1. Hepatitis C virus antigens enzyme immunoassay for one-step diagnosis of hepatitis C virus coinfection in human immunodeficiency virus infected individuals
- Author
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Xie, Qing, Xuan, Jian-Wei, Tang, Hong, Ye, Xiao-Guang, Xu, Peng, Lee, I-Heng, and Hu, Shan-Lian
- Subjects
Medical Microbiology ,Biomedical and Clinical Sciences ,Immunology ,Digestive Diseases ,Infectious Diseases ,Hepatitis ,Hepatitis - C ,Emerging Infectious Diseases ,HIV/AIDS ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Infection ,Good Health and Well Being ,Diagnostic assay ,Enzyme immunoassay ,Hepatitis C virus ,Hepatitis C virus antigens ,Hepatitis C virus core antigen ,Hepatitis C virus diagnostic test ,Clinical sciences - Abstract
BackgroundCurrent 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.AimTo assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in human immunodeficiency virus (HIV)-coinfected individuals.MethodsThe 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; and 45 with viremic HCV and non-viremic HIV coinfection.ResultsUpon 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 as 50-59 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.ConclusionThe 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.
- Published
- 2019