Analytical performance of newly developed rapid point-of-care test for the simultaneous detection of hepatitis A, B, and C viruses in serum samples.

ABSTRACTBACKGROUND

Although immunoassays play a major role in the detection of hepatitis viruses, there is a need for a point-of-care (POC) test. We evaluated the EuDx-HE (A,B,C) kit (EUDIPIA, Cheongju, Korea), which detects anti-hepatitis A virus (HAV) immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), and anti-hepatitis C virus (HCV) immunoglobulin G (IgG) simultaneously using an immunochromatographic method within 15 minutes.

METHODS

A total of 1581 serum samples including 57, 477, and 451 samples positive for anti-HAV IgM, HBsAg, and anti-HBV IgG, respectively, were analyzed. We investigated the diagnostic accuracy of the EuDx-HE (A,B,C) kit by comparison with SD BIOLINE POC kits (Abbott, Chicago, IL) using Architect immunoassays as a reference method.

RESULTS

For anti-HAV IgM and HBsAg detection, the EuDx-HE (A,B,C) kit showed a higher sensitivity and a slightly lower specificity than the SD BIOLINE kit. For anti-HCV IgG detection, the EuDx-HE (A,B,C) kit had a higher sensitivity and a higher specificity than the SD BIOLINE kit. The agreement for positivity between the POC tests was >89.47%, with κ values of 0.844, 0.941, and 0.943 for HAV, HBV, and HCV, respectively.

CONCLUSION

The EuDx-HE (A,B,C) kit showed an acceptable clinical performance for detecting anti-HAV IgM, HBsAg, and anti-HCV.