FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

The U.S. Food and Drug Administration today (June 25) announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

“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, M.D., J.D., 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 U.S. 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 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

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

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FDA Clears Rapid Test for Avian Influenza A Virus in Humans

The U.S. Food and Drug Administration today cleared for marketing a new, more rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans.

The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results.

“This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.”

Influenza A infects both humans and animals. H5N1 is a subtype that is found mostly in birds, although infections have also occurred in humans, mostly in people who have come into contact with the virus through infected poultry. According to the Centers for Disease Control and Prevention, of the few avian influenza viruses that have infected humans, the H5N1 subtype has caused the largest number of detected cases of serious disease and death.

There is a possibility that the influenza A/H5N1 virus subtype could mutate further and spread quickly to humans, causing an influenza pandemic. According to the World Health Organization, there are 412 confirmed human cases of infection from this virus, almost all in Asia and northern Africa. This virus subtype, which can cause life-threatening illness, has not been detected in the Americas.

In clinical studies, the test correctly identified the absence of infection in more than 700 specimens. In addition, the test correctly detected the presence of influenza A/H5N1 virus subtype in 24 cultured specimens from infected patients.

AVantage A/H5N1 Flu Test is manufactured by Arbor Vita Corporation, located in Sunnyvale, Calif.

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