PROBES SEEK ANSWERS ON PROBLEMS WITH TEST KITS
Contamination during manufacture caused false results
WASHINGTON
For months, public health officials and members of Congress have wanted to know why the federal government fell short in its efforts to rapidly develop a test to help detect and stop the spread of the novel coronavirus.
Two federal probes are under way into actions at the Centers for Disease Control and Prevention that caused problems with test kits and delayed widespread detection efforts in the United States. But exactly when those examinations will yield answers is unclear, according to Trump administration officials.
The reviews are being led by the headquarters of the Department of Health and Human Services and, separately, by the department’s Office of Inspector General.
Katherine Harris, a spokeswoman for the HHS inspector general’s office, said its audit, opened in midapril, is exploring what the office has described as “CDC’S process of producing and distributing” the test kits. The findings, she said, are not expected to be made public until 2021.
“We want to do nothing to interfere with ongoing emergency response operations,” Harris said by email.
Bill Hall, a deputy assistant HHS secretary for public affairs, declined to estimate when the separate investigation led by HHS headquarters would probably conclude.
Hall said that investigation, started in early March, seeks to “better understand the nature and source of the manufacturing defect in the first batch of COVID-19 test kits that were distributed to state health departments and others.” COVID-19 is the disease caused by the novel coronavirus.
The CDC’S rollout of the test kits was delayed for weeks after the first batch generated dozens of falsepositive results when state and local public health laboratories began using the kits in late January. The false positives occurred within a component of the test that the CDC later said was not necessary to detect the virus.
The Washington Post reported on April 18 that the false positives were caused by contamination that occurred while the kits were manufactured at the CDC’S facilities in Atlanta. An examination by the Food and Drug Administration concluded that the tests failed because of substandard manufacturing practices and that the CDC had violated its own protocol in making the kits, The Post also reported.
In late February, the FDA recommended that the CDC stop manufacturing the kits and shift production to an outside contractor.
Senior CDC officials had earlier declined to remove the troubled component from the design of the test kits. On Feb. 28, the director of the CDC’S National Center for Immunization and Respiratory Diseases, Nancy Messonnier, publicly characterized the test difficulties observed at the public health labs as “inconclusive results.”
The CDC ultimately followed the FDA’S recommendations, but the delay hindered efforts to detect the virus and to blunt its spread throughout the United States. The CDC has not explained the rationale for the original design or what factors led to the breakdown in manufacturing practices.
Benjamin Haynes, a CDC spokesman, said last week that the agency “has implemented enhanced quality control to address the issue” that surfaced with the original test kits.