June 2, 2010 — The US Food and Drug Administration (FDA) has granted premarket approval for an electrochemiluminescence immunoassay (Elecsys Anti-HCV; Roche Diagnostics Corp) for the qualitative detection of total antibodies to the hepatitis C virus (HCV) in human serum or plasma.
HCV infection is primarily contracted through contaminated blood and blood products and frequently leads to chronic hepatitis and cirrhosis; it has also been linked to the development of hepatocellular carcinoma.
Results of the 18-minute immunoassay are indicated in conjunction with other laboratory results and clinical information as an aid for the presumptive diagnosis of HCV infection in at-risk patients and those with related signs and symptoms. The test does not determine the state of infection or associated disease.
According to a company news release, the anti-HCV test has been approved for use on 3 platforms made by Roche: the stand-alone Cobas e 411 analyzer for low-volume testing and the Cobas e 601 and Modular Analytics e 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for midvolume and high-volume testing, respectively.
The test is expected to ship in July 2010.
In April, the FDA granted 510k clearance for another electrochemiluminescence immunoassay (Elecsys Rubella IgM; Roche) for the qualitative determination of immunoglobulin M antibodies to rubella virus in human serum and plasma. The test is indicated as an aid in the presumptive diagnosis of acute or recent rubella infection, particularly in women of childbearing age.