Users of the Abbott (NYSE:ABT) ID Now point-of-care diagnostic test for COVID-19 have reported 106 false-negative or otherwise incorrect or inadequate results to the FDA since April — and none for other companies’ rapid diagnostics for the novel coronavirus, according to a report by Kaiser Health News.
That’s up from the 15 adverse event reports the agency reported it had received by May 14, when it issued a warning about the test’s accuracy. The FDA granted the ID Now test an emergency use authorization (EUA) on March 27, and by mid-May said it was investigating whether the false-negative results could be due to the types of swabs used or the type of viral transport media. A preliminary study released in May by researchers at New York University 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 has said that the NYU study results are not consistent with other studies — some with sensitivity performance in the 80th percentile and other studies with sensitivity at or above 90%. One study listed the test’s sensitivity at 94%, the company noted. In a guidance released May 11, the FDA said it considers a 95% accuracy rate for diagnostic tests acceptable.
Abbott began advising customers in mid-April that ID Now is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples. The 106 reported adverse events took place between April 5 to April 27, 2020.
An FDA spokesperson told Kaiser Health News that the agency had not received adverse event reports for any other COVID-19 rapid diagnostic test. The news agency also reported that an FDA official said in May that tests conducted outside of a laboratory might still be useful even if they miss one in five positive cases.
President Trump has touted the ID Now as the test used every day in the White House. Kaiser Health News cited contract records that showed the Executive Office of the President has spent roughly $140,000 on Abbott test kits.
The Abbott Park, Ill.-based company said that it has delivered 3.7 million tests to all 50 states with a complaint rate of 0.017% for false negative results, which it has shared with the FDA.
“COVID-19 testing should not be politicized or sensationalized, but rather scientifically assessed as a part of a broad set of countermeasures to protect public health,” Abbott spokesperson Darcy Ross said in an email to MassDevice. “We strive to be as close to perfection as is scientifically possible, and we are reassured by what we’ve seen in the field. We’ve seen accuracy rates in the mid-90s in some studies, including our own, which is incredible when you consider how far we’ve come in only a matter of a few months. This point-of-care device is helping save lives as a part of complex testing regimen that includes additional laboratory testing for patients that require it. Its accessibility and reliability are critical, and we agree with the experts who see the tremendous value it is providing.”