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FDA, Abbott Address Accuracy Concerns About SARS-CoV-2 POC MDx Test

NEW YORK – Both Abbott Laboratories and the US Food and Drug Administration released statements Thursday addressing recent concerns raised about the accuracy of Abbott's ID Now point-of-care test.

A recent study from New York University published Tuesday on the BioRxiv preprint platform compared the results of Abbott and Cepheid's SARS-CoV-2 point-of-care tests and found Abbott's test missed as much as almost half of the cases found positive by Cepheid's Xpert Xpress SARS-CoV-2 test. The study has not been peer-reviewed.

In light of these results, the FDA said it is still evaluating the information and is in communication with Abbott about the potential false negatives. "We will continue to study the data available and are working with the company to create additional mechanisms for studying the test," Tim Stenzel, the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement. 

Stenzel added that the test "can correctly identify many positive cases in minutes," but noted "negative results may need to be confirmed with a high-sensitivity authorized molecular test." Abbott's test received Emergency Use Authorization from the agency in March.

The agency said it has received 15 adverse event reports about the test, suggesting some inaccurate negative results, although the reports can be "incomplete, inaccurate, or unverified."

Abbott, however, has claimed the results from the NYU study "are not consistent with other studies." The firm said it has seen a few studies with sensitivity percentages in the 80s but has "also seen other studies with sensitivity at or above 90 percent, and one as high as 94 percent."

Abbott has agreed to conduct studies for its test using at least 150 positive samples from patients in a variety of clinical settings.

Both Abbott and the FDA noted the potential issues with sample collection that could have impacted the study's results. In its statement, the FDA said it was investigating whether the accuracy issues could "be due to the types of swabs used or the type of viral transport media." Abbott said test outcomes depend on many factors, including "patient selection, specimen type, collection, handling, storage, transport, and conformity to the way the test was designed to be run." 

The firm noted its ID Now test is intended for use near the patient with a direct swab. In reaction to these results, Abbott said it is further clarifying its product information to tell providers "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."