The United States Food and Drug Administration (FDA) has posted a Press Announcement alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.
The FDA has been working with Abbott (the manufacturer) to analyze the information gathered to date and has worked with the manufacturer on a customer notification letter to alert users that any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test.
The FDA looks at a variety of sources to identify and understand potential patterns or significant issues with the use of the Abbott test. The FDA is aware of some scientific studies that have identified accuracy issues with Abbott ID NOW and is investigating whether it could be due to the types of swabs used or the type of viral transport media (material used to transport the patient's specimen). While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer's instructions for use, an important part of scientific research. This is why external scientific studies are one part of the FDA's overall evaluation of a diagnostic performance.
According to the FDA, it has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. The agency is reviewing these reports. It's important to note that the adverse event reports the FDA receives from manufacturers, health care providers, health care facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.
The manufacturer has agreed to conduct post-market studies for the ID NOW device that each will include at least 150 COVID-19 positive patients in a variety of clinical settings. The FDA will continue to review interim data on an ongoing basis. The information gathered from the post-market studies can further help the agency understand the cause or patterns of any accuracy issues and inform any additional actions the manufacturer or the FDA should take. The FDA will keep working with the manufacturer to further evaluate these accuracy issues and will publicly communicate any updates.
For details, please refer to the following link:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-informs-public-about-possible-accuracy-concerns-abbott-id-now-point
Posted on 18 May 2020