The CDC sent Ohio a broken COVID-19 test kit in February, letting a virus run wild

By: - September 28, 2020 1:00 am

Lab Technician Carter Tavaglione loads at Janus G3 automated workstation with coronavirus test samples at Advagenix, a molecular diagnostics laboratory, on August 05, 2020 in Rockville, Maryland. Photo by Chip Somodevilla/Getty Images.

On Jan. 2, symptoms kicked in around Ohio for the state’s first residents with COVID-19, a disease caused by the new coronavirus that has infected more than 150,000 residents.

In Ohio, the pandemic had begun — we just didn’t know it yet. 

The early infections, which would only be detected via antibody testing long after the disease ran its course through its hosts, were some of the 537 now-documented instances of the coronavirus leaping around Ohio before officials first detected the disease in Cuyahoga County on March 9.

COVID-19 has the potency to kill and the stealth to spread undetected. As such, testing is critical to find and isolate infected people before they seed trains of transmission.

On Feb. 7, the Centers for Disease Control and Prevention sent the Ohio Department of Health a test kit designed to identify the virus. Almost immediately, lab staff hit a wall. They couldn’t verify the test worked.

Ohio wasn’t alone. The CDC sent kits to 33 states and 70 labs in 66 countries. More than 90% of the labs that first received the test kits found they produced false positives or inconclusive results.

Federal investigators would determine reagents in the kits were likely contaminated in a CDC lab. Had the original kit worked, ODH would have begun independent testing for COVID-19 when there were 88 cases, current state data shows.

Instead, ODH had to send samples to CDC labs in Atlanta. Narrow guidelines at the time said tests were not recommended for non-hospitalized members of the public unless they travelled abroad. These guidelines prevailed while the virus silently spread through Ohio.

ODH did not begin testing for COVID-19 until March 7, when at least 433 Ohioans had already been infected.

The CDC’s failure to provide a working test kit allowed the infected population to grow exponentially and undetected for a full month before Ohio began testing and implementing its response measures like closing schools and ordering residents to stay home.

At least 4,741 Ohioans have died from COVID-19 and a vaccine is still months away, at best. 

This report is based on expert interviews, public records obtained after the Ohio Capital Journal filed a lawsuit against ODH, records obtained through the CDC, a U.S. Department of Health and Human Services audit of the CDC’s handling of the kits, and a report from Senate Democrats on the Health, Education, Labor and Pensions committee.

How it happened

The new coronavirus was first detected in the U.S. via a 35-year-old Washington state man on Jan. 20. Two days later, ODH declared COVID-19 a Class A reportable disease, meaning the department must immediately be notified of all new cases.

ODH began coordinating with local health departments, staffing up a call center, and notifying the public of potential cases. However, it had no ability to test potentially infected residents for the virus. 

The CDC kit arrived Feb. 7. RT-PCR testing, powered by reagents (chemicals) in the kits, works by searching a specimen taken from patients for presence of viral RNA matching the coronavirus, transcribing that RNA into DNA, and amplifying the DNA until it can be detected.

Along with the specimens, any test run includes a positive control reagent, which should show a positive result 100% of the time, and vice versa with a negative control reagent. If they don’t, something likely went wrong with the test. 

ODH sought to validate results on its kit Feb. 7 and again a few days later, without any luck.

By Feb. 15, the Association of Public Health Laboratories, working with the CDC, fielded reports from 47 labs observing “sporadic problems” with the negative controls.

An APHL coronavirus testing task force, composed of lab directors around the country, emailed ODH Lab Director Quanta Brown and other staff about the scope of the problem. 

“Due to the overwhelming number of laboratories that have reported similar issues with the N3 assay, the Task Force does not recommend that any public health laboratory proceed with testing until CDC issues the new primer/probe set for the N3 assay,” an email states. 

In other words, lab staff could not be sure the tests were producing accurate results, given their measurements against the negative control.

At the time, the coronavirus was wreaking havoc in China, and limited to 15 known U.S. cases.  

ODH spokeswoman Melanie Amato said, responding to written inquiries, there was a “heightened sense of urgency” to begin testing in-house at ODH during the month in question.

“We had considered ordering our own primers, probes and master mix, but it would have required a full validation,” she said. “The implication was CDC would have replacement kits distributed within a week or so.”

On March 3, Gov. Mike DeWine took the aggressive step of closing most of the Arnold Classic — a bodybuilding event and large revenue driver in Columbus — to the public and shuttering its trade show as well.

