Elecsys HBsAg II Auto Confirm - Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Roche Diagnostics Australia Pty Limited

Class:

Class 4

Manufactured by:

Roche Diagnostics GmbH Sandhofer Strasse 116, Mannheim, D-68305 Germany

Therapeutic area:

60812 - Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Therapeutic indications:

The Elecsys HBsAg II Auto Confirm assay is a fully automated confirmatory assay, based on the principle of specific antibody neutralization, intended to be used for samples repeatedly reactive in the Elecsys HBsAg II assay. Polyclonal HBsAg specific antibodies bind to the immunodominant epitopes of HBsAg and thereby block the binding sites for the antibodies used in the Elecsys HBsAg II assay. Immunoassay and control for in vitro confirmation of the presence of hepatitis B surface antigen in human serum and plasma samples repeatedly reactive when tested with the Elecsys HBsAg II assay. These electrochemiluminescence immunoassays (ECLIA) are intended for use on cobas e immunoassay analysers.

Authorization status:

A

Authorization date:

2022-06-07