FDA Nod For Abbott’s At-home Covid-19 Test

The U.S. Food and Drug Administration has issued a new emergency use authorization or EUA for Abbot Diagnostics’ Covid-19 home test.

The BinaxNOW COVID-19 Ag Card Home Test is now authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider.

The test is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider.

In both instances, the test can be conducted within the first seven days of symptom onset.

Abbot plans to offer the test in partnership with a telehealth service that will take users step-by-step through the sample collection process and provide assistance in reading and understanding the results. The telehealth provider will also report all test results to the relevant public health authorities in accordance with local, state, and federal requirements.

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, now said, “With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home. We will continue to work with test developers to support the availability of more innovative testing options.”

Abbott’s BinaxNOW COVID-19 Ag Card, which is a different product than the latest home use test, is already received an EUA in August for use at the point-of-care. It is the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.

According to the FDA, antigen tests are very specific for COVID-19, but are not as sensitive as molecular PCR tests. This means that there is a higher chance of false negatives than with many molecular tests.

This week, the FDA issued an EUA to Ellume COVID-19 Home Test, developed by Australian company Ellume Limited, which is the first non-prescription Covid-19 test, that can be taken fully at home and provides results within 20 minutes.

Since the start of the pandemic, the FDA has authorized more than 225 Covid-19 diagnostic tests including more than 25 tests in which swab samples can be collected at home and then send to a lab for testing.

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