APRIL 20, 2020 Intelligence: Late-Breaking Lab News

Not only did the outbreak of SARS-CoV-2 in the United States show how unprepared the nation was for an event like this, but it exposed numerous problems and weaknesses in the federal agencies tasked with protecting the health and safety of the American public.

One high-profile failure happened when the Centers for Disease Control and Prevention (CDC) shipped defective COVID-19 test kits to public health laboratories in early February. It took almost a month for the federal agency to address the problem and ship accurate test kits. Last week, the Washington Post reported that the problem with the unreliable kits was due to contamination during the manufacturing process.

MORE ON: CDC’s COVID-19 Test Kits

As reported by the Post, the problem was only corrected after the Food and Drug Administration (FDA) worked with the CDC team, and Integrated DNA Technologies, Inc. (IDT), of Coralville, Iowa. They determined that the issue was contamination during the CDC’s manufacturing process. With the problem identified, IDT then manufactured the kits and materials that the CDC distributed to public health labs at the end of February.

IDT is authorized by the CDC to sell COVID-19 primer and probe kits.


One new tool for tracking an infectious disease outbreak is to check sewers and wastewater plants for the infectious agent. Recently, water at a major urban treatment facility serving a large area of Massachusetts was tested for COVID-19. Newsweek reported that researchers on the team came from Biobot Analytics, the Massachusetts Institute of Technology (MIT,) Harvard University, and Brigham and Women’s Hospital. Tests done from March 18-25 found higher quantities of SARS-CoV-2 than what had been originally predicted. Researchers consider this strong evidence that a much greater number of people are infected with the novel coronavirus.


• Pathologist Roger D. Klein, M.D., J.D., FCAP, was appointed Chief Medical Officer at OmniSeq of Buffalo, N.Y. He maintains his consultancy, Roger D. Klein, MD, JD, Consulting. Previously, he served at the Arizona State University College of Law, Cleveland Clinic, BloodCenter of Wisconsin, and Moffitt Cancer Center.



Have you caught the latest e-briefings from DARK Daily? If so, then you’d know …

…early examples of serology test kits for COVID-19 that proved inaccurate or unreliable. For example, Spain purchased 640,000 test kits from a Chinese company, with a claim of 80% sensitivity. But in use, the COVID-19 kits averaged 30%.

You can get the free DARK Daily e-briefings by signing up www.darkdaily.com.

That’s all the insider intelligence for this report. Look for the next briefing on Monday, MAY 11, 2020.



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