Pandemic news has been so dominated in the past week by reports of skyrocketing COVID-19 numbers and prospective vaccines that another important breakthrough on the coronavirus front has been somewhat overlooked.
Last week the U.S. Food and Drug Administration issued an emergency use authorization for the first COVID-19 diagnostic test for self-testing at home that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic,” said FDA Commissioner Stephen M. Hahn. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first test that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The new Lucira test kit works by swirling the self-collected nasal swab samples in a vial that has been placed in the kit. 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. Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and healthcare provider instructions to assist with reporting.
The single-use test has been authorized for those 14 years of age and older who are suspected of being infected with the virus. A prescription is required, for a couple of reasons. First, users must report all test results to their prescribing healthcare providers, who must then notify relevant public health authorities. Second, the new test will take some time to fully roll out so healthcare personnel should only prescribe it at this time to people with a high likelihood of being infected with the coronavirus.
Just like the anticipated vaccines, it will be a while before the new test is widely available. Lucira said they will first be introduced in California and Florida and will be widely available nationwide in the spring of 2021. The cost of each singe-use test will be $50.
The test is also authorized for use at point-of-care settings such as doctors’ offices and hospitals, but the swabs must be collected by a healthcare provider in those facilities.
There are already FDA-approved self-testing-at-home tests available on the market. For example, in September the Albertsons supermarket chain, of which Acme Markets is a subsidiary, partnered with the New York City-based genomics firm Phosphorus to begin offering FDA-approved at-home COVID-19 tests in selected markets. The Tuckerton Acme is one of them.
The Phosphorus test is a saliva test.
“Customers appreciate the convenience and innovation of taking the test from their own home,” said Dan Salemi, general vice president of Albertsons Pharmacy. “The saliva test is easy to use and comfortable. Patients are never more than a phone call away from our pharmacy’s guidance and care. And the at-home model can help ease the burden on a stressed healthcare system.”
To get a test kit at the Tuckerton Acme, those interested first have to log on to scheduletest.com. They will be asked to make an appointment for picking up the test at the store or can alternatively have it mailed or delivered. Simple instructions explain how to collect the saliva sample. Then they send the kit to the lab (located in Secaucus) in the kit’s prepaid shipping envelope by dropping it off in a FedEx drop box or by calling 1-800-463-3339 for same-day pickup. Results will be delivered to test takers via text or email within 72 hours of the lab receiving the sample.
Price could scare customers off of the Albertsons test. It costs $139, or $149 if delivered.
Walmart is apparently looking to undercut that price. NowDiagnostics Inc. of Springdale, Ark., is developing not one, but two at-home COVID-19 tests that would use a person’s saliva and deliver results in a matter of minutes. One is an antigen test that can diagnose for active infections while the other is an antibody test that signals a previous infection. The company is backed, in part, by the Walton family that controls Walmart. The hope is to develop at-home tests that can sell for as little as $10.