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FDA Grants EUA For Roche’s Coronavirus Antibody Test

 
• By Phil Greenfield

The company says the serology test has a specificity of 99.8% and sensitivity of 100%

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Roche Diagnostics Corp.'s Elecsys Anti-SARS-CoV-2 antibody test has been granted US Food and Drug Administration emergency use authorization and is now available in all markets accepting the CE mark.

The company said that based on a study of nearly 5,300 samples, the serology test, for immunoglobulin G (IgG) antibodies, has a specificity of 99.8%. The test also has a sensitivity of 100% some 14 days after infection has been confirmed by polymerase chain reaction (PCR) testing

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