FDA warns that Abbot's rapid COVID-19 can return false negatives; Abbot claims test is being used improperly, launching new accuracy studies

Matthew Herper / STAT
Link to story

Context

FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test May 2020 – FDA Release
Unreviewed NYU study shows Abbot’s rapid coronavirus test missed between 33% – 48% of positive cases May 2020 – Bloomberg
Following EUA for new antibody test, Abbot Labs expanding production capacity for coronavirus testing to 60 million per month starting in June May 2020 – Forbes
Abbott Labs Rolling Out Coronavirus Antibody Tests; Plans to ship 4 million tests by end of April April 2020 – Forbes
Trump Touted Abbott’s Quick COVID-19 Test. HHS Document Shows Only 5,500 Are On Way For Entire U.S. April 2020 – Kaiser Health News

Discussion

New study shows that the Abbot ID NOW #COVID19 test missed a third of the samples detected positive by Cepheid's Xpert Xpress (GeneXpert) when using nasopharyngeal swabs transported in viral transport media and more than 48% when using dry nasal swabs. https://t.co/kOCQIku5MP
— Scott Gottlieb, MD (@ScottGottliebMD) May 13, 2020