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U.S. Department of Health and Human Services

Medical Devices

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VERSANT™ HCV RNA Qualitative Assay - P020011

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: VERSANT™ HCV RNA Qualitative Assay
Manufacturer: Gen-Probe, Inc.
Address: 10210 Genetic Center Drive, San Diego, CA 92121-1589
Approval Date: November 7, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020011a.pdf

What is it? This test shows whether a person is actively infected with hepatitis C virus (HCV). HCV chronically infects several million Americans.

How does it work? Usually, the blood of a person infected with HCV has only a tiny amount of HCV. This makes it hard for a laboratory to detect the infection. The VERSANT™ HCV RNA Qualitative Assay takes genetic material from inside viruses in the patient’s blood and uses enzymes to produce enough HCV genetic material for detection in the laboratory.

When is it used? The VERSANT™ HCV RNA Qualitative Assay is used for patients suspected to be actively infected with HCV who have antibody evidence of HCV infection , those with evidence of liver disease who have HCV antibodies, and those who may be at risk for HCV infection who have HCV antibodies. Results should be interpreted along with additional clinical and laboratory findings.

What will it accomplish? A positive test result indicates that HCV is reproducing itself and is evidence of active HCV infection. However, a negative test result does not rule out the possibility of active HCV infection.

When should it not be used?

  • On patients who do not have antibodies to HCV
  • To screen blood, plasma or tissue donors

Additional information: Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020011