Kroger Health, the health care division of grocery giant Kroger Co., said Tuesday it plans to offer the first smartphone-enabled, at-home COVID-19 rapid antigen test kit in partnership with med-tech company Gauss.
The Gauss COVID-19 Rapid Antigen Test kit will expand Kroger Health’s existing portfolio of in-clinic and employer-focused COVID-19 testing solutions. The test kit is currently awaiting emergency use authorization or EUA from the U.S. Food and Drug Administration.
On FDA approval, it will be the first rapid COVID-19 test that can be fully performed using only a smartphone and a lateral flow assay. It will be similar to an at-home pregnancy test, without involving a laboratory, a telemedicine visit or any specialized electronics.
The test was developed by Gauss, a provider of computer vision-aided healthcare diagnostics, and Cellex, Inc., a biotechnology company specializing in rapid diagnostics. It is powered by an encrypted, HIPAA-compliant, easy-to-use smartphone app developed by Gauss.
Last month, Gauss produced its first 1.5 million tests, which will be available for immediate distribution once the test receives FDA approval. The company noted it has the capability to produce up to 30 million tests per month.
To use the test, patients can follow step-by-step video instructions in the app to collect the nasal swab and complete the rapid antigen test. The app prompts the patient after fifteen minutes to scan their rapid test and uses patent-pending, AI-based technology to provide the results in seconds.
To fulfil legal reporting requirements, the app will share the HIPAA-compliant results with appropriate public health agencies, Kroger Health said.
In July 2020, Kroger Health had got emergency use authorization for its COVID-19 Test Home Collection Kit. The new testing model combines at-home convenience with telehealth technology, with most results confirmed in less than 72 hours.
The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory.
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