Press Conference
Gov. Mike DeWine convenes a COVID-19 press conference on March 7.

While he acknowledged the fluidity of the situation and the likelihood of Ohioans testing positive in the coming days, DeWine urged caution but said the contagion risk was low.

“Several hours ago, I talked to the Vice President of the United States,” he said to reporters. “He confirmed to me and assured me that based on high level briefings that he participated in today, the risk for the disease remains low. However, we must continue to act with an abundance of caution.”

Following DeWine, then-ODH Director Dr. Amy Acton urged the public to take “normal precautions” like staying home when sick, washing your hands frequently, and coughing into your sleeve. Columbus Public Health Commissioner Dr. Mysheika Roberts made similar comments.

“While cases of community spread have been reported across the United States, it’s important to remember that the CDC says that the risk to the general public is low at this time,” she said.

That same morning, Lance Himes, Acton’s chief of staff, emailed the CDC about the test kits.

“The ability to test specimens in Ohio is critical to our response,” Himes, now interim ODH director, wrote. “The lab is reaching out to its CDC contacts to determine shipping and delivery timing. Can you assist in getting Ohio information on when we might expect the testing kit?”

Ohio received a testing kit March 7. Within two days, ODH confirmed the presence of the virus in three Cuyahoga County residents.

To the public, the pandemic in Ohio had just begun. In truth, it had been raging for months.

Short circuiting an outbreak

Lucas County’s first bout with coronavirus came Jan. 2 when a woman in her 30s caught COVID-19, followed by two more residents in the next two weeks.

Most Americans had not yet heard of any new coronavirus.

Current data, based on post hoc antibody testing, shows at least three Lucas County residents had COVID-19 on Feb. 7. By the time Ohio had a working test kit, there were at least 26, though these figures are likely underestimations. 

At least 364 Lucas County residents have died from COVID-19. 

Testing and isolating an infected person before they spread the disease, said Lucas County Health Commissioner Eric Zgodzinsky in a recent interview, is how you “short circuit” the outbreak.

“Not having every test that we could possibly want is definitely a hindrance,” he said. “I think by not having the ability to test, you definitely affected the course of that response.”

Transmission electron microscopic image of an isolate from the first U.S. case of COVID-19, formerly known as 2019-nCoV. The spherical viral particles, colorized blue, contain cross-sections through the viral genome, seen as black dots. Source: CDC

It’s unclear whether earlier testing would have changed the outcome in Ohio, according to Kelly Wroblewski, director of infectious diseases for American Public Health Laboratories.

On the one hand, testing is the most effective tool to find the sick and isolate them from the healthy before the infection spreads.

“The months of blindness did us no favors,” she said.

But the coronavirus was, after all, a new virus, Wroblewski said. Researchers did not know how it could spread in hosts without symptoms, or through aerosolized droplets. Ohio might not have allocated the limited tests available from one kit effectively.

“I think there’s no way of knowing for sure how much a difference the early testing would have made,” she said. “I mean I wish we had it, but I don’t know that we can look to that as a root cause of why we are where we are.”

The CDC, despite repeated attempts, did not respond to inquiries for this report. An ODH spokeswoman did not respond to interview requests with Himes or Brown, but provided the following statement.

“Since the beginning of the COVID-19 pandemic, the Ohio Department of Health has used every available resource to slow the spread of COVID-19. The time period referenced was when COVID-19 was beginning to spread in the United States. Following the CDC guidelines at the time, tests were only performed on those who had traveled to China and were sent for processing to the CDC lab.”

On Jan. 7, a 75-year-old Miami County woman became, without her knowledge, the 11th Ohioan infected with the new coronavirus.

Vicky Knisley-Henry, a public information officer at Miami County Public Health, said the woman remembered feeling ill in January with a sinus infection and bronchitis. She didn’t live in a congregate living setting and hadn’t traveled.

The World Health Organization had issued its first report on COVID-19 only a week before, so the Miami County woman likely hadn’t heard of the disease and did not seek testing. She found out she had COVID-19 through an antibody test taken in May.

“There were certainly cases early on we missed because we didn’t have testing,” Knisley-Henry said. “Unfortunately, we won’t ever know.”


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Jake Zuckerman
Jake Zuckerman

Jake Zuckerman is a statehouse reporter. He spent three years chronicling the West Virginia Legislature for The Charleston Gazette-Mail after covering cops and courts for The Northern Virginia Daily.