US FDA authorises first COVID-19 antigen test where results can be read directly from testing card
The US Food and Drug Administration issued an emergency use authorisation (EUA) for the first antigen test where results can be read directly from the testing card, 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.
“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, Director Center for Devices and Radiological Health, US FDA.
The agency release cautioned that though in general, antigen tests are very specific, they are not as sensitive as molecular tests. Due to the potential for decreased sensitivity compared to molecular assays, 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.
The emergency use authorisation was issued to Abbott Diagnostics Scarborough, Inc for its BinaxNOW COVID-19 Ag Card.
How it works
A healthcare provider swabs the patient’s nose and twirls that sample on a test card with a testing reagent added. 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.
Where it can be used
This test could be used 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. Given the simple nature of this test, it is likely that these tests could be made broadly available. According to the release, Abbott plans to make up to 50 million tests available monthly in the US at the beginning of October 2020.