FDA Clearance for QuickVue® RSV 10 Immunoassay Diagnostic Test
Quidel Corporation has received 510(k) clearance from the FDA for the sale of its QuickVue® RSV 10, a lateral flow immunoassay test for the qualitative detection of acute respiratory syncytial virus (RSV) infections.
Almost all infants will suffer from an RSV infection before the age of two. According to the United States Centers for Disease Control and Prevention, RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States resulting in between 75,000 and 125,000 children hospitalized annually because of an RSV infection.1, 2
QuickVue RSV 10 detects RSV antigen directly from nasopharyngeal swab and nasopharyngeal aspirate/wash specimens from symptomatic patients under the age of six.
'The signs of an RSV infection are often similar to other respiratory infections, and diagnosis by symptoms alone can be difficult. Our new QuickVue RSV 10 product is a reliable, easy-to-use aid in detecting RSV in children. This new product will be available for the upcoming RSV season, which normally begins in November,' said Douglas Bryant, president and chief executive officer of Quidel Corporation. 'QuickVue RSV 10 offers results in 10 minutes, which can provide a significant time savings to healthcare professionals.'
QuickVue RSV 10 employs the identical test method and sample preparation of the QuickVue® Influenza A+B test, allowing for the use of the same nasopharyngeal patient specimen when testing for influenza or an RSV infection.
1 Centers for Disease Control and Prevention website: http://www.cdc.gov/rsv/about/faq.html
2 March of Dimes website: http://www.marchofdimes.com/pnhec/298_9546.asp
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Source : Quidel Corporation View Company Information
Posted on October 5, 2010