Comparison of Rapid Point-of-Care Tests for Detection of Antibodies to Hepatitis C Virus.

Abstract

Background. Hepatitis C is one of the most prevalent blood-borne diseases in the United States. Despite the benefits of early screening, among 3.2 million Americans who are infected with hepatitis C virus (HCV), 50%-70% are unaware of their infection status. Methods. Data were collected between 2011 and 2014, from 1048 clients who were in the following groups: (1) injection drug users, (2) women at sexual risk, (3) gay and bisexual men, and (4) transgender individuals. The sensitivity and specificity of point-of-care tests included (1) the MedMira rapid human immunodeficiency virus (HIV)/HCV antibody test, (2) MedMira hepatitis B (HBV)/HIV/HCV antibody test, (3) Chembio HCV Screen Assay used with both whole blood and (4) oral specimens, (5) Chembio HIV-HCV Assay also used with both whole blood and (6) oral specimens, (7) Chembio HIV-HCV-Syphilis Assay, and (8) OraSure HCV Rapid Antibody Test used with whole blood. The gold standard for the HCV tests were HCV enzyme immunoassay (EIA) 2.0. Results. OraSure had the highest sensitivity at 92.7% (95% confidence interval [CI] = 88.8%-96.5%) followed closely by Chembio's 3 blood tests at 92.1% (95% CI = 87.7%-96.4%), 91.5% (95% CI = 87.2%-95.7%), and 92.3% (95% CI = 88.4%-96.2%). The sensitivities of MedMira HIV/HCV and MedMira HIV/HCV/HBV tests were the lowest, at 79.1% (95% CI = 72.6%-85.5%), and 81.5% (95% CI = 75.2%-87.8%), respectively. Specificity for the OraSure was 99.8% (95% CI = 99.4%-100%); specificity for the Chembio blood tests was 99.2% (95% CI = 98.6%-99.9%), 99.4% (95% CI = 98.8%-99.9%), and 99.3% (95% CI = 98.8%-99.9%); and specificity for the MedMira was100% and 100%. False-negative results were associated with HIV and hepatitis B core antibody serostatus. Conclusions. The OraSure and Chembio blood tests (including those multiplexed with HIV and syphilis) appear to good performance characteristics. This study has identified potential limitations of rapid testing in those testing positive for HIV and HBcAb. There should be discussion of updates to the 2013 CDC guidance.