New Coronavirus Rapid Test Costing $5 Will Be Available For Emergency Use In September

On Wednesday, Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) had approved Emergency Use Authorization (EUA) for its new rapid test for detection of COVID-19; Abbot will sell the test for $5. The test will be available for use by authorized laboratories and in patient care settings.

“It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes,” Abbott wrote. “BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.”“Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™,” Abbott continued. “This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.”

Abbott stated that the test “demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, stated, “The massive scale of this test and app will allow tens of millions of people to have access to rapid 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.”

Abbott said it “will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.”

The CDC does not approve of antibody testing for COVID-19, writing:

The Food and Drug Administration has not authorized antibody testing to diagnose COVID-19, and the CDC does not currently recommend using antibody testing for diagnosis of any infection.  In certain situations, antibody tests may be used in conjunction with viral detection tests to support clinical assessment of persons who present late in their illnesses.  In addition, if a person is suspected of having a post-infectious syndrome caused by COVID-19 (e.g., Multisystem Inflammatory Syndrome in Children; MIS-C), antibody tests may be used to determine prior infection.

Antibody tests for COVID-19 can play an important role in surveillance and epidemiologic studies, which can provide insights into the transmission dynamic of the virus among the general population.  Unlike direct viral detection methods that can detect currently infected persons, antibody tests help determine whether the individual being tested was previously infected, even if that person never showed symptoms.