A new study by researchers at New York University has found that a COVID-19 rapid diagnostic made by Abbott (NYSE:ABT) missed up to 48% of positive results, renewing questions about its accuracy. This is the same test and lab equipment used at the White House, according to published reports.
The study, conducted at NYU’s Langone Tisch Hospital, compared the Abbot ID NOW COVID-19 and Cepheid Xpert Xpress SARS-CoV-2 molecular diagnostic tests using nasopharyngeal swabs transported in a viral transport medium as well as dry nasal swabs for the Abbott assay. Abbott advised customers on April 15 that ID NOW was not designed for use with viral transport media.
Regardless of method of collection and sample type, Abbot ID NOW COVID-19 missed a third of the samples detected positive by Cepheid Xpert Xpress when using nasal swabs in a transport medium and more than 48% when using dry nasal swabs, according to the NYU researchers.
The study appeared on bioRxiv.org and has not been peer-reviewed or accepted for publication by a medical journal. In it, the researchers said they were looking for a quicker testing method for patients suspected of having COVID-19 and decided to try the Abbott ID NOW test and its associated testing device, which the company has said can produce positive results within 5 to 13 minutes and negative results within 13 minutes.
Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio. Abbott objected to the methodology used by NYU Langone Health researchers.
“Once again, a study has been conducted using ID NOW in a manner that it’s not intended to be used,” Abbott spokesperson Darcy Ross told MassDevice. “It’s unclear if the samples were tested correctly and we’re further evaluating these results. The outcomes in this paper are inconsistent with any experience that we’ve had with this instrument.”
Abbott has distributed about 1.8 million ID NOW tests and the reported rate of false negatives is at 0.02%, which has been shared with the FDA, according to the company.
“The test is performing as expected when it’s used correctly,” Ross added. “ID NOW is an important tool that delivers information where it’s needed most — taking the fight to the frontlines so that public health officials and healthcare providers can make critical decisions. Customers most familiar with ID NOW continue to demonstrate their confidence in the system.”