ArticleFrontiers in immunology2026
Low-level hepatitis B surface antigen by ECLIA stratifies early relapse risk in patients with interferon-based HBV functional cure.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Current definitions of functional cure in chronic hepatitis B (CHB) rely on conventional assays of HBsAg tested by enzyme-linked immunosorbent assay (ELISA-HBsAg), which may misclassify patients with low-level residual antigenemia as cured, leading to relapse after treatment cessation. This study aims to investigate whether high-sensitivity electrochemiluminescence immunoassay of HBsAg (ECLIA-HBsAg) can provide a much better definition of deep functional cure in CHB patients discontinuing interferon (IFN) add-on therapy. Methods: This retrospective study included 292 CHB patients reaching interferon-induced functional cure with HBsAg tested by ELISA and conducted a 48-week follow-up. Clinical-virological data were collected at treatment cessation and during follow-up. HBsAg were measured by ELISA and ECLIA, simultaneously. LASSO-Cox regression was used for predictor selection. Model performance was evaluated using time-dependent ROC curves, calibration analysis, and decision curve analysis (DCA). The optimal cutoff was determined via maximally selected rank statistics. Results: During a 48-week follow-up, 24 patients (8.2%) in total relapsed. Cumulative relapse rates at 12, 24, 36, and 48 weeks were 1.4%, 3.8%, 6.2%, and 8.2%, respectively. ECLIA-HBsAg emerged as the sole independent predictor (HR: 9.32, 95% CI: 4.97-17.47, p<0.001), with an optimal cutoff of 0.38 COI. Patients with ECLIA-HBsAg >0.38 COI exhibited a significantly higher relapse risk (p=0.0029). The model demonstrated strong discrimination (C-index: 0.805; AUCs at 24/36/48 weeks: 0.790, 0.789, and 0.768, respectively) and high clinical utility.The mean lead-time gain of ECLIA-HBsAg over ELISA-HBsAg was 28 weeks in functional relapsers (95% CI: 20.5-35.5 weeks, p < 0.001). Conclusions: Patients who experience relapse under conventional ELISA definitions often harbor residual HBsAg detectable by high-sensitivity testing. Based on an exploratory cutoff of 0.38 COI, we propose that highly sensitive ECLIA might be incorporated into clinical practice as a new, more stringent standard for defining "deep functional cure".
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