CDC's early coronavirus test kits were faulty because of 'likely' contamination, confirms federal review
The early version of the coronavirus test kits that were produced by the Centers for Disease Control and Prevention (CDC) failed because of "likely" contamination, according to a review by the US Department of Health and Human Services (HHS). Some of the kits, which were shipped across the US and other countries, turned out to be defective.
A three-page summary of the findings said that one of the three reagents used in the initial batch of test kits manufactured by the CDC was likely contaminated. "These tests are so sensitive that this contamination could have been caused by a single person walking through an area with positive control material and then later entering an area where test reagents were being manipulated," said US Health and Human Services assistant secretary for public affairs, Michael Caputo, according to Sinclair Broadcasting Group.
The review was conducted by two HHS lawyers who interviewed close to a dozen scientists, officials and consultants at the CDC and the Food and Drug Administration (FDA) who were involved in the early development of coronavirus test kits. They found that there was "time pressure" at the CDC to launch testing and "lab practices that may have been insufficient to prevent the risk of contamination", reports The Washington Post. It says that the CDC did not check the kits despite "anomalies" during manufacturing. "It appears that time pressure to ship test kits out quickly, and before quality control (QC) had been conducted on them, might have compromised sufficient QC/QA (quality assurance) to identify certain anomalies in data and realize the possibility of contamination before shipment," said the report.
The investigation did not find evidence of the contamination issue leading to any false positive or false negative test results. "We state our conclusions in likelihoods, rather than with absolute certainty due to the inherent complexities of this presumptive contamination and of the underlying science," said the review. In a statement to Sinclair, Caputo defended the CDC. "The CDC and our public health labs were not intended to bear the weight or capacity of nationwide testing on this scale." Caputo also tweeted, "It’s possible this lab contamination may have caused a short delay, but we never had a backlog of tests in this country."
On February 3, 2020, CDC submitted an emergency use authorization (EUA) package to the FDA to expedite the use of the CDC-developed laboratory test kit for Covid-19. The next day, FDA approved the EUA and the test kit began shipping on February 5, 2020, to select, qualified US and international laboratories. In February itself, CDC Director Robert R Redfield acknowledged that some test kits are defective and that the issue has been addressed. "As states began validating the kit in their laboratories, an issue with one of the testing components was discovered. This issue was immediately reported to CDC and no further domestic or international kits were shipped. In addition, in response to this issue, CDC has significantly increased its test throughput in Atlanta allowing for continued monitoring of the outbreak without disruption. CDC is working on remanufacturing the test kit, which will help improve the global capacity to detect and respond to the 2019 novel coronavirus," said Redfield.