Serology tests, also called antibody tests, help to identify people who have had a past infection with SARS-CoV-2, the virus that causes COVID-19 disease. Hundreds of these tests have been developed ...
OAKDALE, Minn.--(BUSINESS WIRE)--Infectolab Americas, an infectious disease testing laboratory from Oakdale in Minnesota, has validated a novel serology test for COVID-19. The United States still ...
Autoantibody assays may have significant differences due to the heterogeneity of autoantibodies, including epitope specificity, isotype, and affinity/avidity. This makes it challenging for clinical ...
As more and more COVID-19 data are collected, the clearer our picture of the novel disease becomes. One of the most important pieces of the puzzle (though we stress that it is nevertheless only one ...
On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous ...
Maintaining consistent assay performance over time is critical for clinical laboratories. While assay performance characteristics may be clearly understood at the time of validation, variations can ...