First Smartphone Enabled COVID-19 Rapid Antigen Test Awaits FDA Approval

Accurate and rapid COVID-19 testing has become a critical hallmark in the battle against the pandemic. Unfortunately, getting tested on a mainstream level currently requires a trip to a clinic or government instituted site.

However, in a possible breakthrough of what it means to get tested, Kroger Health today announced it’s planning to obtain FDA approval for the first smartphone-enabled COVID-19 rapid antigen test.


According to a press release, patients will administer a nasal swab themselves and complete a rapid antigen test. Then, patients will scan the rapid test using the app on their iPhone, and using AI technology, the app will provide their results “within seconds.”

What the app aims to do is remove any doubt of the actual results of the test by using AI to correctly determine the location of the results line. In COVID-19 rapid antigen tests, the presence and location of a line in different areas determines whether the patient tests positive or negative for COVID-19, and some patients may misinterpret the lines, leading to a false understanding of what their result actually is.

In compliance with the law, the app will automatically share the results with appropriate public health agencies and abides by all HIPAA rules and regulations. The hope is that this new test will increase the number of people who can get tested for COVID-19 themselves with a higher level of accuracy.

The smartphone-enabled rapid antigen test has not been approved by the FDA, however, clinical trial results have been submitted for approval and show a “93% positive agreement and 99% negative percent agreement compared to high-sensitivity, emergency-use-authorized PCR tests,” according to Kroger Health.

You can learn more about the test here.

This article, “First Smartphone Enabled COVID-19 Rapid Antigen Test Awaits FDA Approval” first appeared on MacRumors.com

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