FDA Grants EUA for Becton Dickinson’s Rapid COVID-19 Antigen Test

FDA recently issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antigen diagnostic test that can be used at the point of care.

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The test, Becton Dickinson (BD) Veritor System for Rapid Detection, is the second antigen test FDA authorized for the detection of SARS-CoV-2 antigens and is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, FDA said.

Therefore, the test can be used in patient care settings operated under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

“Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia. Today’s authorization is another achievement of that work,” FDA Commissioner Stephen M. Hahn, MD, said in the press release.

“Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly.”

The rapid COVID-19 antigen test can return results in two to three hours and can be used by hospitals and laboratories with a BD Max System, Becton Dickinson stated.

"The new BD COVID-19 test for the BD MAX™ System will help increase availability of these much-needed tests around the world," Dave Hickey, president of Integrated Diagnostics for BD, stated in a press release. "We continue to work towards a full portfolio of testing options to give health care workers choice and access to the right test for the right situation."

Serology tests, which include antigen tests, detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19, FDA said in a separate statement.

Serology tests could play a role in the fight against the coronavirus by helping healthcare professionals identify individuals who may have developed an immune response, the agency stressed.

Additionally, the test results can help to determine who may donate a part of their blood, which may serve as a possible treatment for those who are seriously ill from COVID-19. 

But at the beginning of May, the Subcommittee on Economic and Consumer Policy released a staff memo with preliminary findings that showed significant gaps in the Trump Administration’s handling of serological COVID-19 antibody testing.

One of the main challenges included the White House’s plans to reopen the economy. The lawmakers argued that the plans are flawed by their dependence on COVID-19 antibody tests, which face unanswered scientific questions. 

Additionally, FDA did not review any COVID-19 “rapid” antibody test kits before they went to market and cannot validate the accuracy of ones currently on market.

Other Subcommittee findings included a lack of enforcement by FDA that allowed manufacturers to make fraudulent claims about their efficacy and companies ignoring requests from HHS to voluntarily submit their tests for validation.

Despite these concerns, in mid-May, FDA issued an EUA for Abbott’s SARS-CoV-2 IgG-based serology blood test on the Alinity I system.

The Alinity i system is Abbott's next-generation immunoassay tool, which was designed to offer greater efficiencies to lab clinicians running tests. The systems are in use in hospital and academic centers as well as in laboratories around the world.

This authorization was Abbott's fourth COVID-19 test to receive FDA EUA, and helps provide hospitals across the US with broad, reliable antibody testing during the pandemic.

Last month, Abbott received FDA EUA and CE Mark for its SARS- CoV-2 IgG antibody blood test on the Architecht system. Abbott recently began shipping antibody tests for use on the Architecht systems globally including in the US, UK, Italy, Spain and India.

“Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for COVID-19,” Robert B. Ford, president and chief executive officer of Abbott, said in the announcement. “Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity.”