FDA grants Abbott's COVID-19 rapid antigen test emergency-use authorization

By Angela Betsaida B. Laguipo, BSNAug 27 2020

One of the most effective ways to contain the spread of the coronavirus disease is to identify those who are infected immediately. This way, isolation of active cases and contact tracing can be performed quickly before the virus could spread to others.

There are two tests used to detect the presence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the coronavirus disease (COVID-19). Molecular tests, such as the real-time reverse transcription-polymerase chain reaction (rRT-PCR) test, which detects the virus's genetic material, and the antigen test that detects specific proteins on the surface of the virus.

Now, the U.S. Food and Drug Administration has granted emergency-use authorization to Abbott Laboratories for a $5 rapid-response COVID-19 antigen test, called BinaxNOW COVID-19 Ag Card, which is roughly the size of a credit card.

Low-cost and portable test kit

The new test is low cost and provides a rapid response, which can be used in a doctor's clinic. It uses a lateral flow technology that is akin to home pregnancy tests and provides the results in about 15 minutes. The test kit is portable and affordable, unlike other tests available today. The new test is an important tool in detecting infectious people so they could not spread the virus to others.

"In this critical moment in the pandemic, testing is fundamental in our ability to help facilitate a return to work, school, and life with a bit more confidence. BinaxNOW™ is a fast, reliable, affordable, and portable rapid test that Abbott will produce at mass scale to expand access to testing to people who need it greatly. We'll ship tens of millions of tests in September, ramping production to 50 million tests a month in October," Abbott said on its website.

Apart from the portable rapid test kit, Abbott also plans to launch a phone app, called Navica mobile app, that will allow people who test negative to have a temporary digital health pass that can be renewed every time a person is tested through their healthcare provider.

"We're pairing this $5, 15-minute, easy-to-use test with a mobile app, called Navica, which works like a secure digital "boarding pass" that can be scanned to enter organizations and other places where people gather. This combination is life-changing technology that will attack the pandemic on critical fronts – speed, simplicity, affordability, access, and reliability," it added.

The company has yet to release its distribution strategy, and it is unclear where the tests will be sent or when they will become available.

Sensitivity rate

Other rapid antigen tests granted emergency-use authorizations by the FDA usually come in cartridges that are studied by boxlike machines. These tests cost about $15 to $50, but for people with symptoms, these tests are usually free.

Currently, there is a high demand for rapid antigen tests, and manufacturers are unable to cope with high orders. Abbot said its evidence shows that the new rapid antigen test has exhibited sensitivity, which is the percent of positive cases a test accurately detects. It has a sensitivity rate of 97 percent, contrary to previous reports that rapid tests are through to be less sensitive than lab-based PCR tests.

The company said it is ramping up production of the new tests, and the massive scale of the test and app will allow tens of millions of people to have access to fast and reliable testing.

"With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine, so they don't spread the virus," Joseph Petrosino, professor, and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, said.

Meanwhile, the BinaxNOW COVID-19 Ag Card is now for use by healthcare professionals, including doctors, nurses, school nurses, technicians, and medical assistants, among others.

It is estimated that Abbott will ship tens of millions of the tests in September, increasing to 50 million tests a month starting in October.