Rapid Flu Test Approved by FDA

A second-generation influenza A and B infection test for children and adults with the ability to report a positive result in 5 minutes, has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA).

According to previous research rapid diagnostics with increased sensitivity are essential for the reliable detection of influenza A and B, enabling healthcare professionals to make immediate, effective treatment decisions and prevent unnecessary prescribing of antibiotics and antiviral medications.

Rapid diagnosis of influenza can help reduce length of hospital stays, secondary complications and the cost of hospital care, and allow effective implementation of infection control measures. 

The burden of influenza is currently estimated to be 25-50 million cases per year, causing as many as 150,000 hospitalizations annually.

The Alere i Influenza A & B 2 test also offers increased sample flexibility with nasopharyngeal swabs now validated for direct use, as well as in transport media.

"With this latest enhancement we now can offer 'early call out' of positive results. In acute care settings, every minute counts when assessing symptomatic patients. Alere i delivers clinically meaningful and actionable results to clinicians, enabling them to treat patients more quickly and appropriately," said Avi Pelossof, Alere Global President of Infectious Disease."

The clinical performance of Alere™ i Influenza A & B 2 was established in a multi-center, prospective clinical study conducted at ten US trial sites during the 2016-2017 respiratory season, in which 1074 prospective nasal or nasopharyngeal swab specimens, collected from patients with influenza-like symptoms, were evaluated with Alere™ i, and compared to an FDA-cleared real-time Polymerase Chain Reaction (RT-PCR) test.

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014, with Alere i Strep A receiving FDA clearance in March 2015 and Alere i RSV receiving clearance in October 2016. The Alere i Influenza A & B 2 test will be available for use in hospitals in time for the 2017-2018 respiratory season.

For the 2017–18 season, the Centers for Disease Control and Prevention (CDC) says the quadrivalent and trivalent influenza vaccines will be available.

Inactivated influenza vaccines (IIVs) will be available in trivalent (IIV3) and quadrivalent (IIV4) formulations. Recombinant influenza vaccine (RIV) will be available in trivalent (RIV3) and quadrivalent (RIV4) formulations.

Live attenuated influenza vaccine (LAIV4) is not recommended for use during the 2017–18 season due to concerns about its effectiveness against (H1N1)pdm09 viruses during the 2013–14 and 2015–16 seasons.

The CDC recommends that any pregnant woman who has questions about vaccines talk to her healthcare provider.

The CDC does not offer preferential recommendation for one influenza vaccine product over another. Most pharmacies offer several flu vaccines.

The cost varies depending upon your insurance and which state you live. The CDC Vaccine Price List provides the private sector vaccine prices for general information.

Vaccine discounts can be found here.

For more information on Alere i Influenza A & B 2, go to www.alere.com.