Year: 2026
Type: article
Abstract: Detection of anti-hepatitis A virus (anti-HAV) IgM antibodies is essential for diagnosing acute hepatitis A. In this multicenter comparative study, the following three automated immunoassay platforms widely used in Korean clinical laboratories were evaluated: Architect i2000 (Abbott Laboratories, USA), DxI 800 (Beckman Coulter, USA), and Cobas e801 (Roche Diagnostics, Germany).Thirty-two residual sera, either confirmed or clinically suspected of acute hepatitis A, were collected from three institutions.Each sample was tested using all three analyzers, and the results were interpreted according to manufacturer cut-offs.Among the 32 tested sera, DxI 800 yielded 29 positive results (90.6%); Architect i2000, 19 positive results (59.4%) and 13 gray-zone results (40.6%); and Cobas e801, 15 positive results (46.9%).The results from all three assays were concordantly positive for 13 samples (40.6%); when the gray-zone results from Architect i2000 were regarded as positive, the number of concordant positive results across all platforms increased to 15 samples (46.9%).The quantitative correlation between assays was strong (r=0.702-0.911,P<0.001).ROC analysis revealed that increasing the DxI 800 cut-off from 1.0 to 4.16 improved specificity from 28.6% to 100% without loss of sensitivity.Architect i2000 and Cobas e801 maintained high specificity, though sensitivity varied slightly depending on cut-off.Considerable qualitative discrepancies were detected among the anti-HAV IgM immunoassays, despite strong quantitative correlation.Adjusting the DxI 800 cut-off substantially reduced false positive results, while preserving diagnostic accuracy.
Authors: Hyejin Ryu, Soo-Kyung Kim, Hyeyoung Lee
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7166167360
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