Company Projects Strong Finish for 2005 SAN DIEGO--(BUSINESS WIRE)--Dec. 29, 2005--Quidel Corporation (Nasdaq:QDEL - News), a leading provider of rapid point-of-care (POC) diagnostic tests, reported today that it has obtained FDA clearance for its new and improved claims for the QuickVue® Influenza A+B test which is a 10-minute diagnostic test for influenza. Among new claims added to the package insert is 94% sensitivity for detecting Influenza A when using nasal swab specimens. The package insert for the test is being updated to include clinical study results for nasal swab, nasopharyngeal swab and nasal wash in addition to analytical study results for the detection of cultured avian influenza viruses. The QuickVue Influenza A+B test has been shown to detect cultured avian influenza viruses, including avian Influenza A subtype H5N1 virus; however, as with other rapid tests for influenza, the ability of the QuickVue Influenza A+B test to detect influenza A in patients infected with H5N1 has not been established. ADVERTISEMENT A clinical study to validate the performance of Quidel's 10-minute diagnostic test for influenza, the QuickVue Influenza A+B test, was completed in Australia during that continent's flu season from July through September 2005. The clinical data reinforce the analytical study findings from the University of Rochester Medical Center, announced on May 10, 2005, which demonstrated that the Quidel test had the highest sensitivity, 95% of the time, was the easiest to use and provided the most rapid time to result compared with competing rapid tests.(1) The Company's website, www.quidel.com, and its Influenza website, www.flutest.com, are being updated to include the new package insert, ease of use, speed to result and comparative claims data. Flu prevalence data from the Centers for Disease Control and Prevention, ("CDC") is updated weekly and can be accessed through the www.flutest.com website. Currently, the Centers for Disease Control and Prevention reports that influenza activity in the United States is increasing with visits to the sentinel providers (reporting physicians) above the national baseline.
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