FDA Grants Emergency Use Authorization for COVID-19 Serology Test

FDA recently issued an Emergency Use Authorization (EUA) for Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. 

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This authorization is 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.

The company expects to ship nearly 30 million antibody tests globally in May through its Architecht and Alinity i platforms. The company will have capacity for 60 million tests in June.

Antibody testing looks for antibodies to the virus and can help identify individuals who have developed an adaptive immune response. Data shows reliable results with 99.6 percent specificity and 100 percent sensitivity for patients tested 14 days after symptoms began.

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."

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.

“Abbott's Alinity family of harmonized solutions is unprecedented in the diagnostics industry, working together to address the challenges of using multiple diagnostic platforms and simplifying diagnostic testing. Alinity systems are designed to be more efficient – running more tests in less space and minimizing human errors – while continuing to provide quality results,” the company stated.

Abbott expects to submit for CE Mark for its Alinity i SARS-CoV-2 IgG test this week and will initiate global shipments immediately.

Experts believe that if an individual develops antibodies to the novel coronavirus, they may have at least temporary immunity from reinfection, although this is still unproven and the parameters of that immunity are still unknown.

Last week, the first emergency use authorization antigen test was granted to Ouidel Corporation’s Sofia 2 SARS Antigen FIA to help disseminate the test quickly to diagnose COVID-19.

The test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver. 

The Sofia 2 SARS Antigen FIA can provide results in minutes. Antigen tests can generally be produced at a lower cost than PCR tests and have the potential to test millions of Americans per day due to a simpler design structure. 

FDA’s authorization of the antigen test came at the heels of a Roche announcement that it developed a serology test to detect antibodies in individuals who have been exposed to COVID-19.

The serology test, Elecsys, was designed to identify individuals who may have been infected by the virus but do not display any symptoms. 

Elecsys can screen essential workers who may have developed immunity, so they are able to safely return to work. The test can also be used in epidemiological research to uncover the spread of the disease in the future. 

“Timely availability and fast access to reliable, high quality tests are essential for healthcare systems. The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.” Thomas Schinecker, CEO Roche Diagnostics, said in the announcement.