CDC says a glitch in its bird flu test hasn't harmed the agency's outbreak response, but it has ignited scrutiny of its go-it-alone approach in testing for emerging pathogens.

The agency has quietly worked since April to resolve a nagging issue with the test it developed, even as the virus swept through dairy farms and chicken houses across the country and infected at least 13 farmworkers this year.

At a congressional hearing on July 23, Rep. Brett Guthrie (R-Ky.) asked about the issue. "Boy, that rings of 2020," he said, referring to when the nation was caught off guard by the COVID-19 pandemic, in part because of dysfunctional tests made by the CDC. Demetre Daskalakis, MD, MPH, director of the CDC's National Center for Immunization and Respiratory Diseases, responded that the agency rapidly developed a workaround that makes its bird flu test reliable.

"The tests are 100% usable," he later told KFF Health News, adding that the FDA studied the tests and came to the same conclusion. The imperfect tests, which have a faulty element that sometimes requires testing a sample again, will be replaced soon. He added, "We have made sure that we're offering a high-quality product."

Still, some researchers were unnerved by the news coming 4 months after the government declared a worrisome bird flu outbreak among cattle. The CDC's test is the only one available for clinical use. Some researchers say its flaws, though manageable, underscore the risk of relying on a single entity for testing.

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