What You Should Know:
– FDA approves emergency use authorization (EUA) for Lucira Health’s all-in-one-test kit for COVID-19 self-testing at home.
– The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes.
On late Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. 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.
Why It Matters
By current national estimates, up to 50 to 100 million COVID-19 tests may need to be conducted each month in the United States, with as many as 900 million totals possible through 2021. If all U.S. airline passengers were also tested, that would require one billion tests annually. Likewise, if the country’s health care workers were tested weekly for a year, that would also require around one billion tests. A variety of tests have been developed to help meet this need, with Lucira being the latest and first to get FDA authorization for prescription self-testing at home molecular diagnostic test.
Authorized for Prescription Use Only
The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages but 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.
How It Works
The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes. The Lucira COVID-19 All-In-One Test Kit comes with everything needed to perform a single COVID-19 test. Users open the box containing the test device, sample vial, swab, and simple instructions. Two AA batteries are inserted in the device and the sample vial is placed in the test unit.
Next, the user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial and then pressed down in the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes. For guidance on care and public health reporting, patients will report their test results to the medical office that prescribed the test
Availability
The Lucira ™COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers and is expected to cost around $50.
By the second quarter of 2021, Lucira Health plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a dedicated website to arrange a prescription and overnight delivery of the test kit, if approved. Follow-up monitoring will be available for public health reporting so people can get additional guidance and information if needed.
