Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Sẵn có từ:

Roche Diagnostics Australia Pty Limited

Lớp học:

Class 4

Sản xuất bởi:

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

Khu trị liệu:

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

Chỉ dẫn điều trị:

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.