_______Announcement of any
unfavorable issues.
Answers
Answer:
Today, the U.S. Food and Drug Administration is 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.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The FDA is sharing early information available about potential inaccurate results in the spirit of transparency. The agency has been working with Abbott to analyze the information gathered to date and has worked with the company 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. No diagnostic test will be 100% accurate due to performance characteristics, specimen handling, or user error, which is why it is important to study patterns and identify the cause of suspected false results so any significant issues can be addressed quickly.
The agency 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.
The FDA 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.
Moving forward, Abbott 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 company or the FDA should take.
The FDA will keep working with Abbott to further evaluate these accuracy issues and will publicly communicate any updates.
Consumers or healthcare providers can reach Abbott directly at (224) 667-6100 or by emailExternal Link Disclaimer.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.