Published online May 27, 2019. doi: 10.4254/wjh.v11.i5.442
Peer-review started: February 13, 2019
First decision: March 8, 2019
Revised: May 8, 2019
Accepted: May 21, 2019
Article in press: May 21, 2019
Published online: May 27, 2019
Current diagnosis of hepatitis C virus (HCV) infection requires two sequential steps: testing for anti-HCV followed by HCV RNA PCR to confirm viremic infection. We have developed a highly sensitive and specific HCV-antigens (Ags) enzyme immunoassay (EIA) for one-step diagnosis of viremic HCV infection. However, it has not been tested blindly and especially in those with HCV and human immunodeficiency virus (HIV) coinfection.
Although HCV RNA RT-PCR tests are highly sensitive and specific for viremic HCV infection, it is time consuming, costly, and not available and affordable in many developing countries and regions. Further confirming the sensitivity and specificity of HCV-Ags EIA will provide additional support of its clinical value for one-step screening and diagnosing HCV viremic infection.
The present study was aimed to blindly assess the clinical application of the HCV-Ags EIA in one-step diagnosis of viremic HCV infection in HCV-infected and HCV/HIV-coinfected individuals.
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; and 45 with viremic HCV and non-viremic HIV coinfection.
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 test in one-step diagnosis of HCV infection in HIV-infected individuals.
The HCV-Ags EIA will be a novel addition to the current standard and is a more cost-effective one-step HCV screening and diagnosis method.