The FDA has approved an emergency use authorization for at-home testing for Covid-19 using the Lucira COVID-19 All-In-One Test Kit with a prescription.

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for self-testing at home for COVID-19 to ensure a rapid, accurate diagnostic test for self-testing at home. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

The Lucira COVID-19 All-In-One Test Kit test offers self-collected nasal swab samples intended for use for individuals aged 14 and older. It also is authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages. Samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only. 

The test works by swirling the self-collected sample swab in a vial, which is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2. Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and health care provider instructions for reporting.

For more information, download the FDA’s press release or visit Lucira’s website.