Kroger Applies for FDA Approval of Smartphone-based Home COVID-19 Testing Kit



Kroger COVID-19 testing kit

Research has shown that Apple Watch could be used to find and isolate people with COVID-19 symptoms up to a week before they test positive for the virus. Now, Kroger Health has announced the first at-home COVID-19 testing kit that can be used via one’s smartphone.

Kroger has already applied for Emergency Use Authorization (EUA) to the FDA (Food and Drug Administration) in the US for its Gauss testing kit. It also has around 1.5 million testing kits ready for distribution as soon as it gets the necessary approval from FDA. The company has the capacity to produce up to 30 million test kits per month.

As of now, one must visit a hospital or their nearest COVID-19 testing center to get tested for the virus. This is a risk as if the person is already infected with the virus, they could end up infecting others. Conducting tests in-home is a good alternative to this.

The at-home COVID-19 testing kit from Kroger requires users to collect their nasal swab and then scan it after about 15 minutes using an app that uses patent-pending AI-based technology to detect whether they have COVID or not. The result of the test will also be automatically shared with local 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.

Kroger says the testing kit has a “93% positive agreement and 99% negative agreement” compared to other PCR tests that have been authorized for emergency use.

 



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