COVID-19: VACCINE WATCH

Early CDC test kits were delayed because of contamination issues, HHS report affirms

Jun 20, 2020, 7:02 PM
CDC Valentine's Day...
(Photo by Kevin C. Cox/Getty Images)
(Photo by Kevin C. Cox/Getty Images)

(CNN) — One of two types of test kits produced by the US Centers for Disease Control and Prevention in January were likely contaminated, its parent agency confirmed.

One of three reagents in the initial batch of test kits was likely contaminated, according to a statement from US Health and Human Services Assistant Secretary for Public Affairs, Michael Caputo, on Saturday.

The contamination was discovered after an investigation was conducted by the HHS Office of the General Counsel at the request of HHS Secretary Alex Azar, the statement said.

“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 tests reagents were being manipulated,” Caputo said.

The investigation did not find evidence of the contamination issue leading to any false positive or false negative test results, Caputo said. However, it may have delayed the CDC’s ability to provide tests to public health labs for a short time, according to Caputo.

The CDC has implemented enhanced quality controls to ensure it does not happen again, according to the statement.

This isn’t the CDC’s first brush with compromised testing. Multiple health officials have previously told CNN that contamination in manufacturing the CDC test for the coronavirus caused weeks of delays that slowed the US response to the pandemic.

The problem stemmed in part from the CDC not adhering to its own protocols, a US Food and Drug Administration spokesperson told CNN in April.

“CDC made its test in one of its laboratories, rather than in its manufacturing facilities,” the FDA spokesperson told CNN at the time. “CDC did not manufacture its test consistent with its own protocol.”

As coronavirus test kits malfunctioned in public health labs across the country for weeks, CDC head Dr. Robert Redfield and Azar — then the lead of the coronavirus task force — provided “assurances it was being dealt with,” a senior administration official told CNN in April.

It took roughly three weeks to sort out the failed test kits, far longer than the CDC had anticipated. Along the way, regulators would discover the lab producing the test kits was contaminated, likely causing the tests to malfunction, according to a senior administration official.

The-CNN-Wire
™ & © 2020 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.

Today’s Top Stories

COVID-19: Vaccine Watch

A sign reading "immunizations" hangs over a desk. COVID-19 vaccines Utah...
Samantha Herrera

Where to find a COVID-19 vaccine provider for children 5 and under in Utah

COVID-19 vaccines are now available for children as young as 6 months old, but where can you find a vaccine provider for your child in Utah?
13 days ago
A child is comforted after getting his COVID-19 vaccine....
Samantha Herrera

More COVID-19 vaccines ordered in Utah for children as young as 6 months

32,000 doses of COVID-19 vaccines for children 6 months and older have been ordered by the Utah Department of Health and Human Services.
14 days ago
This combination of 2022 and 2020 file  photos shows logos for the U.S. Centers for Disease Control...
LAURAN NEERGAARD AP Medical Writer

Marathon US hearings to decide fate of COVID shots for tots

On Wednesday, both Moderna and Pfizer will argue their case. Each company aims to offer a different dose and number of shots.
26 days ago
FILE - A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. ...
LOLITA C. BALDOR Associated Press

New vaccine may be option for troops with religious concerns

At least 175 active duty and reserve service members have received the Novavax vaccine. Some have traveled overseas at their own expense to get it.
27 days ago
utah student achievement COVID-19...
Simone Seikaly

Utah student performance knocked down during COVID-19 restrictions

A review of multiple Utah student performance exams found "significant impacts" in mathematics achievement across grades.
1 month ago
COVID-19 vaccine...
KEVIN McGILL

Opponents of federal vaccine mandate seek rehearing

Mr. Biden issued an order Sept. 9 that more than 3.5 million federal executive branch workers undergo vaccination, with no option to get regularly tested.
1 month ago

Sponsored Articles

Tax Harassment...
Jordan Wilcox

The best strategies for dealing with IRS tax harassment | You have options!

Learn how to deal with IRS tax harassment. This guide will teach you how to stop IRS phone calls and letters, and how to handle an IRS audit.
spend a day at Bear Lake...
Bear Lake Convention and Visitors Bureau

You’ll love spending the day at Bear Lake | How to spend a day at Bear Lake

Bear Lake is a place that needs to be experienced. Spend a day at Bear Lake.
Curb Appeal...
Price's Guaranteed Doors

How to have the best of both worlds for your house | Home security and curb appeal

Protect your home and improve its curb appeal with the latest security solutions like beautiful garage doors and increased security systems.
Prescription opioids can be disposed of during National Prescription Take Back Day...
Know Your Script

Prescription opioid misuse | How to protect your family from the opioid epidemic

Studies have shown that prescription opioid misuse has increased since COVID-19. So what do you need to know about these opioids?
national heart month...
Intermountain Healthcare

National Heart Month: 5 Lifestyle Changes to Make Today to Keep You Heart Healthy

Heart disease is the leading cause of death for both men and women. One person dies every 36 seconds in the United States from cardiovascular disease
Joseph Smith Memorial Building...
Temple Square

The Joseph Smith Memorial Building is an icon of Salt Lake City | Why hosting an event at this beautiful location will make you a hero this year

Here's why hosting an event at the iconic Joseph Smith Memorial Building in downtown Salt Lake City will make you a hero this year.
Early CDC test kits were delayed because of contamination issues, HHS report affirms