 samples that were found positive in HCV Ag-Ab ELISA, HCV Ab ELISA, and HCV Ab Rapid, and 509 samples that were found negative in HCV Ag-Ab ELISA, HCV Ab ELISA, and HCV Ab Rapid. Three seroconversion panels, PHV 913, PHV 911 (M) and PHV904-00-1.0, and a HCV RNA genotype qualification panel (2400-0182) acquired from Seracare Life Sciences (USA) were also tested. HCV Ag-Ab Combo showed a combined sensitivity and specificity of 100% when tested with 90 samples that were positive for HCV by HCV Ag-Ab ELISA and 509 HCV-negative samples. Its positive predictive value (PPV) and negative predictive value (NPV) were found to be 100%. It detected HCV infection approximately 7 to 12 days earlier than the HCV Ab detection assays, and its performance was not affected when testing different genotypes of HCV. HCV Ag-Ab Combo did not detect HCV infection as early as HCV RNA or HCV Ag-Ab ELISA. HCV Ag-Ab Combo provided a significant improvement for the early detection of HCV infection during the preseroconversion phase when compared with anti-HCV antibody detection assays. It could be a useful screening assay, and an alternative to HCV RNA detection or HCV Ag-Ab ELISA when nucleic acid technologies cannot be implemented.

中文翻译：

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同时检测丙型肝炎病毒核心抗原和抗体的新型快速免疫测定设计。

HCV是病毒性肝炎的潜在原因，可导致血液传播的慢性肝炎，肝硬化和肝细胞癌。约70天后，抗HCV抗体检测方法可检测HCV感染。可以比抗HCV抗体更早地检测到HCV核心抗原。但是，抗HCV抗体出现后很快消失。因此，需要用于同时检测HCV核心抗原和抗HCV抗体的快速测定法以早期诊断HCV感染。开发了一种快速诊断测定法（HCV Ag-Ab Combo），用于同时检测HCV核心抗原和抗HCV抗体，以早期诊断HCV感染。评估HCV Ag-Ab组合是为了比抗HCV抗体检测试验更早地确定其检测HCV感染的潜力。我们将新开发的测定与抗HCV抗体检测测定（ELISA [HCV Ab ELISA]和快速检测[HCV Ab Rapid]）和HCV核心抗原/抗HCV抗体检测ELISA（HCV Ag-Ab ELISA）的敏感性进行了比较。这项研究包括11份在HCV RNA检测和HCV Ag-Ab ELISA中呈阳性但在HCV抗体检测测定（HCV Ab ELISA和快速）中呈阴性的样品，10份在HCV Ag-Ab ELISA和HCV Ab ELISA中呈阳性但在HCV Ab-Ab Rapid中呈阴性，在HCV Ag-Ab ELISA，HCV Ab ELISA和HCV Ab Rapid中呈阳性的69个样品，在HCV Ag-Ab ELISA，HCV Ab ELISA和HCV Ab中呈阴性的509个样品快速。三个血清转换面板，PHV 913，PHV 911（M）和PHV904-00-1.0，还测试了从Seracare Life Sciences（美国）获得的HCV RNA基因型鉴定小组（2400-0182）。当用HCV Ag-Ab ELISA对HCV呈阳性的90个样品和509 HCV阴性样品进行检测时，HCV Ag-Ab Combo的综合敏感性和特异性为100％。发现其阳性预测值（PPV）和阴性预测值（NPV）为100％。它比HCV Ab检测检测法早约7至12天检测到HCV感染，并且在测试不同基因型的HCV时其性能不受影响。HCV Ag-Ab Combo最早在HCV RNA或HCV Ag-Ab ELISA之前都未检测到HCV感染。与抗HCV抗体检测方法相比，HCV Ag-Ab组合在血清转换前阶段早期检测HCV感染方面提供了显着改进。