This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Bayer Versant™ HCV RNA 3.0 Assay (bDNA)
Manufacturer: Bayer Diagnostics
Address: PO Box 2466, Berkeley, CA 94702-0466
Approval Date: March 28, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020022a.pdf
What is it? This laboratory test measures the amount of hepatitis C viral RNA in a patient’s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. This test is used with the Bayer System 340 bDNA Analyzer.
How does it work? In a laboratory, a sample of a patient’s blood is put into a tiny special container in a Bayer System 340 bDNA Analyzer. The Analyzer adds a series of chemicals that react with genetic material from the hepatitis C virus to ultimately produce light. The Analyzer measures the light, which shows how much hepatitis C viral RNA there was in the patient’s blood.
When is it used? A doctor uses this test two or more times while treating a patient with antiviral therapy to see if the patient has not responded to the anti-viral treatment.
What will it accomplish? This test will tell the doctor and patient if antiviral treatment has failed to help cure the patient of hepatitis C infection.
When should it not be used? The assay should not be used to determine if a person is infected with hepatitis C virus. It should not be used to screen blood or blood products for transfusion. And, it should not be used to predict whether an antiviral treatment will be successful.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020022