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"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," Colleen Lindholz, president of Kroger Health, said in the announcement.
"We're proud to partner with Gauss to expand our COVIDCare+ suite with the forthcoming launch of this affordable, innovative solution,” Lindholz continued.
Patients will receive step-by-step video instructions through a smartphone app to properly collect the nasal swab and complete the rapid antigen test. After 15 minutes, the app will ask the patient to scan their test.
The app leverages patent-pending, artificial intelligence-based technology to give patients their test results in seconds and also shares the results with appropriate public health agencies. This helps to decrease reader variability, the companies 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," 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,” Satish continued.
The COVID-19 antigen test kit expands Kroger’s existing portfolio of coronavirus testing solutions.
Kroger has the capability to produce up to 30 million tests per month, which will be available for purchase on the company’s website and over the counter at its 2,200 pharmacies nationwide.
The test was developed by Gauss and Cellex, a biotechnology company specializing in point-of-care diagnostic testing. Just last month, Gauss produced 1.5 million tests, which will be available for distribution when the test receives FDA emergency use authorization.
Cellex was the first company to receive an FDA emergency use authorization for rapid COVID-19 antibody testing in April 2020. Since the authorization, the test has elicited 90 percent sensitivity and 100 percent specificity in clinical trials.
In mid-November, FDA issued the first emergency authorization for an at-home COVID-19 diagnostic test to the Lucira COVID-19 All-In-One Test Kit.
Just one month later, FDA authorized the first at-home influenza and COVID-19 diagnostic test intended for patients who are suspected of respiratory infection consistent with the coronavirus.
The test, Quest Diagnostics RC COVID-19 + Flu RT-PCR Test, is authorized for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 Flu when home collection is approved by an individual’s healthcare provider.
The Lucira COVID-19 All-In-One Test Kit and the Quest Diagnostic RC COVID-19 + Flu RT-PCR Test are both authorized for at-home use with self-collected nasal swab samples in individuals 14 years of age and older who are suspected of COVID-19 by their healthcare provider.
Additionally, the tests can be used in point-of-care settings, including doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages. But both tests are currently authorized for prescription use only.
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