A diagnostic test used to rapidly identify cases of the new coronavirus may be less reliable than previously thought, according to preliminary results of a study conducted by researchers at New York University.
The study’s initial findings, released on Tuesday, compared the effectiveness of two leading diagnostic assessments—one produced by Abbott Laboratories and another by Cepheid, Inc.—both previously approved for emergency use by the Food and Drug Administration. As Bloomberg reported first on Wednesday, the research showed that Abbott’s test negatively diagnosed between 30 and 48 percent of samples confirmed positive by Cepheid’s comparative evaluation. The former percentage accounts for margin of error when tests were administered using nasopharyngeal swabs, and the latter when using dry nasal swabs.
“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,” NYU’s researchers noted in their report. “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.”
Abbott’s ID NOW test has distinguished itself from others that have been authorized for emergency use by the FDA because of its rapid turnaround time between sample collection and evaluation. Whereas most quick response tests can yield results in several hours, Abbott’s is capable of doing so in five minutes or less. The assessment received praise from President Donald Trump during a news conference in early April and is currently used test White House staff members, according to a recent report from The New York Times.
Since receiving Emergency Use Authorization from the FDA at the end of March, more than 1.7 million Abbott ID NOW tests have been distributed to clinics, hospitals and physicians’ offices across all 50 U.S. states, according to a statement from the company. The statement said Abbott currently manufactures 50,000 diagnostic tests per day and intends to expand manufacturing capacity to reach 2 million per month by June. The FDA has authorized more than 80 diagnostic tests for emergency use over the course of the new coronavirus pandemic.
Abbott Laboratories has also produced an antibody test, which analyzes blood samples to determine whether an individual has ever been infected with the virus, regardless of symptoms. On Monday, the antibody test became one of about a dozen to receive emergency use authorization from the FDA.
The U.S. has reported more diagnoses and deaths due to the new coronavirus than any country impacted by the disease. As of Wednesday afternoon, more than 1.3 million cases had been confirmed throughout the pandemic, with at least 82,806 resulting deaths, according to Johns Hopkins University’s tracker. Additional data from the educational institution indicated 9.6 million test results had been collected nationwide.
