Another COVID-19 is being investigated for faults, resulting in the United States Food and Drug Administration (FDA) to warn people that the Abbott ID NOW point-of-care test may return inaccurate, false negative results.
The warning stems from some scientific studies that have identified accuracy issues in the test. The FDA is examining whether this is due to the types of swabs used or the type of material used to transport patients’ specimens. The FDA acknowledged that no diagnostic test would be 100 percent accurate. However, the studies raising alarms have a variety of limitations themselves, including small sample sizes, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said. “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.”
In its examinations, the FDA is working with Abbott to analyze the information gathered. Abbott is currently working on a customer notification letter to alert users that their negative test results may not be consistent with their symptoms, signs, or actual health — and may need to be confirmed with another test. To ensure the test’s accuracy, the FDA will weigh sources and chart potential patterns or significant issues. Whatever it finds, Abbott has agreed to conduct post-market studies for its ID NOW device with at least 150 COVID-19 positive patients in various clinical settings.
Total, the FDA has so far received 15 adverse reports regarding the Abbott ID NOW device.