Background
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.