Through its Kroger Health arm, The Kroger Co. plans to offer what it called the first smartphone-enabled, at-home rapid antigen test for COVID-19.
Kroger said Tuesday that the Gauss COVID-19 Rapid Antigen Test Kit, awaiting Food and Drug Administration emergency use authorization (EUA), can be performed using a smartphone and a lateral flow assay — similar to an at-home pregnancy test — without involving a laboratory, a telemedicine visit or specialized electronics. The Cincinnati-based food and drug retailer expects the at-home rapid antigen test, once granted EUA from the FDA, to become available for purchase on Kroger.com and over the counter at its 2,200 pharmacies nationwide.
The Gauss COVID-19 rapid antigen test can be conducted using a smartphone and a lateral flow assay (similar to an at-home pregnancy test) without involving a lab, a telehealth visit or specialized electronics. (Photo courtesy of Kroger)
Gauss, a specialist in computer vision-aided health diagnostics, produced its first 1.5 million tests in January, and the Menlo Park, Calif.-based company can produce up to 30 million tests per month, Kroger reported.
“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 multi-disciplinary team of licensed, trained and experienced health care providers,” Kroger Health President Colleen Lindholz said in a statement. “We’re proud to partner with Gauss to expand our COVIDCare+ [coronavirus test] suite with the forthcoming launch of this affordable, innovative solution.”
To use the test, developed by Gauss and biotechnology firm Cellex, patients follow video instructions in an app to collect the nasal swab and complete the rapid antigen test. After 15 minutes, the app prompts patients to scan their rapid test. Via artificial intelligence-based technology, the tool provides patients with their results in seconds, helping minimize reader variability, according to Kroger. And to meet legal reporting requirements, the app shares the reliable, secure and HIPAA-compliant results with public health agencies.
According to results of a clinical trial submitted to the FDA in support of the solution’s EUA application, the test demonstrated a 93% positive agreement and 99% negative agreement versus high-sensitivity, emergency-use-authorized PCR tests, Kroger said.
“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,” stated Siddarth Satish, founder and CEO of 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.”
While both the rapid antigen and more common molecular PCR (viral) coronavirus tests employ nasal or nasalpharyngeal swabs, the latter is considered the “gold standard” in COVID-19 detection. The rapid antigen test delivers results quickly. But false positives can occur, and negative results may need to be confirmed with a molecular test, according to the Food and Drug Administration. Results can take up to a week for the molecular PCR test, yet it’s typically highly accurate and usually doesn’t need to be repeated, the FDA said.
Kroger Health offers a variety of COVID-19 testing solutions, including viral and antibody testing. Designed for employers and launched in August, COVIDCare+ comprises Kroger Health’s FDA-authorized COVID-19 Test Home Collection Kit, which became available in July, and access to clinical services for primary health and wellness care. Viral, rapid antigen and rapid antibody testing also is available at Kroger Co. pharmacies and The Little Clinic in-store clinics. Kroger rolled out rapid antibody testing to all pharmacies and clinics starting last fall. Rapid antibody testing informs patients if they previously have been infected with SARS-CoV-2, the virus that causes COVID-19.
Kroger also said on its website that it currently has a limited supply of COVID-19 vaccines available in 20 of the 35 states where it operates stores, as well as in the District of Columbia.