Rapid Antigen Test For COVID-19 Authorized By FDA

Antigen testing works by scanning for proteins that can be found on or within a virus, and this is a relatively new type of test for COVID-19. The recent FDA authorization was based on a sample size of 226 specimens from sites across America, according to research notes from Evercore ISI analyst Vijay Kumar.

"We think the new antigen test will play a big role in the coming flu season as a rapid, rule out test," Kumar said.

The company has plans to produce 2 million of these tests per week until the end of September, 2020. The FDA suggests that rapid tests are an important tool for combating the pandemic as they are produced quickly at a relatively low cost and can be used in a range of settings. 

According to a release from the company:

“The BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2 Assay is deemed to be a CLIA-waived immunoassay designed to be used in health care settings to provide an aid to rapid diagnosis of COVID-19 in symptomatic individuals. BD clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity and 100% specificity, which is in line with the performance from similar immunoassay tests for Flu A/B, RSV and Strep A on the BD Veritor™ Plus System — all of which are widely-used, highly relevant and clinically valid. Similar to all immunoassay tests, FDA recommends that negative test results be confirmed by a molecular method to confirm the result, if necessary, for patient management.”

“The BD point-of-care test has not been cleared or approved by FDA. The test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid antigens to aid in the diagnosis of SARS-CoV-2 virus infection. It has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.”

This test can be used on the company’s existing BD Veritor System Platform, which is currently being employed in around 25,000 healthcare facilities across America. The company is also selling a variety of other types of testing for COVID-19, and it is ramping up testing capacity for many of them.

"This will be a game changer for frontline healthcare workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real time at convenient locations like retail pharmacies, urgent care centers, and doctors' offices," said Dave Hickey, president of Becton Dickinson's integrated diagnostic solutions business.

“This is a huge addition to the Covid fight. This rapid point of care system is accurate and has an enormous installed base. BD maintains its own supply chain end to end. Many of us were waiting for BD to get its Veritor system authorized. That day has come,” wrote Scott Gottlieb, former FDA commissioner, on Twitter.