On May 14, 2020, Abbott’s ID NOW announced that was further clarifying product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

We’re seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies. While we’ve seen a few studies with sensitivity performance percentages in the 80s, we’ve also seen other studies with sensitivity at or above 90%, and one as high as 94%. 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. ID NOW is intended to be used near the patient with a direct swab test method.

Abbott has been working in collaboration with FDA throughout the Emergency Use Authorization (EUA) process. The world needs a variety of tests in labs and at the point of care if we are to help reduce the risk people have every day of contracting the virus. ID NOW is an important tool in that equation. Risk reduction is the goal, which is why we’re developing and continually optimizing as many tests as we can across all of our diagnostics platforms.