Fast Flu Test Gets FDA Green Light

A quick at-home nonprescription influenza test that detects flu types A and B within 10 minutes using a simple nasal swab has been granted a CLIA waiver by the U.S. Food and Drug Administration (FDA). The test gives doctors a fast, easy way to diagnose patients in their offices, and provides consumers with the convenience of home testing so they can get prompt treatment by a doctor.

Called the QuickVue Influenza Test, the test is the product of Quidel Corp. (San Diego, CA, USA). CLIA-waived tests are the lowest regulated category and those most used in doctors' offices. The Clinical Laboratory Improvement Amendments (CLIA) established national quality standards for most U.S. laboratories that perform testing on human specimens to ensure the reliability of test results regardless of where the test is performed.

Quidel has announced the launch of QuickVue in Italy, Germany, and the United Kingdom. The test is important, says Quidel, because it may help people avoid unnecessary medications, including antibiotics, while prompt diagnosis of the flu will allow for prompt treatment with antiviral drugs. In addition, an accurate diagnosis is important because a number of flu-like symptoms can be indicative of other illnesses that may be potentially more serious.



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