Nowadays, the U.S. Food and Drug Administration is alerting the public to further data that recommends possible incorrect effects from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Precisely, the search may return false-negative outcomes.
“We are still assessing the data about incorrect results and are in close relations with Abbott about this critical point. We will proceed to analyze the data available and are going with the business to generate new mechanisms for reading the test.
This test can still be practiced and can accurately classify many real cases in minutes. Adverse effects may require to be established with a high-sensitivity accredited molecular analysis,” said Tim Stenzel, M.D., Ph.D., the manager of the Office of In Vitro Diagnostics in the FDA’s Center for Devices and Radiological Health.
The FDA Data
The FDA is giving new data available about possible wrong issues in the spirit of clarity. The agency has been struggling with Abbott to explain the data gathered to date and has worked with the organization on a customer information letter to alert users that any adverse test results that are not compatible with a patient’s clinical indications and symptoms or necessary for patient control should be verified with another test.
The FDA studies various experts to recognize and understand possible patterns or vital issues with the Abbott test. No diagnostic test will be 100% true due to performance features, specimen handling, or user error, which is why it is necessary to study designs and identify the cause of presumed false results so any vital issues can be written quickly.
The agency is aware of some experimental studies that have known efficiency problems with Abbott ID NOW. It is studying whether it could be due to the kinds of swabs used or the type of viral transportation media (a material used to transport the patient’s specimen).
While there is excellent news to gather from these considerations, it should be regarded that these studies have flaws. These include a small sample size, potential design biases, or questions that may not have been made according to the manufacturer’s regulations for use, an indispensable part of scientific research.
This is why externally controlled studios are one part of the FDA’s overall evaluation of individual performance.
The FDA has taken 15 adverse event articles about the Abbott ID NOW device, which suggests that some users are receiving inaccurate negative results. The agency is investigating these reports.
It’s highly crucial to remark that the adverse event reports the FDA receives from the manufacturers, health care providers, health care facilities, and sufferers can be incomplete, wrong, or unverified, so agency staff must meticulously comb through the records to recognize essential data to help any signals or models about device use.
Abbott ID NOW
Moving ahead, Abbott has agreed to send post-market studies for the ID NOW device that each will hold at least 150 COVID-19 positive sufferers in a variety of clinical settings.
The FDA will proceed to review interim data continuously. The data gathered from the post-market knowledge can further help the agency know the cause or designs of any accuracy issues and notify any further actions the business or the FDA should take.
The FDA will keep working with Abbott to evaluate these accuracy issues further and will publicly communicate any updates.