The United States Centers for Disease Control and Prevention (CDC) is coming under intense criticism after an investigation revealed that the agency was aware that its initial coronavirus testing kit failed around one-third of the time — and decided to send out the unreliable kits anyway.
According to NPR, the reason that the tests were so unreliable was that the developer of the testing kits, Stephen Lindstrom, built the coronavirus test to mirror the one used for diagnosing the flu. However, the two viruses are very different, and experts have claimed that it is strange that the noted scientist did not model the tests on those used for similar diseases such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS).
The misstep was then compounded by the fact that the lab did not follow the FDA’s mandated protocol during development.
“The first round of [quality control] for final kit release used an ‘incorrect’ testing procedure,” the report claimed.
“Later in the timeline, detection of a 33 percent kit failure” using the proper quality control protocols “did not result in a kit recall or a performance alert,” it continued.
When the lab first discovered that the testing kits were faulty, it was early February and they were boxed and ready to be shipped. However, Lindstrom decided to send them out anyway. His colleagues have since expressed their surprise at this decision, noting that he was usually “meticulous” and that the move was out of character. The scientist may have been under pressure to produce results, or he could have believed that at least some testing, despite its faults, was better than none at all.
Whatever the motivation, doctors on the ground quickly realized that there was an issue as they received inconclusive results over and over again.
“Everybody is waiting for us… We think we have more cases than we’ve been able to detect and the test isn’t working,” described Jennifer Rakeman, director of The New York City Public Health Laboratory.
“We waited another month before we had testing available,” Rakeman added, explaining the long-lasting damage of the ineffective COVID-19 testing.
When the CDC received complaints about the unreliable and unusual results, they blamed low-level contamination in the kit boxes. The excuse made sense as low-level contamination had previously damaged a number of MERS tests years ago.
“Contamination is one possible explanation, but there are others, and I can’t really comment on what is an ongoing investigation,” said Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases.
Since the NPR investigation discovered the story behind the faulty testing, the agency has confirmed that Lindstrom no longer works at the lab and that new measures had been put in place to prevent a repeat of the mishap in the future.