Substandard practices reportedly exposed the novel COVID-19 coronavirus test kits manufactured by the Centers for Disease Control and Prevention to contamination. That in turn led to a delay in their rollout earlier this year, The Washington Post confirmed after speaking with scientists familiar with the matter on the condition of anonymity. The Food and Drug Administration also concluded the CDC violated its own laboratory standards in making the kits, per the Post.
It appears the contamination occurred, in part, because the CDC chose to add a complex and unnecessary component to the kits for reasons that remain unknown. The kits included two standard components that focused on separate regions of the virus' genome, while the third component sought to identify a wider family of coronaviruses, which the Post notes may have been an attempt to bolster the kits' reliability and distinguish other coronaviruses from COVID-19. Among the known coronaviruses, COVID-19 is most closely related to the SARS virus, but the two are only 85 percent identical, which is a "massive difference" when it comes to testing, Northern Arizona University geneticist Paul Keim said. In other words, that third component, which was later confirmed to have been the cause behind inconclusive results, was not essential.
Still, it took CDC officials more than a month to remove the contaminated step from the kits, which led to major delays in testing across the United States, likely contributing to the virus' spread.
It's not exactly clear how the component was contaminated, but the Post reports it likely occurred when chemical mixtures were assembled into the kits in the same lab space handling synthetic, or man-made, coronavirus material. Read more at The Washington Post.