The FDA's ability to issue Emergency Use Authorizations isn't limited to treatments; the administration can also hand them out for medical equipment and tests. And today, it approved the first over-the-counter, at-home SARS-CoV-2 test kit. The kit detects the presence of a protein found on the surface of the virus and sends the results to a user's smartphone via a Bluetooth connection. While it's less accurate than the diagnostic approaches used by large testing centers, the FDA cited an accuracy of over 90 percent when issuing the authorization.
This isn't the first at-home test kit given approval by the FDA. In November, the FDA issued an Emergency Use Authorization to a company called Lucira, which is offering a test that requires a prescription. Lucira's test is based on sensing the virus' genetic material, using a series of enzyme-catalyzed reactions that work at room temperature.
The new test comes from a company called Ellume and is based on identifying the presence of one of the virus' proteins. Typically, these tests rely on the use of antibodies to the protein, typically linked to a chemical that can induce a color change; Ellume tags its antibodies with fluorescent quantum dots. The sample—in Ellume's case, a swab of material from the nose—flows across the device while mixing with antibodies, producing a change in color at a specific location on the device.
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