The Food and Drug Administration has issued Emergency Use Authorization for Abbott’s AdviseDx SARS-CoV-2 IgM (immunoglobulin M) lab-based serology test for use on the Architect and Alinity platforms.

CHICAGO (NewsNation Now) — The U.S. Food and Drug Administration (FDA) issued an emergency use approval for Abbott’s latest lab-based COVID-19 IgM antibody test, the company announced Monday. Abbott ...

"Our new SARS-CoV-2 IgM assay provides information about an individual's immune status with a positive predictive value of 95.5% in a population with disease incidence as low as 3%," said Julie Sawyer ...

The current COVID-19 pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a betacoronavirus that causes severe acute respiratory distress in a significant proportion of ...

The COVID-19 pandemic, which was caused by SARS-CoV-2, has had a significant effect on global public health, economies, and societies worldwide. Serum antibody testing is a critical method for the ...

EXTON, Pa., May 24, 2021 /PRNewswire-PRWeb/ — Megna Health, a U.S. manufacturer of Rapid COVID Tests based in Exton, Pennsylvania, announced that it has filed a U.S. Food and Drug Administration (FDA) ...

(RTTNews) - Abbott (ABT) announced the FDA has issued Emergency Use Authorization for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT and ...

HIGH WYCOMBE, England, Nov. 10, 2020 /PRNewswire/ -- Beckman Coulter, a clinical diagnostics leader, today announced the launch of its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in countries ...