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CDx, Hepatitis B Surface Antigen, Quantitative, Immunoassay
Test Code22772
CPT Codes
87467
Preferred Specimen
1 mL serum or
1 mL plasma collected in an EDTA (lavender-top) tube
1 mL plasma collected in an EDTA (lavender-top) tube
Minimum Volume
0.5 mL
Instructions
Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer's instructions for collection tube handling.
Transport Container
Transport tube
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: 90 days
Refrigerated: 7 days
Frozen: 90 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Heat-inactivated samples • Samples with additives other than transport preservatives
Methodology
Electrochemiluminescence Immunoassay
Setup Schedule
Set up: Daily; Report available: 4-6 days
Reference Range
<0.14 IU/mL
Clinical Significance
This assay is intended as a companion diagnostic to guide treatment for bepirovirsen in patients with chronic hepatitis B virus (HBV) infection and should be used in accordance with approved therapeutic product labeling. This assay is not approved for HBV screening or as a diagnostic test to confirm HBV infection, including blood products.
Bepirovirsen is an antisense oligonucleotide HBV antiviral drug targeting all HBV transcripts and is expected to reduce levels of HBV DNA and hepatitis B surface antigen (HBsAg). Quantitative measurements of Hepatitis B surface antigen can be performed at baseline and at the end of treatment. In the B-Well 1 and 2 Phase 3 clinical trials, patients with levels between 100 and 1,000 IU/mL demonstrated the highest rate of functional cure (25% to 28% HBsAg loss) after a finite 24-week regimen of bepirovirsen. Observed functional cure rates in patients with levels between 1,000 and 3,000 IU/mL were lower (5% to 10%) compared to patients with baseline levels ≤1,000 IU/mL. While lower baseline antigen levels are historically associated with favorable treatment responses, clinical data for bepirovirsen in patients with baseline HBsAg <100 IU/mL remains limited.
Values greater than 3,000 IU/mL exceed the cutoff point for predicting response to therapy when HBsAg is tested at baseline.
Baseline HBV DNA suppression (<90 IU/mL on oral therapy) is recommended prior to starting bepirovirsen. Transient, clinically silent ALT elevations (up to 10x ULN) are common (23%) during weeks 5-10 of therapy as a sign of viral clearance. Close liver function monitoring is recommended.
Performance characteristic for this assay has not been established for determining clinical phase of HBV infection or for guiding treatment with other HBV drugs. The results of this should be interpreted in the context of pertinent clinical history and physical examination findings and other laboratory results.
References:
1. Hou J, Seng-Gee L, Buti M, et al. Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. N Engl J Med. 2026 Jun 25;394(24):2395-2406. doi:10.1056/NEJMoa2515131
2. Roche Elecsys HBsAg II quant II RxDx Method Sheet/Investigational Use Only (IUO) Insert (Ref: TARP HBsAgIIqII RxDx, B-Well 1 [NCT05630807]/B-Well 2 [NCT05630820]).
Bepirovirsen is an antisense oligonucleotide HBV antiviral drug targeting all HBV transcripts and is expected to reduce levels of HBV DNA and hepatitis B surface antigen (HBsAg). Quantitative measurements of Hepatitis B surface antigen can be performed at baseline and at the end of treatment. In the B-Well 1 and 2 Phase 3 clinical trials, patients with levels between 100 and 1,000 IU/mL demonstrated the highest rate of functional cure (25% to 28% HBsAg loss) after a finite 24-week regimen of bepirovirsen. Observed functional cure rates in patients with levels between 1,000 and 3,000 IU/mL were lower (5% to 10%) compared to patients with baseline levels ≤1,000 IU/mL. While lower baseline antigen levels are historically associated with favorable treatment responses, clinical data for bepirovirsen in patients with baseline HBsAg <100 IU/mL remains limited.
Values greater than 3,000 IU/mL exceed the cutoff point for predicting response to therapy when HBsAg is tested at baseline.
Baseline HBV DNA suppression (<90 IU/mL on oral therapy) is recommended prior to starting bepirovirsen. Transient, clinically silent ALT elevations (up to 10x ULN) are common (23%) during weeks 5-10 of therapy as a sign of viral clearance. Close liver function monitoring is recommended.
Performance characteristic for this assay has not been established for determining clinical phase of HBV infection or for guiding treatment with other HBV drugs. The results of this should be interpreted in the context of pertinent clinical history and physical examination findings and other laboratory results.
References:
1. Hou J, Seng-Gee L, Buti M, et al. Phase 3 Results of Bepirovirsen Treatment for Chronic Hepatitis B Virus Infection. N Engl J Med. 2026 Jun 25;394(24):2395-2406. doi:10.1056/NEJMoa2515131
2. Roche Elecsys HBsAg II quant II RxDx Method Sheet/Investigational Use Only (IUO) Insert (Ref: TARP HBsAgIIqII RxDx, B-Well 1 [NCT05630807]/B-Well 2 [NCT05630820]).
