FDA Clearance for QuickVue® Influenza A+B Test
Quidel has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Quidel’s CLIA Waived QuickVue® Influenza A+B assay for the rapid, differential detection of influenza types A and B.
In a recent clinical study, Quidel’s QuickVue® Influenza A+B test was shown to meet the FDA’s reclassification criteria for Class II Rapid Influenza Diagnostic Tests and is available for sale in the United States. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.
“Influenza is a highly contagious, acute, viral infection of the respiratory tract, and rapid diagnosis is critical to avoid potentially serious complications. Recent CDC figures and positivity rates from our Sofia analyzers suggest that this year’s influenza season may be getting worse, not better, and has surpassed the rate of every other year except the unusual pandemic of 2009. Quidel’s QuickVue® Influenza A+B test identifies and differentiates influenza type A and B in approximately 10 minutes aiding in better patient management decisions for healthcare professionals,” commented Douglas Bryant, president and chief executive officer of Quidel Corporation.
The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with the most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.1
1 Murphy, B.R., and R.G. Webster. Orthomyxoviruses, In: Fields Virology, 3rd edition, B.N. Fields, D.M. Knipe, P.M. Howley, et al. (eds.), Lippincott-Raven, Philadelphia. 1996, pp. 1397–1445.
Date Published: February 20, 2018
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