Evaluation of the OraQuick HCV Rapid Antibody Test as a Screening Test for Hepatitis C Virus Infection / 임상검사와정도관리

ABSTRACT

BACKGROUND: Among the multitude of tests developed for the diagnosis of hepatitis C virus (HCV) infection, the enzyme immunoassay and the chemiluminescence immunoassays (CLIA) are the most commonly used. The OraQuick HCV Rapid Antibody Test is also popular because it can detect HCV antibodies from blood or saliva within 20 minutes. In this study, we compared the performances of the OraQuick HCV Rapid Antibody Test and CLIA in the diagnosis of HCV infection. METHODS: We tested 150 serum samples from Soonchunhyang University Seoul Hospital for HCV between November 2012 and January 2013 using CLIA (ADVIA Centaur) as well as the OraQuick test. The data from both tests were compared to the results of HCV real-time PCR (COBAS AmpliPrep/COBAS TaqMan HCV test kit). RESULTS: In the PCR analysis, 59 of the 150 samples (39.3%) tested positive and 91 (60.7%) tested negative for HCV RNA. All these samples also tested positive when screened by CLIA. However, only 57 of 59 samples tested positive with the OraQuick test. Among the 91 samples found to be HCV-negative in the PCR analysis, 50 tested negative in both CLIA and the OraQuick tests. However, a discrepancy was noted among the remaining 41 samples that tested HCV-negative in the PCR analysis; 21 of these samples tested positive in both CLIA and the OraQuick tests, but the remaining 20 tested positive only in CLIA. CONCLUSIONS: Although the OraQuick test showed a marginally lower sensitivity for HCV detection than CLIA, we conclude that it is still beneficial because it is rapid and can be performed using blood and saliva samples. Our findings suggest that the OraQuick test could be an important diagnostic tool for screening HCV infection.