The Food and Drug Administration (FDA) is concerned that 15-minute influenza tests are all too often unreliable and inaccurate, and could lead to a public health crisis if infected patients are told they don't have the flu when, in fact, they do.
To protect against another pandemic like the 2009 swine flu, the FDA's Microbiology Devices Panel announced this week that it is considering tightening the controls on these rapid influenza test kits to make sure they will produce accurate results.
The FDA proposed tightening rules following reports that the rapid influenza detection tests were providing doctors with inaccurate readings, particularly in 2009, when the swine flu broke out.
"The recent 2009 flu pandemic has emphasized the poor performance of the rapid influenza detection tests (RIDTs) as they were widely used by clinicians in point of care settings," the FDA wrote in Thursday's edition of the Federal Register. "At that time, FDA received informal communications from CDC and public health laboratories reporting the poor performance of these devices with anecdotal reports of many misdiagnosed cases of influenza, some with serious or fatal outcomes."
Five years later, the FDA is looking to prevent any more such misreadings.
The first rapid influenza detection test came out in 1990, the FDA noted, estimating that there are currently 12 such devices on the market.
Doctors use these devices to diagnose patients with the flu, but patients cannot use them on their own. Doctors say they are quick and convenient. However, they do present some difficulties.
"Although the poor sensitivity of RIDTs has always been a concern, they were valued for their ease of use, quick time to result and high positive predictive," the FDA wrote.
The public has 90 days to comment on the proposed rule.