FDA Approves First Rapid HCV Antibody Test

Yael Waknine

June 28, 2010

June 28, 2010 — The US Food and Drug Administration (FDA) has approved the first rapid blood test for antibodies to the hepatitis C virus (OraQuick HCV Rapid Antibody Test; OraSure Technologies, Inc) in patients aged 15 years and older who are at risk for HCV or have signs/symptoms of hepatitis.

According to information on the company Website, the portable device uses a test strip that detects all HCV genotypes in about 20 to 40 minutes from samples of oral fluid, fingerstick/venipuncture whole blood, or collected serum/plasma. Test accuracy is greater than 99% with whole blood and serum/plasma samples but is somewhat less accurate with oral samples.

Once the sample is collected, the device is inserted into the buffer, and results are read on the device face as nonreactive (1 line) or reactive (2 lines). Mixing with the buffer solution is required for all samples not obtained orally.

"The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, from the University of Miami School of Medicine, Florida, in a company news release. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."

HCV is transmitted via exposure to infected blood and also from mother to child. Although most individuals have few symptoms after initial infection, the virus persists in the liver to cause chronic infection in about 75% to 85% of cases. Chronic HCV affects about 3.2 million Americans, causing 12,000 deaths annually, and is a leading cause of liver transplants in the United States.

"Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in an agency news release. "Getting faster treatment is an important public health step to control this dangerous disease."

The FDA notes that the point-of-care test is not approved for HCV screening purposes in the general population.

The rapid HCV antibody test previously was granted the CE mark by the European Commission, allowing its use in the European Union.

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