FDA Authorizes First COVID-19 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 has been authorized by the FDA, 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 Lucira COVID-19 All-In-One Test Kit will be limited to patients at Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Fort Lauderdale until next spring.
Individuals must have symptoms and a health provider's referral to get the test since it is currently authorized for prescription use only.
Lucira - home coronavirus test will cost about $50 and deliver results in 30 minutes or less.