“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We will continue to study the data available and are working with the company to create additional mechanisms for studying the test.”
The study conducted by researchers at New York University found that the Abbott ID NOW test showed negative results for a third of nasopharyngeal swab samples that tested positive with drug company Cepheid’s test, and nearly a half — 48% — gave false negatives using samples collected with dry nasal swabs. Both the nasopharyngeal and dry nasal swabs collect samples from the nostril, but the nasopharyngeal tests is inserted much deeper into the nose.
Abbott’s ID NOW tests can still be used, but those that turn up negative may need to be confirmed with a more sensitive authorized molecular test, Stenzel said. The FDA has also received 15 adverse event reports about the test device that suggest some users are receiving inaccurate negative results. The agency said it is working with Abbott to better understand the source of the false negatives with the ID NOW test.
Abbott issued a statement refuting the NYU study. “While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport, and conformity to the way the test was designed to be run,” the drug company said. “ID NOW is intended to be used near the patient with a direct swab test method.”