Elecsys Anti-HBc II
The FDA has authorized the Elecsys Anti-HBc II, an in vitro immunoassay designed for the qualitative detection of antibodies to the hepatitis B core antigen (anti-HBc) in human serum and plasma.
This update primarily affects Roche Diagnostics, clinical laboratory professionals, and regulatory teams responsible for infectious disease diagnostic testing and blood screening oversight.
This authorization adds to the available diagnostic toolkit for identifying past or present hepatitis B infections. The inclusion of both serum and plasma matrices suggests flexibility in clinical workflow, though regulatory teams must ensure that specific usage cases remain within the defined qualitative scope of the immunoassay.
Regulatory and laboratory personnel should verify that current testing protocols for hepatitis B screening align with the qualitative specifications of this immunoassay. QA teams should ensure validation documentation supports the use of both serum and plasma matrices as specified in the labeling.
Elecsys Anti-HBc II is an in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma.
Open in openFDA / FDA.gov