Traditionally, the US FDA and other major medical/regulatory bodies in the US have taken a conservative approach to authorizing at-home over-the-counter rapid tests — that is, tests that can be acquired without a prescription and which can performed entirely at home in an unsupervised manner and within a short time span (usually, about 10-25 minutes). The Institute for Progress said the following in January 2022 (at the peak of the Omicron wave) about the issue with FDA's conservative approach:

The United States doesn’t have enough rapid tests. The root cause of this shortage is that the Food and Drug Administration (FDA) doesn’t have an appropriate framework for thinking about tradeoffs during an emergency ... Rapid tests provide a key example of where the FDA has treated clinical trial data as necessary when other data should be sufficient for authorization during a public health emergency. Despite the broad benefit to the public of having rapid tests widely available, their supposed individual inferiority to PCR has kept almost all of them off the market.

As of June 14, 2022, there are 20 at-home over-the-counter rapid tests for SARS-CoV-2 that have been authorized by FDA. However, to date there are no at-home over-the-counter rapid tests for influenza that have been authorized by FDA. A recent study on such a test found encouraging results: "sensitivity and specificity of the self-test were comparable with those of .... clinical settings ... deployment of home tests may provide a valuable tool to support the management of influenza."

The purpose of this question is to understand the potential for the US FDA to authorize an at-home over-the-counter rapid test for influenza. Such a test may play a key role in helping to reduce transmission of seasonal influenza and, critically, can play an important role from the very start of any potential future flu pandemics.

Before 2025, will the US FDA authorize use of an at-home over-the-counter rapid test for influenza?

This question will resolve as Yes if the US FDA authorizes an at-home over-the-counter rapid test against influenza at any point before January 1, 2025. Any kind of authorization, including emergency use authorization, will be sufficient for this question.

Such a test must meet the following requirements for this question:

• be able to detect both influenzas A and B

• at-home, meaning the entirety of the testing process (collecting of sample, performing the test, reading of result) can be done at home without need for supervision or for anything to be sent to a laboratory

• over-the-counter, meaning a prescription is not needed

• rapid, meaning it quickly tests for influenza and does not take longer than 30 minutes

No additional requirements (such as accuracy, cost, or supply) are necessary for resolution.