Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
Abbott Laboratories has won Emergency Use Authorization for another COVID-19-related diagnostics test for antibodies. This morning, the company said the U.S. Food and Drug Administration approved its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
With the approval in hand, Abbott intends to shop nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have the capacity for 60 million tests in June. Today’s approval follows an April approval under EUA for its SARS-CoV-2 IgG antibody blood test on the ARCHITECT system. That test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection. Since that approval, Abbott has begun shipping antibody tests across the U.S., U.K., Italy, Spain and India.
Robert B. Ford, president and chief executive officer of Abbott, said having more options to test for antibodies is increasingly important as governments begin to look at loosening shut-down restrictions in order to reignite stagnant economies. Additionally, increased antibody testing will provide a greater understanding of the virus, including how long antibodies stay in the body and how much of the population has been infected.
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them. The regulatory agency took action after multiple tests hit the market that were flawed or did not meet standards that the agency has in place. Those tests the FDA raised concerns about had not undergone the same scrutiny as those that received EUA, such as Abbott’s tests and Roche’s serology tests. Last week, the FDA greenlit Roche’s Elecsys Anti-SARS-CoV-2 antibody test under EUA.
The Alinity i system is Abbott’s next-generation immunoassay instrument, which was designed to offer greater efficiencies to lab clinicians running tests. Alinity i systems are in use around the world in hospital and academic centers as well as reference laboratories, the company said in its announcement. A study to determine the clinical performance of Abbott’s SARS-CoV-2 IgG assay found it had greater than 99.6% specificity, meaning it had significant ability to exclude false positives. The study also showed the test had a 100% sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began.
This is Abbott’s fourth COVID-19 test to receive FDA EUA. The company intends to seek emergency approval in Europe for its latest antibody test.
“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,” Ford said in a statement.
Abbott is collaborating with leading virology labs to validate test results and is working to quickly install additional instruments to help contribute to large scale testing, the company added. Last week, Abbott announced it has shipped nearly 1.4 million of its rapid ID NOW tests across the nation and is currently manufacturing 50,000 tests per day. Abbott plans to increase this manufacturing to 2 million tests a month by June.
