June 23, 2020 -- The initial COVID-19 test kits created by the CDC failed because of a contaminated component, according to a review by the Department of Health and Human Services.
A reagent in the first batch of test kits was likely contaminated, according to the report obtained by Sinclair Broadcasting Group. The kits were meant to be used by public health laboratories until commercial labs could develop and mass produce coronavirus tests.
“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,” according to the report.
To conduct the review, HHS attorneys collected documents and interviewed about a dozen officials, scientists and consultants at the CDC and FDA who were part of the early test kit development.
According to the report, the CDC realized within two weeks that the tests may have used a contaminated reagent. New reagents were created by private labs and distributed to public health labs in late February.
The review concluded that the CDC faced “time pressure” to launch the kits and that lab procedures may have allowed contamination, according to The Hill. In addition, the kits weren’t checked despite “anomalies” during the manufacturing process.
The review does not seem to blame the CDC directly, according to The Washington Post. However, the findings likely mean that coronavirus numbers were skewed at the beginning of the pandemic.
News outlets previously reported about the CDC lab contamination, which produced false-positive results. At that time, the FDA examined the tests and concluded that the manufacturing process and lab procedures led to the contamination, according to a Washington Post story published in mid-April.