Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen 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:

48382 - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay

Therapeutic indications:

Elecsys HCV Duo is an electrochemiluminescence immunoassay for the in vitro qualitative detection of hepatitis C virus (HCV) core antigen (HCV Ag) and antibodies to HCV (anti-HCV) in human serum and plasma. Elecsys HCV Duo is an immunoassay for the in vitro qualitative detection of hepatitis C virus (HCV) core antigen (HCV Ag) and antibodies to HCV (anti-HCV) in human serum and plasma. The test in conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of and the screening of HCV infection. The test can also be used as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissue, and organs. The subresults (HCV Ag and anti-HCV) are intended as an aid in the selection of the confirmatory testing algorithm for reactive samples.The electrochemiluminescence immunoassay ?ECLIA? is intended for use on cobas e immunoassay analyzers.