Elecsys Anti-HBc II

The Elecsys Anti-HBc II is an immunoassay that qualitatively detects total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma from adult and pediatric patients (2-21 years) with hepatitis symptoms or at risk for HBV infection. It uses electrochemiluminescence (ECLIA) on cobas e immunoassay analyzers with a 27-minute test time and is intended as an aid in laboratory diagnosis of HBV infection, not for disease monitoring.

The Elecsys Anti-HBc II uses a competition principle with pretreatment, while the Abbott ARCHITECT CORE predicate uses a two-step immunoassay. Both detect the same analyte (total anti-HBc). Key differences include test principle, sample matrix specifications (potassium EDTA vs. dipotassium EDTA), calibrators, and instrument platform (cobas e vs. ARCHITECT iSystem).

Not stated in this summary.

Substantial equivalence is supported by the same regulatory classification (21 CFR 866.3173), product code (SEI), and intended use of detecting anti-HBc antibodies for HBV diagnosis. Performance evaluation showed 100% negative predictive agreement in 119 pediatric samples and spiking studies with mean absolute difference of 0.0107 COI (meeting ≤0.20 criteria), demonstrating equivalent performance across age groups without changes to assay reagents.