Pharmacists Should Be Aware of Accuracy Issues with COVID-19 Testing

COVID-19 testing in the United States has been fraught with pitfalls from Day One and, so far, that seems to be continuing. The FDA recently issued an alert about false negative results with the Abbott ID NOW point-of-care test, even though early authorization was granted for the product on March 27. Here is more information.

SILVER SPRING, MD – Pharmacists involved in COVID-19 testing should be aware of a new alert from the Food and Drug Administration.

Based on early data, the FDA is cautioning about potentially inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19 because of false negative results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue,” explained 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. “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,”

The agency also says it has been working with Abbott to analyze the information gathered to date and also to help create a customer notification letter to alert users that any negative test results which appear inconsistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test.

The FDA emphasizes, however, that no diagnostic test can be 100% accurate because of performance characteristics, specimen handling, or user error.

With scientific studies identifying accuracy issues with Abbott ID NOW, public health officials are trying to determine if the issues could be related to the types of swabs used or the type of viral transport media. Those efforts are hampered by  small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use, the FDA notes.

The alert was based on 15 adverse event reports about the Abbott ID NOW device, suggesting some users are receiving inaccurate negative results. The manufacturer  has agreed to conduct post-market studies for the ID NOW device, with each involving at least 150 COVID-19 positive patients in a variety of clinical settings.

Because of the novel coronavirus crisis, early use authorization for the product was granted by the FDA in a letter dated March 27.

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