CINCINNATI — Kroger Health plans to expand its portfolio of COVID-19 testing solutions with a new smartphone-enabled at-home test kit, the company said Tuesday.

The new testing solution, currently awaiting Food and Drug Administration (FDA) Emergency Use Authorization (EUA), will be the first rapid COVID-19 test that can be 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.

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.

“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 healthcare providers,” said Colleen Lindholz, president of Kroger Health. “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 simple 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.

The test, developed by Gauss and Cellex, Inc., a biotechnology company specializing in rapid diagnostics, is powered by an encrypted, HIPAA-compliant, easy-to-use smartphone app developed by Gauss’s team of clinical and technology leaders. According to results of a clinical trial submitted to the FDA in support of the solutions EUA application, the testing solution demonstrated a 93% positive agreement and 99% negative percent agreement compared to high-sensitivity, emergency-use-authorized PCR tests.

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.

“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, Gauss Founder and CEO. “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.”

Kroger Health offers a variety of COVID-19 testing solutions, including viral and antibody testing.