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KMID : 0985420210430020080
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Laboratory Medicine and Quality Assurance
2021 Volume.43 No. 2 p.80 ~ p.86
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Improvement of the Accuracy of Hepatitis B Surface Antigen Testing Using a Confirmatory Test
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Huh Hee-Jin
Park Shol-Hui
Huh Jung-Won
Lee Mi-Ae
Kim Soo-Kyung
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Abstract
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Background: The hepatitis B surface antigen (HBsAg) is one of the most important serologic markers in diagnosing hepatitis B virus infection. As more sensitive immunoassays become available, the false positive rate of HBsAg has been increasing. Therefore, it has been suggested that a standardized HBsAg testing strategy be implemented to maximize the accuracy and minimize cost and complexity. This study evaluated HBsAg confirmatory tests and the HBsAg testing process to reduce false-positive HBsAg results, and the financial and time burden of the laboratory.
Methods: Samples with Elecsys HBsAg II (Roche Diagnostics, Germany) cutoff index (COI) 0.9?50.0 and Alinity i HBsAg (Abbott, Ireland) signal-to-cutoff (S/CO) 1.0?30.0 were analyzed with the Elecsys HBsAg confirmatory test (Roche Diagnostics) and the Alinity i HBsAg qualitative II confirmatory test (Abbott), respectively.
Results: The Elecsys and Alinity confirmatory tests were positive in 94.0% (47/50) and 69.4% (25/36) of tested samples, respectively. HBsAg COI results were significantly higher in the confirmatory test positive group than the confirmatory test negative group (Elecsys HBsAg median COI 1.20 vs. 4.38 [P =0.024] and Alinity HBsAg median S/CO 1.36 vs. 4.65 [P =0.000]). HBsAg test specificity was 100% with Elecsys COI 1.3 and Alinity S/CO 2.9.
Conclusions: The HBsAg value which is likely to be positive in the neutralization test, differed depending on the patient population and reagents. By performing a neutralization test for weakly positive samples below the cutoff and adapting a single serological test strategy for samples above the cutoff, we expected to decrease false-positive results, with less time and effort.
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KEYWORD
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Hepatitis B surface antigen, Confirmatory test, Neutralization test
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