As the COVID-19 pandemic has spread around the globe, accurate and rapid testing for the disease has become a critical part of the fight against the spread. Currently, getting tested requires a trip to and a long wait at a clinic or a government-run testing site.
However, things could soon change for the better, as Kroger Health today announced that it is planning to obtain FDA approval for a smartphone-enabled COVID-19 rapid antigen test.
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.
Kroger Health expects the at-home rapid antigen test will be available to purchase on Kroger.com and over the counter at its 2,200 pharmacies nationwide.
To use the test, patients follow step-by-step video instructions in an app to properly collect the nasal swab and complete the rapid antigen test. After 15 minutes, the app prompts the patient to scan their rapid test. The app uses patent-pending, artificial-intelligence-based technology to provide patients with their results in seconds, helping minimize reader variability. To fulfill legal reporting requirements, the app also shares the HIPAA-compliant results with appropriate public health agencies.
The test is still awaiting FDA approval, and Kroger Health says clinical trial results submitted to the agency show the test has a “93% positive agreement and 99% negative percent agreement compared to high-sensitivity, emergency-use-authorized PCR tests.”
Kroger Health offers a variety of COVID-19 testing solutions, including viral and antibody testing. Learn more at Kroger.com/CovidCare.