According to the Food and Drug Administration, the Abbott ID Now™ point-of-care test to diagnose coronavirus disease 2019 (COVID-19) may return false negative results based on early data.
The Agency has received 15 adverse event reports related to the test suggesting that users have received inaccurate results, specifically false negatives. A study comparing the performance of ID Now to 2 RT-PCR platforms revealed “low sensitivity with high false negative results” with the Abbott test, which the study authors concluded would “severely diminish the value of the rapid results of the assay.” However, the study, which has not been peer reviewed, was limited by small sample size and design bias and was not conducted according to the manufacturer’s instructions.
In response to the FDA’s concerns, Abbott will conduct post-marketing studies involving at least 150 COVID-19 positive patients to confirm the accuracy of the ID NOW device. In a statement, the Company said it will take further action to help clarify product information to provide better guidance to healthcare providers regarding negative test results:
“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.”
Healthcare providers with questions about the ID Now COVID-19 test can reach Abbott at (224) 667-6100 or by email.
“This test can still be used and can correctly identify many positive cases in minutes,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Negative results may need to be confirmed with a high-sensitivity authorized molecular test.”
For more information visit fda.gov.