The U.S. Food and Drug Administration alerted the public on Thursday evening that Abbott's (NYSE:ABT) ID NOW coronavirus test could have some serious issues. After receiving 15 adverse event reports the FDA issued a warning that the test could be delivering negative results to people who actually are COVID-19 positive.
The FDA says Abbott's rapid point-of-care test can still be used to correctly identify many positive cases in minutes. Negative results from patients that display any symptoms, though, need to be confirmed with older molecular diagnostics that slowly amplify genetic material with an old-fashioned incubation process.
The pre-published blues
The FDA's warning was preceded by disturbing results from a study that hasn't been peer-reviewed yet. Researchers from NYU Langone Health ran samples from over 100 patients through Abbott's ID NOW COVID-19 test and then ran the same samples through another rapid point-of-care diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test using a variety of sample collection techniques. Depending on the technique used, Abbott's test missed between one-third and 48% of the samples that tested positive with Cepheid's test.
While the NYU study results are troubling, Abbott contends the NYU study wasn't consistent with other studies that suggest the ID NOW COVID-19 diagnostic catches around 90% of positives when used in close proximity to patients as intended. It's also important to understand the ID NOW COVID-19 test wasn't intended to screen asymptomatic people.
To address these sensitivity concerns, Abbott has agreed to conduct post-market studies with at least 150 COVID-19 positive patients.