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FDA Issues Warning on Accuracy of Abbott ID NOW Coronavirus Test

COVID-19 diagnostic sample collection at Boston Hope Medical Center, Mass., on May 8, 2020 by DoD servicemembers deployed to support FEMA. Photo credit: Nicholas Dutton / USAF

The U.S. Food and Drug Administration issued an alert today about early data that suggests potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19.

Abbott Labs’ rapid coronavirus diagnostic test for Covid-19 may be delivering false negative results, the FDA said.

The FDA said it 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,” noted the agency.

One of the studies receiving particular attention, which has yet to undergo peer-review, compares nasal secretions collected by dry swabs for the Abbott test to nasopharyngeal specimen collection for the comparison Cepheid tests. Viral load is inherently higher for nasopharyngeal samples, so assessing lesser sensitivity to Abbott based on this study result is flawed. Additionally, viral transport media was used for Abbott test samples, which is contrary to sample prep instructions for the ID NOW instrument.

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.

“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 reviewing 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results. 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 ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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