Today, more than 14 million cases of COVID-19 infections have been confirmed, and about 288,906 Americans have succumbed to the virus. With the infection rates hitting a new high every day, it’s good news that the FDA has approved the first COVID-19 diagnostic test kit for at-home self-testing. Through an emergency use authorization (EUA), the U.S. Food and Drugs Administration gave a nod of approval to the Lucira COVID-19 All-In-One-Test Kit. This COVID-19 test kit is a molecular single-use test designed to detect SARS-CoV-2, the novel coronavirus that causes COVID -19.
FDA’s Commitment to Facilitate Rapid COVID-19 testing
The approval of the Lucira COVID-19 All-In-One Test Kit test underlines the FDA’s commitment to expanding mass access to COVID-19 self-testing. FDA Commissioner Stephen M. Hahn, M.D., says that the Lucira at-home Coronavirus test kit is the first test-kit that fully supports self-testing and delivers rapid results at home. The commissioner says that the FDA’s approval of the Lucira COVID -19 test kit is a significant diagnostic development that will help curb the pandemic by reducing the rate of Coronavirus transmission in public. Given that about 80% of people who get COVID-19 recover without special treatment, easy access to Coronavirus test kits will enable many people to test for the virus. As such, people with positive results will self-isolate and seek medical care, while those with negative results will take the necessary precautions to avoid catching the virus.
Who Has Access to The Lucira COVID-19 All In One Test Kits?
The Lucira at-home COVID-19 Test Kits have been authorized for home use for individuals aged 14 and above who have been suspected of catching COVID-19 by their healthcare provider. Individuals below 14 years can also receive the COVID-19 test kit, but a healthcare provider must collect the nasal swab samples. The Lucira Coronavirus test kit is authorized for prescription use in point-of-care locations, such as urgent care centers, emergency room, hospitals, and doctors’ clinics.
How Does the Test Work?
First, individuals must collect a nasal swab sample by inserting the swab to the length of an inch in each nostril and rotating the swab about five times. The sample swab is then swirled in a vial, which is well-placed in the test kit, starting the diagnostic process. In under 30 minutes, the results of the COVID test can be read from the test kit. The test kit is well labeled to indicate positive or negative results. A green light will display on the positive or negative label after the test is done.
A positive COVID result takes about 11 minutes, while a negative result takes about 30 minutes. People who get a negative result and still experience COVID-like symptoms should seek additional medical attention from their healthcare provider. When people take the test too early in the incubation period, the COVID results may turn out negative while the SARS-CoV-2 virus has already infected a person. The ideal time to take the test using coronavirus test kits for sale is a couple of days after COVID-like symptoms develop.
Efficient Tracking, Monitoring, and Reporting of Test Results
Jeff Shuren, M.D., J.D., the FDA’s Center for Devices and Radiological Health Director, says that a complete at-home COVID-19 test kit is crucial to fighting the pandemic. The FDA has prioritized out-of-lab testing to enable more Americans to take the test and take precautionary measures based on the results. All prescribing healthcare providers must report all COVID results from individuals to the relevant public health authorities as stipulated by local, state, and federal regulations. The Lucira COVID-19 All-In-One Test Kit test is well-labeled, has quick-reference instructions for individuals, and provides detailed instructions for healthcare providers to report and submit results.
The approval of the Lucira COVID-19 All-In-One Test Kit test is a big step towards taming the novel Coronavirus. Individuals aged 14 and above can access the COVID-19 test kit, take the test independently, and receive COVID results in 30 minutes or less. Ultimately, this will increase public awareness, and more people will be proactive in the fight against the pandemic.