Roche Diagnostics has announced that the US Food and Drug Administration (FDA) has granted premarket approval for its Elecsys antibody to hepatitis C virus (anti-HCV) assay.
The Elecsys Anti-HCV assay is an in-vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma.
Roche received approvals for the anti-HCV test on three platforms: the standalone Cobas e411 analyser for low-volume testing; and the Cobas e601 and Modular chemistry systems for mid-volume and high-volume testing, respectively.
The anti-HCV assay is an 18-minute test designed for use with Roche's electrochemiluminescence (ECL) technology.
Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk of hepatitis C infection.
The test does not determine the state of infection or associated disease.
The Elecsys anti-HCV assay is anticipated to ship in July.
