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Daily Chart: Roche COVID-19 antibody test joins top of the pack
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May 6, 2020 12:05 AM UTC
Updated on May 6, 2020 at 1:43 AM UTC
A COVID-19 antibody test from Roche (SIX:ROG; OTCQX:RHHBY) is the sixth serological test granted Emergency Use Authorization (EUA) by FDA to meet the agency's new sensitivity and specificity thresholds in internal validation studies. At least five other antibody tests given EUA do not meet these standards (not shown).
FDA is looking for at least 90% sensitivity/positive predictive agreement (PPA) and 95% specificity/negative predictive agreement (NPA). Roche’s test has a sensitivity/PPA value of 100% and a specificity/NPA value of 99.8%...
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