What you need to know
- A US firm says its smartphone-enabled COVID-19 test is currently awaiting FDA approval.
- The test can be done at home with just a smartphone and a lateral flow test.
Cincinnati firm The Kroger Co says it is awaiting emergency FDA approval for the first-ever smartphone-enable COVID-19 test.
In a press release the company stated:
Kroger Health, the health care division of The Kroger Co. (NYSE: KR), today announced plans to offer the first smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit to patients nationwide, expanding the company's existing portfolio of in-clinic and employer-focused COVID-19 testing solutions.
The new at-home testing solution, which is currently awaiting Food and Drug Administration (FDA) Emergency Use Authorization (EUA), will offer affordable access to cutting-edge testing technology developed by Gauss, a leader in computer vision-aided healthcare diagnostics. Once authorized, it will be the first rapid COVID-19 test that can be fully performed using only a smartphone and a lateral flow assay (similar to an at-home pregnancy test), without involving a laboratory, a telemedicine visit or any specialized electronics. Last month, Gauss produced its first 1.5 million tests, which will be available for immediate distribution when the test receives EUA from the FDA, and the company has the capability to produce up to 30 million tests per month.
The test, which will be available from Kroger's website and its 2,200 pharmacies, comes with step-by-step video instructions in-app, showing users how to collect a nasal swab and complete the included rapid antigen test. After 15 minutes, users are prompted to scan their rapid test using "patent-pending, artificial-intelligence-based technology to provide patients with their results in seconds." The smartphone element of the test is designed to minimize reader variability, and shares the results with "the appropriate public health agencies." To be clear, the test itself is still done using a regular lateral flow test. Seemingly, the smartphone is there only to confirm the result given by the test to prevent people from misreading their results.
The test has been developed by Gauss and Cellex, using an "encrypted, easy-to-use smartphone app". The test reportedly demonstrates a 93% positive agreement and 99% agreement "compared to high-sensitivity, emergency-use-authorized PCR tests."
You can read the full release here.