FDA gives emergency use authorisation for SARS-CoV-2 IgG test for COVID-19 diagnostics.- Abbott

Abbott announced that the FDA issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June.

Data shows reliable results with 99.6% specificity and 100% sensitivity for patients tested 14 days after symptoms began. Abbott expects to submit for CE Mark for its Alinity i SARS-CoV-2 IgG test in the next week and will initiate global shipments immediately.