Kroger Health announced Feb. 16 plans to offer the smartphone-enabled, at-home Gauss COVID-19 Rapid Antigen Test Kit 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 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration, uses 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 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, and the company has the capability to produce up to 30 million tests per month, it said.
Kroger Health, the healthcare division of Cincinnati-based Kroger, 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.
"Since the start of the COVID-19 pandemic, Kroger Heath has remained committed to helping people live healthier lives by offering a variety of COVID-19 testing solutions supported by our multidisciplinary team of licensed, trained and experienced healthcare providers," said Colleen Lindholz, president of Kroger Health, in a release. "We're proud to partner with Gauss to expand our COVIDCare+ suite with the forthcoming launch of this affordable, innovative solution."
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 consumer-friendly app seamlessly also shares the reliable, secure and HIPAA-compliant results with appropriate public health agencies.
"Public health leaders agree that people need access to on-demand, reliable, rapid testing in their own homes, and that's exactly what our test delivers," said Siddarth Satish, founder and CEO of Menlo Park, Calif.-based Gauss. "As a trusted resource for COVID-19 related solutions with a broad national footprint, Kroger Health is an ideal partner to dramatically expand access for millions of Americans through our smartphone-powered, at-home COVID-19 rapid antigen test."
According to results of a clinical trial submitted to the FDA in support of the solutions EUA application, the testing solution, developed by Gauss and Cellex Inc., a biotechnology company specializing in rapid diagnostics, had a 93% positive agreement and 99% negative agreement compared to high-sensitivity, emergency-use-authorized PCR tests.
Kroger Health, which has more than 2,200 pharmacies and 220 clinics in 35 states, offers a variety of COVID-19 testing solutions, including viral and antibody testing.