Because No One is Immune to the Law
November 20, 2020 - United States, FDA, COVID-19

FDA Authorizes First Full At-Home Test for the Detection of SARS-CoV-2

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On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting a nasal swab and placing it in a vial, which is then placed into a battery-operated test unit that provides results in 30 minutes or less. The test can also be conducted at the point of care, in patient care settings operating under a CLIA Certificate of Waiver, with nasal swab samples self‑collected by individuals 14 and older, or with nasal swab samples collected by a healthcare provider for individuals aged 13 and under. 

While most rapid tests authorized by FDA so far have been direct antigen tests, Lucira’s test is a molecular test utilizing real-time loop mediated amplification reaction (LAMP) technology. Molecular tests typically provide more accurate results, and Lucira’s validation studies showed a positive percent agreement (PPA) of 94%, and a negative percent agreement (NPA) of 98%. 

The test is expected to cost about $50, but news reports highlight that the test will not be broadly available until the spring. The test has other limitations as well. The test has not been validated for use with patients without signs and symptoms of COVID-19 infection, and, therefore, the intended use is limited to individuals who are suspected of having COVID-19 by their healthcare provider. 

Perhaps most significantly, the test is still prescription only, meaning it must be ordered by a healthcare provider or other authorized prescriber. Although FDA has stated on the weekly Town Halls that when a test is designated for use in a non-laboratory environment by FDA, public health reporting is not legally required, and we suspect that FDA is hesitant to authorize a true over‑the-counter test for COVID-19 due to the important public health goals served by reporting obligations. Because Lucira’s test is by prescription only, prescribing providers can follow up with patients to obtain their results and then report to public health authorities. 

This appears to be an area of concern for FDA, as Lucira’s Letter of Authorization includes, as a condition of authorization: “You must develop a mobile phone application or website to further facilitate results reporting by both the healthcare provider and the individual using your product, and submit to FDA such application or website within 4 months of the date of this letter.” Additionally, the Fact Sheet for Healthcare Providers states, “When prescribing the Lucira COVID-19 All-In-One Test Kit for at home use, please encourage patients to share test results with you as their healthcare provider by using the photo guide on the bottom of the panel of the test kit box.” FDA has encouraged developers of at-home COVID-19 tests to consider developing mobile apps connected to the test that automatically report results to public health authorities, and perhaps once that technology is available, a true over-the-counter test will be authorized.

FDA’s authorization of Lucira’s All-In-One Test Kit is certainly a step in the right direction, but there is still more to be done in the development of at-home COVID-19 tests to increase the availability and accessibility of testing nationwide. We look forward to continuing to monitor new developments in this rapidly evolving space.