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ABOUT ABBOTT
Abbott Statement on First Family COVID-19 Diagnosis
We wish the President and First Lady a speedy recovery. While we don’t know the details on who was tested and on which devices, we know that more than 11 million Americans have taken the ID NOW test, helping to stop the spread of the virus. We also know from our large post-authorization study that ID NOW demonstrates performance of 95% sensitivity and 98% specificity in people within 7 days post symptom onset.
Citing data from the flawed and debunked NYU study is careless and irresponsible. Science matters. The small NYU study on ID NOW was rife with limitations, including testing methods, poor sample collection, and the inclusion of many patients who were weeks after having reported symptoms.
This story was originally published on October 02, 2020 and updated on June 03, 2022.
IMPORTANT SAFETY INFORMATION
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless theauthorization is terminated or revoked sooner.