The first rapid blood test for antibodies to the hepatitis C virus has received approval from the US Food and Drug Administration (FDA) according to a company press release.
The OraQuick HCV Rapid Antibody Test, manufactured by OraSure Technologies Inc., detects antibody to HCV in blood samples in about 20 minutes and no instrumentation is required.
The new test is indicated for testing individuals 15 years or older who are at risk for infection with HCV, and people with signs or symptoms of hepatitis. It is not approved for HCV screening of the general population.
The test can only be administered in professional medical settings that satisfy the technical requirements for moderate complexity testing under the Clinical Laboratory Improvement Amendments (CLIA).
Results achieved using the OraQuick HCV Rapid Antibody Test are presumptive and a positive test result should be followed up by a confirmatory test using traditional HCV testing methods to make a definitive diagnosis.
Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is usually spread when blood from a person infected with the hepatitis C virus enters the body of someone who is not infected. Today, most people become infected with the hepatitis C virus by sharing needles or other equipment to inject drugs.
Hepatitis C can be either “acute” or “chronic.” Acute hepatitis C virus infection is a short-term illness that occurs within the first 6 months after someone is exposed to the hepatitis C virus. For most people, acute infection leads to chronic infection. Chronic hepatitis C is a serious disease than can result in long-term health problems, or even death.
There is no vaccine for hepatitis C. The best way to prevent hepatitis C is by avoiding behaviors that can spread the disease, especially injection drug use.
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