Skip to main content
The Globe and Mail
Support Quality Journalism
The Globe and Mail
First Access to Latest
Investment News
Collection of curated
e-books and guides
Inform your decisions via
Globe Investor Tools
Just$1.99
per week
for first 24 weeks

Enjoy unlimited digital access
Enjoy Unlimited Digital Access
Get full access to globeandmail.com
Just $1.99 per week for the first 24 weeks
Just $1.99 per week for the first 24 weeks
var select={root:".js-sub-pencil",control:".js-sub-pencil-control",open:"o-sub-pencil--open",closed:"o-sub-pencil--closed"},dom={},allowExpand=!0;function pencilInit(o){var e=arguments.length>1&&void 0!==arguments[1]&&arguments[1];select.root=o,dom.root=document.querySelector(select.root),dom.root&&(dom.control=document.querySelector(select.control),dom.control.addEventListener("click",onToggleClicked),setPanelState(e),window.addEventListener("scroll",onWindowScroll),dom.root.removeAttribute("hidden"))}function isPanelOpen(){return dom.root.classList.contains(select.open)}function setPanelState(o){dom.root.classList[o?"add":"remove"](select.open),dom.root.classList[o?"remove":"add"](select.closed),dom.control.setAttribute("aria-expanded",o)}function onToggleClicked(){var l=!isPanelOpen();setPanelState(l)}function onWindowScroll(){window.requestAnimationFrame(function() {var l=isPanelOpen(),n=0===(document.body.scrollTop||document.documentElement.scrollTop);n||l||!allowExpand?n&&l&&(allowExpand=!0,setPanelState(!1)):(allowExpand=!1,setPanelState(!0))});}pencilInit(".js-sub-pencil",!1); // via darwin-bg var slideIndex = 0; carousel(); function carousel() { var i; var x = document.getElementsByClassName("subs_valueprop"); for (i = 0; i < x.length; i++) { x[i].style.display = "none"; } slideIndex++; if (slideIndex> x.length) { slideIndex = 1; } x[slideIndex - 1].style.display = "block"; setTimeout(carousel, 2500); }
Coronavirus information
Coronavirus information
The Zero Canada Project provides resources to help you make the most of staying home.
Visit the hub

In this Wednesday, March 11, 2020 file photo, a technician prepares COVID-19 coronavirus patient samples for testing at a laboratory in New York's Long Island.

The Associated Press

Shockingly sloppy laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed Saturday.

Two of the three CDC laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs, according to the Food and Drug Administration.

Early on, the FDA, which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the CDC labs to assess the problem, several officials said. He found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process, they said.

Story continues below advertisement

Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.

In a statement Saturday, a spokeswoman for the FDA, Stephanie Caccomo, said, “CDC did not manufacture its test consistent with its own protocol.”

The FDA confirmed its conclusions late this week after several media outlets requested public disclosure of its inquiry, which assuredly is part of a larger federal investigation into the CDC lab irregularities by the Department of Health and Human Services.

Tension mounts in U.S. over plans to reopen the economy as Trump appears to encourage protests

Forced to suspend the launch of a nationwide detection program for the coronavirus for a month, the CDC lost credibility as the nation’s leading public health agency and the country lost ground in ways that continue to haunt grieving families, the sick and the worried well from one state to the next.

To this day, the CDC’s singular failure symbolizes how unprepared the federal government was in the early days to combat a fast-spreading outbreak of a new virus and it also highlights the glaring inability at the onset to establish a systematic testing policy that would have revealed the still unknown rates of infection in many regions of the country. The blunders are posing new problems as some states with few cases agitate to reopen and others remain in virtual lockdown with cases and deaths still climbing.

While President Donald Trump and other members of his administration assert almost daily that the U.S. testing capacity is greater than anywhere else in the world, many public health officials and epidemiologists have lamented the lack of consistent, reliable testing across the country that would reflect the true prevalence of the infection and perhaps enable a return to some semblance of normal life.

President Donald Trump announces that additional coronavirus tests have been deployed, at the Centers for Disease Control and Prevention in Atlanta, March 6, 2020.

T.J. Kirkpatrick/The New York Times News Service

Dr. Robert R. Redfield, the director of the CDC, and other health experts have long suggested that contamination in the labs might have been the culprit. But even as several officials at the FDA late this week cited contamination as the cause, a spokesman for the CDC, Benjamin Haynes, asserted that it was still just a possibility and that the agency was still awaiting the formal findings of HHS.

Story continues below advertisement

In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the coronavirus test development. Since then, he said, “CDC implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”

Initially, the CDC was responsible for creating a coronavirus test that state and local public health agencies could use to diagnose COVID-19 in people, and then isolate them to prevent the spread of the disease.

“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”

Becker said that public health laboratories started receiving the CDC kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the CDC and the FDA, which regulates medical devices, including laboratory tests.

“This is consistent with what we said was plausible when we found the problem at the beginning,” Becker said. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”

This content appears as provided to The Globe by the originating wire service. It has not been edited by Globe staff.

Report an error
Due to technical reasons, we have temporarily removed commenting from our articles. We hope to have this fixed soon. Thank you for your patience. If you are looking to give feedback on our new site, please send it along to feedback@globeandmail.com. If you want to write a letter to the editor, please forward to letters@globeandmail.com.

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff. Non-subscribers can read and sort comments but will not be able to engage with them in any way. Click here to subscribe.

If you would like to write a letter to the editor, please forward it to letters@globeandmail.com. Readers can also interact with The Globe on Facebook and Twitter .

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff. Non-subscribers can read and sort comments but will not be able to engage with them in any way. Click here to subscribe.

If you would like to write a letter to the editor, please forward it to letters@globeandmail.com. Readers can also interact with The Globe on Facebook and Twitter .

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff.

We aim to create a safe and valuable space for discussion and debate. That means:

  • Treat others as you wish to be treated
  • Criticize ideas, not people
  • Stay on topic
  • Avoid the use of toxic and offensive language
  • Flag bad behaviour

Comments that violate our community guidelines will be removed.

Read our community guidelines here

Discussion loading ...

To view this site properly, enable cookies in your browser. Read our privacy policy to learn more.
How to enable cookies