New ID NOW Data Released by Abbott Refutes Negative New York Study Results


Abbott released a positive interim analysis of an ongoing clinical study assessing the accuracy of its ID NOW COVID-19 rapid that showed the test that can provide results within 15 minutes has a high degree of specificity and sensitivity.

The company released the data days after a study conducted in New York showed the test, which has become a daily testing tool in the White House, had a high rate of generating false negatives in COVID-19 cases. The New York test said Abbott’s ID NOW diagnostic tool missed 48% of positive cases that were revealed through a separate clinical test. That test prompted the U.S. Food and Drug Administration to launch an investigation into the claims made in that study.

Following the announced results of that study, Illinois-based Abbott, which received Emergency Use Authorization for the ID NOW test in March, defended its product and speculated that user error is to blame for the plethora of false negatives in the NYU study. The interim data from its ongoing study released Thursday lends weight to some of Abbott’s claims. The company said the interim results demonstrate the ID NOW test shows a greater than 94.7% sensitivity and a 98.6% specificity when compared to two different lab-based molecular polymerase chain reaction (PCR) reference methods. Data from this, as well as two other Abbott-sponsored studies, suggest ID NOW performs best in patients tested earlier post symptom onset, when they are most likely to go for care, the company said. In these studies, ID NOW was used as intended with variations in patient populations based on the number of days a patient was tested after first experiencing symptoms, Abbott added.

In an analysis of the ongoing Urgent Care Clinic Study, ID NOW is showing slightly superior results against Roche’s Roche cobas SARS-CoV-2 assay, which earned EUA in March, and is also demonstrating a higher agreement rate compared to the Centers for Disease Control 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel. The ongoing study is examining ID NOW COVID-19 test performance at five urgent care clinics in New Jersey, Tennessee, Louisiana, Texas and South Carolina. This is one of the first studies conducted on the ID NOW COVID-19 test in a real-world setting as it is intended to be used, compared with other studies that have used banked or retained samples. The second study, The Everett Clinic Study in Washington, is yielding similar results.

Philip Ginsburg, Abbot’s senior medical director of Rapid Diagnostics for infectious disease, said the company is pleased the ID NOW system is delivering on its promise of quick virus detection.

“This is great news for people who are experiencing symptoms and want to take action before they infect others, reducing the spread of infection in society,” Ginsburg said in a statement. “These new interim results reflect what we're hearing from hundreds of our customers, which is that they're seeing results with positive rates from ID NOW that are at, or above, their local COVID-19 infection rates. This tells us that ID NOW is performing comparable to molecular laboratory tests in detecting the virus.”

Data from these studies suggest ID NOW performs best in people tested earlier after they first begin experiencing symptoms, Abbott said. The company will report full results from these studies when the studies and analyses are completed.

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