FDA Approves Abbott’s $5 Covid-19 Rapid Antigen Test That Will Give Results In 15 minutes  

The US Food and Drug Administration today announced that it has issued an emergency use authorisation to Abbott Laboratories for a $5 rapid-response Covid-19 antigen test that is roughly the size of a credit card.

The emergency use authorisation was issued to Abbott for its BinaxNOW COVID-19 Ag Card. In this antigen test results can be read directly from the testing card with a similar design to some pregnancy tests. The design is fast and efficient for healthcare providers and patients and does not need the use of an analyser.

The test involves a nasal swab administered by a health-care professional such as a doctor, school nurse or pharmacist. The swab is inserted into the card-like test. After waiting 15 minutes, the healthcare provider reads the results directly from the testing card. One line indicates a negative result; two lines indicate a positive result.

The test could be administered at point-of-care settings, like a doctor’s office, emergency room or some schools.  This test has been authorised for use in patients suspected of COVID-19 by their healthcare provider within seven days of symptom onset.

FDA noted that antigen tests in general are very specific, but not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular assays, FDA advised that negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions. Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information.

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Abbott plans to make up to 50 million tests available monthly in the U.S. at the beginning of October 2020.