Accuracy Concerns With COVID-19 Diagnostic Test

The FDA has alerted the public to preliminary data suggesting that a COVID-19 diagnostic test may yield inaccurate results. In particular, Abbott’s ID NOW, a test that is being used to examine White House officials, may have led to missed cases of COVID-19 and infected patients who have been falsely cleared. 

Abbott’s ID NOW is a point-of-care test that can be performed quickly with a healthcare professional present. Unlike other tests—which require samples to be shipped to a lab to be evaluated—Abbott’s ID NOW takes only fifteen minutes to yield results. The ID NOW was granted an emergency use authorization (EUA) by the FDA back in March. 

Rapid test results have been widely regarded as a key player in halting any further spread of COVID-19. The Trump administration has shipped upwards of 235,000 Abbott ID NOW tests to U.S. public health laboratories. At the same time, Abbott itself claims to have distributed 1.8 million tests to healthcare facilities across the country.

While no diagnostic test is 100 percent accurate, studies using the Abbott ID NOW have emerged with startlingly high false negatives rates. One study indicated that the test might miss as many as half of all positive COVID-19 cases, overlooking a third of cases detected with a rival test developed by Cepheid. Abbott has disputed the results, citing improper specimen handling and user error, and claiming a false negative rate of 0.02 percent when testing instructions are followed correctly. 

The FDA and Abbott Laboratories are currently investigating whether test results are misrepresented when different types of nasal swabs are used to collect samples and whether viral transport media—used to transport samples—may play a role. In April, Abbott warned healthcare professionals not to use transport chemicals after research from the Cleveland Clinic revealed a 15 percent false-negative rate when samples were stored with these chemicals. 



It should be noted that research against the ID NOW has not been published or peer-reviewed in a medical journal and included 100 patients. Abbott has called attention to independent study results that have found accuracy rates of 90 percent or higher using the ID NOW. 

False-negative results prevent infected patients from seeking immediate treatment while increasing the risk of patients unknowingly spreading the virus to others. In the long run, a high rate of false negatives obscures the true scope of an outbreak. 



While the Abbott ID NOW can diagnose positive cases in mere minutes, negative results may need to be reinforced by the results of other tests, such as a high-sensitivity authorized molecular test. For now, Abbott and the FDA have issued a notification letter to users recommending symptomatic patients with negative test results to confirm results with another test. Abbott plans on initiating post-market studies to evaluate the accuracy of the ID NOW.