A total of 1,003 people were evaluated in urgent care clinics, hospitals and nursing homes, where Abbott said ID NOW delivered the following results compared with those of lab-based molecular PCR tests:
- Overall performance of 93.3% positive agreement (sensitivity) and 98.4% negative agreement (specificity). In the 161 patients with high viral titers (Ct <33), and therefore most likely to transmit virus, ID NOW showed performance of 97.0% positive agreement (sensitivity).
- Performance of 95% positive agreement (sensitivity) and 97.9% negative agreement (specificity) in subjects within seven days post symptom onset. In the 129 patients with high viral titers (Ct <33), ID NOW showed performance of 98.4% positive agreement (sensitivity).
- Performance of 94.6% positive agreement (sensitivity) and 97.6% negative agreement (specificity) in symptomatic subjects. In the 136 patients with high viral titers (Ct <33), ID NOW showed performance of 97.8% positive agreement (sensitivity).
Abbott released the interim trial results on the same day that the New York Times published an article claiming the the White House’s reliance on the molecular ID NOW test and an Abbott rapid antigen test, BinaxNOW, have backfired as President Trump and several staffers have fallen ill with COVID-19. The White House switched to BinaxNOW in late August or early September, the Times report said.
Trump was an early supporter of ID NOW, which the White House used regularly on staffers and visitors to the president beginning shortly after the FDA granted the test an emergency use authorization (EUA) in late March.
ID NOW was designed only for the detection of nucleic acid — genetic material — from SARS-CoV-2. It has come under fire since the spring, when researchers at New York University in May released preliminary results of a study that found that the test missed up to 48% of positive results. 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 countered that the test was being used inappropriately in the NYU study. Just days later, the FDA issued a warning that the ID NOW test may return false-negative results. On May 21, one week after the FDA warning, Abbott announced that ID NOW works better on specimens collected soon after patients begin showing symptoms.
“We recognize there is a lot of discussion about testing and ID NOW, and we want to make sure the public has the facts and real-world data,” said Abbott president & CEO Robert B. Ford in a news release. “The facts we’re seeing from one of the largest clinical studies of any COVID-19 test, conducted at some of the nation’s leading academic centers, show that ID NOW delivers effective, consistent and reliable performance.”
“In the beginning of the pandemic, the scientific community had to rely on samples and modeling to predict test performance,” added John Hackett, divisional VP of applied research and technology for Abbott’s diagnostics business. “But now we have a significant body of real-world, clinical data that support the critical role ID NOW is playing in identifying infection rapidly in places where people show up for care.”
Abbott also updated the results of three studies covered in its May 21 interim study press release. That information may be found here.
“Tests are taken at a moment in time and they detect the virus once there’s enough viral material in a person to be able to detect it,” Hackett said in today’s announcement. “While there’s no perfect test, to fight a pandemic, we need a combination of gold standard lab-based PCR and accurate, reliable rapid tests like ID NOW to help reduce risk in society and slow the spread of the virus.”