FDA Approval for OraQuick® HCV Rapid Test

OraQuick® Hepatitis C (HCV) Rapid Antibody Test has been approved by the FDA for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

OraQuick® HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick technology platform, provides results in 20 minutes and is the latest rapid test manufactured by OraSure to receive FDA approval.

OraSure had previously received FDA approval for its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.