Hepatitis C virus antigens enzyme immunoassay for one-step diagnosis of hepatitis C virus coinfection in human immunodeficiency virus infected individuals |
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Authors: | Ke-Qin Hu Wei Cui Susan D Rouster Kenneth E Sherman |
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Affiliation: | Ke-Qin Hu, Wei Cui, Division of GI/Hepatology, University of California, Irvine, School of Medicine, Orange, CA 92868, United StatesSusan D Rouster, Kenneth E Sherman, Division of Digestive Diseases, University of Cincinnati College of Medicine, Cincinnati, OH 45267, United States |
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Abstract: | BACKGROUND Current diagnosis of hepatitis C virus(HCV) infection requires two sequential steps: testing for anti-HCV followed by HCV RNA PCR to confirm viremia. We have developed a highly sensitive and specific HCV-antigens enzyme immunoassay(HCV-Ags EIA) for one-step diagnosis of viremic HCV infection.AIM To assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in human immunodeficiency virus(HIV)-coinfected individuals.METHODS The study blindly tested HCV-Ags EIA for its performance in one-step diagnosing viremic HCV infection in 147 sera: 10 without HCV or HIV infection;54 with viremic HCV monoinfection; 38 with viremic HCV/HIV coinfection; and45 with viremic HCV and non-viremic HIV coinfection.RESULTS Upon decoding, it was 100% accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR test. In five sera with HCV infection, HCV RNA was as low as50-59 IU/mL, and four out of five tested positive for HCV-Ags EIA. Likewise, it was also 100% accordance of HCV-Ags EIA to HCV infection status by HCV RNA PCR in 83 sera with HCV and HIV coinfection, regardless if HIV infection was active or not.CONCLUSION The modified HCV-Ags EIA has a lower detection limit equivalent to serum HCV RNA levels of approximately 100 IU/mL. It is highly sensitive and specific in the setting of HIV coinfection, regardless of HIV infection status and CD4 count.These data support the clinical application of the HCV-Ags EIA in one-step diagnosis of HCV infection in HIV-infected individuals. |
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Keywords: | Hepatitis C virus Hepatitis C virus antigens Hepatitis C virus core antigen Hepatitis C virus diagnostic test Diagnostic assay Enzyme immunoassay |
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