Rapid Test for Antibodies to Hepatitis C Virus Approved by the US Food and Drug Administration

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The US Food and Drug Administration (FDA) announced approval on June 25 of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals ≥15 years old. It is the only rapid, point-of-care test for the detection of antibodies to the HCV in venous whole blood specimens to gain FDA approval.

The OraQuick HCV Rapid Antibody Test can read blood samples and is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. It is a test strip that does not require an additional instrument for diagnosis and provides results in about 20–40 minutes with 99% accuracy. The test strip treated with the sample is read on a device and provides a result as either reactive or nonreactive.

“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. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

According to the US Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17 000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12 000 deaths annually. Approximately 75%–85% of people who become infected with the HCV develop chronic infection.

OraQuick is manufactured by Bethlehem, Pennsylvania-based OraSure Technologies Inc.