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[Comparative Evaluation of a New-Generation HBsAg Assay versus a Conventional Method in Occult HBV Infection and
Ferhat Osman Daşdemir1, Harika Öykü Dinç2, Serhat Sirekbasan3
1İstanbul Arel University Vocational School, Department of Environmental Protection Technologies, İstanbul, Türkiye.
Abstract:
This study aimed to comparatively evaluate the conventional hepatitis B surface antigen (HBsAg) assay and the next-generation HBsAg NEXT (HBsAgNx) assay in samples with low-level HBsAg positivity and in cases of occult hepatitis B infection (OBI). A total of 497 individuals were included in the study, comprising 300 individuals with low-level HBsAg positivity, 100 OBI cases (64 seropositive and 36 seronegative) and 97 healthy controls. Serum samples were analyzed using the Abbott ARCHITECT HBsAg Qualitative II assay (Abbott Diagnostics, Wiesbaden, Germany) and the Abbott Alinity i HBsAg NEXT assay (Abbott Diagnostics, Wiesbaden, Germany). The presence of HBV DNA was confirmed by real-time polymerase chain reaction (Rt-PCR) using the COBAS AmpliPrep/COBAS TaqMan HBV test v2.0 (Roche Diagnostics, Mannheim, Germany). HBV DNA (Rt-PCR) was accepted as the gold standard reference for diagnostic performance evaluation. To minimize potential bias arising from sample selection, individuals with lowlevel HBsAg positivity and OBI cases were analyzed separately. In the low-level HBsAg-positive group, semi-quantitative S/CO values of the assays were compared, whereas in the OBI group, only the detection rates of HBV DNA-positive cases were evaluated. A total of 17 OBI cases (17%) were identified that were tested negative by the conventional assay but positive by the HBsAgNx assay. Differences between the assays were evaluated using the McNemar test and p< 0.05 was considered statistically significant. Median values obtained with the HBsAgNx assay were significantly higher than those obtained with the conventional assay (p< 0.001). The HBsAgNx assay provides clinically significant contributions particularly in the OBI group, by detecting cases that cannot be identified by conventional assays. These findings indicate that the integration of high-sensitivity HBsAg assays into current HBV diagnostic algorithms would increase case detection and contribute to both transfusion safety and the clinical management of OBI.
