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# Abbott Covid-19 Test Has High False Negatives: Study
- URL: https://www.fdaweb.com/abbott-covid-19-test-has-high-false-negatives-study/
- Published: 2020-05-14T12:00:00.000Z
- Updated: 2026-09-14T16:14:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146797

New York University (NYU) researchers say Abbott Laboratories’ ID Now Covid-19 rapid test missed a third of the samples detected positive by Cepheid’s Xpert Xpress SARS-CoV-2 test. Abbott’s test is frequently used at the White House to test visitors before entering the Oval Office. A [draft journal article ](https://www.biorxiv.org/content/10.1101/2020.05.11.089896v1.full.pdf?ref=fdaweb.com)was posted online, and FDA says it is reviewing the non-peer-reviewed research. Both tests are marketed under FDA’s emergency use authorization pathway.

The researchers say their institution was considering using the Abbott test in its emergency department and comparatively studied the devices to validate the rapid testing methodology of Abbott’s test. They write that clinical laboratories need to substantiate the clinical value and performance of Covid-19-related tests they introduce. “Accurate diagnostic testing and subsequent isolation of sick individuals is crucial to mitigating continued infectious transmission,” they write in the draft. “Therefore, assay sensitivity must be evaluated on the many newly available Covid-19 testing platforms to minimize the public health risks that come with false negative results.”

“Overall, our study revealed low sensitivity with high false negative results by Abbott ID NOW platform irrespective of use of viral transport media, which raises concern regarding the performance of the assay and its suitability as a diagnostic tool for symptomatic patients,” the researchers conclude. “The resolution could be to reflex all negative results for confirmation by a method with higher sensitivity. However, such requirement would, except for positives, severely diminish the value of the rapid results of the assay.”  

In a statement provided to ***FDA Webview*** 5/14, the company says the NYU study results are not consistent with other studies. “For example, in another recent study in Washington state, out of approximately 1,000 subjects there were 23 positive for COVID-19 on a lab test and ID NOW picked up 21, demonstrating 91% sensitivity and 100% specificity,” the company says. “We have many questions for the study authors.” Abbott says the test is deployed at more than 1,000 sites.