Article Reports Results from Independent Study Demonstrating Test's 100% Sensitivity and Specificity for IgM Antibodies and 96.7% and 97.5% Sensitivity and Specificity, Respectively, for IgG ...
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 analysis included results from 2 tests that have received EUA: the SARS-CoV-2 ELISA test (Euroimmun) and the COVID-19 IgG/IgM Rapid Test Cassette (Healgen). The Food and Drug Administration (FDA) ...
"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 ...
WASHINGTON -- U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work. The Food and Drug Administration on Thursday ...
Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The U.S. Food and Drug Administration has granted Cellex an emergency use authorization to market a ...
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