"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.
Abbott, however, in a statement released May 14, said studies are "being conducted to understand the role of ID NOW in ways that it was not designed to be used."
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 percent 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.
Abbott notes that its ID NOW is the fastest molecular point-of-care rapid test available today and has been delivering reliable results when and where they're needed. The availability and ease-of-access of ID NOW, which delivers results in minutes rather than a day or more, is helping to reduce the risk of infection in society by detecting more positive results than would otherwise be found. Its full statement follows:
We're seeing studies being conducted to understand the role of ID NOW in ways that it was not designed to be used. In particular, the NYU study results are not consistent with other studies. While we've seen a few studies with sensitivity performance percentages in the 80s, we've also seen other studies with sensitivity at or above 90 percent, and one as high as 94 percent. In another recent study in Washington state, out of approximately 1,000 subjects there were 23 positive for COVID-19 on a lab test and ID NOW picked up 21, demonstrating 91 percent sensitivity and 100 percent specificity. We have many questions for the study authors.
While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method.
It is our responsibility to provide healthcare professionals and the public with accurate information, and that's why we're doing the following:
- Further clarifying our product information to provide better guidance to healthcare providers that negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results should be presumed negative, but if inconsistent with clinical signs and symptoms or necessary for patient management, should be tested with an alternative molecular assay. We are also reinforcing proper sample collection and handling instructions. We are communicating this to our customers.
- Continuing to optimize this test as the world learns more about this virus. We're working to incorporate those learnings into the test as we do with all of our diagnostics tests.
Abbott has been working in collaboration with FDA throughout the Emergency Use Authorization (EUA) process.
The world needs a variety of tests in labs and at the point of care if we are to help reduce the risk people have every day of contracting the virus. ID NOW is an important tool in that equation. Risk reduction is the goal, which is why we're developing and continually optimizing as many tests as we can across all of our diagnostics platforms.