Fisher Healthcare Flu Testing Solutions
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Flu Season News
The Alere™ Influenza A&B Test (Cat. No: 23-046-821) is temporarily unavailable for sale.
The FDA updated its requirements for antigen-based rapid influenza detection tests on June 18, 2018. Until the Alere Influenza A&B Test is approved using the new criteria, Abbott and their distributors may not sell the product.
On January 12, 2017, the FDA formally announced that antigen-based rapid influenza detection tests were being reclassified. This change was first recommended in 2013 based on the poor performance of some existing diagnostic test products (which led to misdiagnoses) along with the introduction of newer, more-accurate technologies.
What You Need to Know
- Rapid Antigen Influenza tests have been reclassified from Class I to Class II medical devices.
- Tests now have minimum performance requirements as compared to viral culture or molecular methods.
- The special controls (test panel) will require annual and emergency analytical reactivity testing to ensure continued performance monitoring.
- The FDA will collaborate with the Centers for Disease Control and Prevention (CDC) to ensure that an influenza virus analytical reactivity test panel is available to all test manufacturers.
Webinar: Meeting the Standards of Flu Testing
Join Sally Hojvat, PhD, as she discusses the FDA flu test reclassification and how our knowledge of the flu has advanced over the past 100 years.
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Using an analyzer to read and interpret test results delivers more objective evaluations, and the ability to electronically transmit results can eliminate manual transcription errors.
Instrument-Based Molecular Tests
Molecular testing yields higher sensitivity and specificity for detecting influenza, which can reduce false-positive and false-negative results and can differentiate between virus subtypes.