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FDA clears Quidel's flu-test kit

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Published: Dec. 29, 2005 at 3:58 PM

SAN DIEGO, Dec. 29 (UPI) -- Quidel said Thursday that it has been OK'd to market its rapid test for detecting influenza types A and B.

Quidel said the Food and Drug Administration has cleared its QuickVue Influenza A (plus) B test, which the firm said can detect the flu virus in 10 minutes.

Quidel said it has been approved to add a new claim to the product's package insert that the test is 94-percent effective for detecting the two flu-virus subtypes using nasal-swab specimens, as well as study data on the test's ability to pick up cultured avian-flu virus.

Quidel said its QuickVue test has been shown to detect cultured avian-influenza viruses, including subtype H5N1, but the test's capability in detecting H5N1 in patients has not been established.

The test's updated labeling will also include clinical study results for nasal swab, nasopharyngeal swab and nasal wash, the company said.

© 2005 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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