Roche Gains FDA Approval for Elecsys HBsAg II Screening and Confirmatory Assay Platform

Source plasma manufacturers and biologics facilities operating under 21 CFR Part 610 donor testing requirements now have an FDA-licensed electrochemiluminescence option for hepatitis B surface antigen screening: Roche Diagnostics received approval for the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm platform, with the confirmatory assay cleared under STN 125802/0 and an initial approval letter dated February 21, 2024, followed by a subsequent Elecsys HBsAg II letter dated February 17, 2026.

The Elecsys HBsAg II is indicated for qualitative HBsAg detection in human serum and plasma across a broad donor population: volunteer whole blood and blood component donors, source plasma donors, and organ, tissue, and cell donors, including cadaveric specimens collected post-cardiac arrest. One explicit exclusion applies: cord blood specimens fall outside the cleared indication. The companion Elecsys HBsAg II Auto Confirm is indicated specifically to confirm HBsAg presence in samples that test repeatedly reactive on the primary assay, covering the same living-donor categories but not cadaveric specimens.

Both assays are designed for use with the cobas pro serology solution, meaning facilities will need to assess instrument compatibility before integrating either test into existing donor screening workflows. For QA directors managing method validation packages, the electrochemiluminescence (ECLIA) technology represents a platform shift from conventional enzyme immunoassay formats, and validation protocols should reflect that distinction under ICH Q10 quality system expectations and applicable CLIA requirements.

The two-assay architecture, screen then confirm, aligns with the tiered testing logic already embedded in blood establishment SOPs, but the separate approval letters and package inserts for each component, including distinct PreciControl reference materials, mean change control documentation will need to address each product individually. Regulatory affairs leads at plasma fractionators and blood establishments should verify that their biologics license applications or supplements reflect the specific STN and intended use boundaries, particularly the cadaveric donor restriction that applies only to the screening assay.

The Summary Basis for Regulatory Action, published alongside the February 2024 approval, provides the analytical and clinical data package that QA and regulatory teams will need to reference when preparing validation reports or responding to FDA inspection inquiries about donor screening method selection.

Facilities moving toward implementation should anchor their timelines to the cobas pro instrument qualification schedule, as platform readiness will govern when the validated method can be placed into routine donor screening use.

Source: FDA Center for Biologics Evaluation and Research (CBER), Approved Blood Products listing via FDA.gov RSS Feed, published July 8, 2026.