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FDA grants waiver for HCV test
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The FDA has granted OraSure Technologies a Clinical Laboratory Improvement Amendments waiver for its rapid blood test for hepatitis C virus.
This is the first blood test of its kind, according to a company press release. The OraQuick HCV Rapid Antibody Test can be used to test those who may be at risk for HCV infection or who display signs or symptoms associated with hepatitis.
The waiver will allow distribution and use of the test beyond traditional laboratory settings to include physicians’ offices, health department clinics and other counseling or testing facilities.
The test has a 20-minute response time, is read visually and does not require another instrument for diagnosis. It qualified for the waiver after results indicated the safety, simplicity and accuracy of the test, according to the release.