Cross contamination of coronavirus test kits reportedly happened at the Centers for Disease Control and Prevention (CDC) central laboratory in Atlanta after manufacturing practices were violated.
The inability of the CDC to rapidly produce a test kit for the novel coronavirus was caused by a “glaring scientific breakdown” at the lab in Atlanta, “according to scientists with knowledge of the matter and a determination by federal regulators,” The Washington Post reported.
“The CDC facilities that assembled the kits violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process,” the Post reported. (RELATED: CDC Officials Hustle To Put Virus-Ravaged Smithfield Foods Back Online After Worker Dies Of COVID)
The scientists added that the “proximity deviated from accepted procedures and jeopardized” testing since the cross contamination likely happened because the chemical mixtures that were used in the tests were within a lab space which previously handled synthetic coronavirus material.
FDA officials concluded that the CDC had breached its own standards in handling the kits, the Washington Post independently confirmed, and the inadequate practices are what caused the kits to be contaminated. The kits are subject to investigation by the Department of Health and Human Services, federal officials said.
The CDC dismissed making those involved in the test kit design or manufacturing available for interview but released a statement through spokesman Benjamin N. Haynes on Friday.
“This issue is being investigated by HHS,” the statement said. “The issue with the N3 component of CDC’s diagnostic test for COVID-19 may be the result of a design and/or manufacturing issue or possible contamination,” 11Alive reported.
Experts said the affected “N3” segment of the test kit was not necessary to detecting novel coronavirus, but after the problem developed, CDC officials took over a month to remove of the irrelevant step. The experts examined federal documents and interviews “with more than 30 present and formal federal scientists and others familiar with the events.” The Post reported that many of them were not authorized to comment publicly, so they spoke on the contingency of anonymity.