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U.S. Department of Health and Human Services

Medical Devices

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OraQuick HCV Rapid Antibody Test - P080027/S001

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: OraQuick HCV Rapid Antibody Test
Applicant: OraSure Technologies, Inc.
Address: Bethlehem, Pennsylvania
Approval Date: February 18, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080027s001a.pdf

What is it? The OraQuick HCV Rapid Antibody Test determines a patient’s exposure to the hepatitis C virus (HCV).  Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies associated with HCV (anti-HCV antibodies) can help determine if a person is currently infected or has previously been infected with HCV.

How does it work? A sample of a person’s blood, either from a vein or a fingerstick, is added to a tube (vial) with the test chemicals. The test strip is coated with HCV antigens (proteins from the HCV) and is placed into the vial. If there are antibodies to the HCV in the blood, they stick to the test strip and react with the chemicals to produce a colored line on the test strip. The appearance of a line indicates the presence anti-HCV in the patient’s blood. A positive test result should be confirmed with a supplemental test as false positive results may occur.

When is it used? This is the initial laboratory test used for people with signs or symptoms, or who are at risk of HCV infection.

What will it accomplish? The test result is used in combination with other clinical information and blood tests to aid in the diagnosis of individuals with signs or symptoms of hepatitis, or in individuals at risk for hepatitis C infection.

When should it not be used? This test should not be used to make a final diagnosis of HCV infection. If this test is positive, more tests will be required to determine if the person is infected. This test should not be used for screening patients without signs or symptoms of HCV or for blood donors, because it has not been proven effective for these purposes. The test should be used only when prescribed by a physician.

Additional information: Summary of Safety and Effectiveness and labeling are available online.

Other Resources: