{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T23:10:58Z","timestamp":1778627458592,"version":"3.51.4"},"reference-count":41,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2016,6,27]],"date-time":"2016-06-27T00:00:00Z","timestamp":1466985600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2016,6,27]],"date-time":"2016-06-27T00:00:00Z","timestamp":1466985600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:p>The current standard in diagnosing hepatitis C virus (HCV) infection requires two sequential steps: anti\u2010HCV test to screen, followed by HCV RNA reverse\u2010transcription polymerase chain reaction to confirm viremic HCV (V\u2010HCV) infection. HCV core antigen tests provided potential for possible one\u2010step diagnosis. However, low sensitivity and specificity limit their clinical utility. The present study developed a novel HCV antigens enzyme immunoassay (HCV\u2010Ags EIA) and assessed its sensitivity, specificity, and utility for one\u2010step diagnosis of V\u2010HCV infection using 365 serum specimens, including 176 without and 189 with V\u2010HCV infection. First, we confirmed the presence of HCV nonstructural proteins 3, 4b, and 5a besides HCV core antigen during HCV infection and developed a novel HCV\u2010Ags EIA through simultaneous detection of all four HCV proteins. For the first time, the present study demonstrated that serum sample denaturation decreases the test specificity due to release of HCV\u2010Ags sequestered in HCV immune complexes and should not be used in any HCV\u2010Ags, including all the current HCV core antigen assays. On the other hand, using sample nondenaturation, the HCV\u2010Ags EIA results showed 98.9% specificity and 100% sensitivity compared to serum anti\u2010HCV and HCV RNA reverse\u2010transcription polymerase chain reaction results. Using serum sample dilution, and nondenaturation, the lowest limits of detection of the HCV\u2010Ags EIA were equivalent to serum HCV RNA levels of approximate 150\u2010250 IU\/mL. <jats:italic toggle=\"yes\">Conclusions<\/jats:italic>: The highly specific and sensitive HCV\u2010Ags EIA developed in the present study has the lowest limit of detection equivalent to serum HCV RNA levels of 150\u2010250 IU\/mL; using nondenaturation of serum samples, our HCV\u2010Ags EIA reliably differentiated V\u2010HCV infection from resolved HCV infection, accomplishing screening and diagnosis of V\u2010HCV infection in one step. (H<jats:sc>epatology<\/jats:sc> 2016;64:415\u2010424)<\/jats:p>","DOI":"10.1002\/hep.28663","type":"journal-article","created":{"date-parts":[[2016,6,6]],"date-time":"2016-06-06T13:32:30Z","timestamp":1465219950000},"page":"415-424","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":19,"title":["A highly specific and sensitive hepatitis C virus antigen enzyme immunoassay for One\u2010step diagnosis of viremic hepatitis C virus infection"],"prefix":"10.1097","volume":"64","author":[{"given":"Ke\u2010Qin","family":"Hu","sequence":"first","affiliation":[{"name":"Division of GI\/Hepatology,University of California, Irvine, School of Medicine,Orange,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Cui","sequence":"additional","affiliation":[{"name":"Division of GI\/Hepatology,University of California, Irvine, School of 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