Low-level hepatitis B surface antigen by ECLIA stratifies early relapse risk in patients with interferon-based HBV functional cure
By
Xiangyong Li
Baoer Wu
Huaping Xie
Hao Hu
Ting Liu
Xu You
Yanhua Bi
Yurong Gu
July 8, 2026
Clinical Scorecard: Detection of Low-Level Hepatitis B Surface Antigen via ECLIA Enhances Early Relapse Risk Assessment in Patients Achieving Interferon-Induced HBV Functional Cure
At a Glance
Category Detail
Condition Chronic Hepatitis B (CHB) Key Mechanisms High-sensitivity electrochemiluminescence immunoassay (ECLIA) detects low-level residual HBsAg, improving relapse risk assessment. Target Population Adult, non-cirrhotic patients with chronic hepatitis B achieving functional cure. Care Setting Clinical practice for chronic hepatitis B management.
Key Highlights
ECLIA-HBsAg is a sole independent predictor of relapse (HR: 9.32). Cumulative relapse rates at 48 weeks post-treatment cessation were 8.2%. Optimal ECLIA-HBsAg cutoff for relapse risk is 0.38 COI. Mean lead-time gain of ECLIA over ELISA was 28 weeks for functional relapsers. Standard ELISA may misclassify patients as cured, leading to relapse. Guideline-Based Recommendations
Diagnosis
Use high-sensitivity ECLIA for more accurate assessment of HBsAg levels. Management
Consider ECLIA results when determining treatment discontinuation in CHB patients. Monitoring & Follow-up
Regular monitoring of HBsAg levels using ECLIA post-treatment is recommended. Risks
Patients with low-level residual HBsAg may experience relapse despite meeting conventional cure criteria. Patient & Prescribing Data
292 CHB patients who achieved interferon-induced functional cure.
ECLIA provides a more sensitive measure for assessing relapse risk compared to conventional ELISA.
Clinical Best Practices
Incorporate ECLIA in routine clinical practice for defining 'deep functional cure'. Utilize ECLIA for better risk stratification in patients discontinuing antiviral therapy. Related Resources & Content
