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Clinical Laboratories and Pathology Groups

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Monkeypox Clinical Laboratory Testing Capacity in US Is Strong according to CDC Director. But Is It really?

Testing capacity has been boosted by inclusion of commercial laboratory companies and the fact that the virus spreads less easily than SARS-CoV-2

At the start of the SARS-CoV-2 pandemic, clinical laboratories were unprepared for unprecedented testing volumes. Fast forward to today, and the monkeypox outbreak has some clinical laboratory managers and pathologists wondering if they might again be faced with a surge in demand for monkeypox testing.

The good news is that so far the supply of tests appears adequate, especially compared to the early days of COVID-19.

Back in spring 2020, many clinical laboratories simply could not keep up with the overwhelming demand for COVID-19 tests. In “In New Hampshire, Cooperation Was Key to Handling Clinical Laboratory Testing Challenges Posed by the COVID-19 Outbreak,” Dark Daily reported how the state’s public health laboratory was not prepared for the surge in test requests.

By comparison, monkeypox testing capacity is currently in a far better position, said Rochelle Walensky, MD, Director of the federal Centers for Disease Control and Prevention (CDC), during a hearing before the US Senate’s Health, Education, Labor, and Pension (HELP) Committee on Sept. 14.

“We’ve always had more capacity than we have had tests coming in,” Walensky noted. “To date, we’ve used about 14% to 20% of our capacity.”

Rochelle Walensky, MD

During a hearing before the Senate Health, Education, Labor, and Pensions Committee on the current state of monkeypox testing capacity in the US, Rochelle Walensky, MD (above), Director at the CDC said, “We worked through commercial labs to expand testing across the country and simultaneously [offered] outreach and education to providers, clinicians, patients, and public health.” At the moment, access to clinical laboratory testing for monkeypox appears stable, but that could change as demand grows. (Photo copyright: CDC.)

Capacity Sits at 80,000 Tests Per Week in the US

When the monkeypox outbreak began, US medical laboratories could run 6,000 tests per week. At the time, this was more than sufficient, according to a White House press briefing.

However, since then, demand for testing has increased across the country to 80,000 tests per week. As part of that effort, the CDC partnered with five commercial laboratories to expand access to testing, according to the federal Department of Health and Human Services (HHS), Dark Daily reported in August.

Those labs included:

Testing capacity also has kept up with demand thanks to biology. Monkeypox, which is in the same orthopoxvirus family of viruses as smallpox, has proven far less virulent than COVID-19, so fewer people are getting infected.

FDA Advises Against Monkeypox Saliva Test

Another boost to capacity in the future may come from new types of monkeypox tests.

Wired reported on Aug. 1 that Flow Health—a California company already distributing COVID-19 tests—has developed a monkeypox test that can detect the virus in saliva. This test would require patients to spit into a tube for a sample, and as such could be distributed for at-home use.

However, in a report released on July 15, the US Food and Drug Administration (FDA) advised providers to only take testing samples from lesions caused by the rash associated with monkeypox infection. The FDA stated that there is currently no clinical data to support the use of other monkeypox tests like Flow Health’s.

Monkeypox Testing Resources Scarce in Some Areas

At the moment, clinical laboratory testing capacity seems stable, however, roadblocks are appearing that may disrupt the availability of monkeypox tests for patients.

Although bringing on five commercial laboratories has increased US testing capacity, MedTech Dive reported on Aug. 10 that for some hospitals and laboratories, resources for monkeypox testing are scarce.

For example, Bellevue Hospital in New York City, which is part of New York University’s Langone Health network, has had trouble dedicating space and staff for monkeypox testing.

“Right now, there’s a lot of confusion in the community about where to get tested, where can people find treatment,” Robert Pitts, MD, an Infectious Diseases Specialist at Bellevue, told MedTech Dive. “There’s just no clear guidance because I think a lot of the different facilities and healthcare systems in New York are still trying to patch together pathways. … We’ve had to borrow space, borrow staff, which has been really, really challenging.”

During August, Bellevue took two primary care providers out of their normal clinical responsibilities to instead focus on monkeypox. And Pitts found himself dedicating four to five hours of his time to monkeypox-related issues, MedTech Dive reported.

“And so, I’m using my own time, because it’s a crisis, to respond to it,” he said.

The US healthcare system has been somewhat more efficient at getting monkeypox tests out to clinical laboratories than was the case with COVID-19. Moreover, new tests may be on the way. However, roadblocks exist that must be overcome to ensure monkeypox testing capability will meet growing demand.

Ashley Croce

Related Information:

Senate HELP Committee Holds Hearing on Monkeypox Federal Response

CDC Tracks Monkeypox Outbreak

White House: Press Briefing by Press Secretary Karine Jean-Pierre and Covid-19 Response Coordinator Dr. Ashish Jha

Senate HELP Committee Holds Hearing on Monkeypox Federal Response

Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test

As Monkeypox Cases Increase, Disease Experts Lament Lack of Testing Access

When It Comes to Monkeypox Testing, Clinical Laboratories Should Be Aware of Five Significant Developments

There are reports of phlebotomists refusing to draw monkeypox blood samples and social stigma surrounding the disease can affect who gets a medical laboratory test

Cases of monkeypox are increasing in the US—14,115 as of Aug. 19, up 1,400 from the prior week—and clinical laboratories around the country are bracing for a potential increase in monkeypox testing orders.

Several factors, however, are affecting the testing. Chief among them:

  • Lab workers refusing to take blood draws from potential monkeypox patients, and
  • Community clinics in some cities having to delay other care to deal with an onslaught of monkeypox test orders.

Here are five trends clinical laboratory leaders should be aware of that are influencing the state of monkeypox testing in the country.

Trend 1: Some Phlebotomists Refuse to Draw Possible Monkeypox Specimens

CNN reported that phlebotomists at two of the largest commercial laboratories—Labcorp and Quest Diagnostics—were either refusing or being told not to draw blood samples from suspected monkeypox patients.

“Labcorp and Quest don’t dispute that, in many cases, their phlebotomists are not taking blood from possible monkeypox patients,” according to CNN. “What remains unclear, after company statements and follow-ups from CNN, is whether the phlebotomists are refusing on their own to take blood or if it is the company policy that prevents them. The two testing giants say they’re reviewing their safety policies and procedures for their employees.”

In “Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test,” Dark Daily noted that skin lesion swabbing, such as that necessary to perform the Orthopoxvirus PCR test, is the preferred method to check for monkeypox because of higher viral counts in the lesions. However, physicians may order follow-up blood tests for confirmed monkeypox patients, and suspected patients may need bloodwork as part of other routine care.

In an update posted on its website, Quest noted it has been testing swab specimens of skin lesions for monkeypox, but those swabs are performed by providers and not Quest. However, the company was also preparing to take blood draws of possible monkeypox patients in its patient service centers.

“Given that monkeypox has been declared a national public health emergency and the most recent CDC guidance, we are now implementing procedures to safely enable patients with suspected or confirmed monkeypox infection into our patient service sites for phlebotomy blood draws and other non-swab specimen collections,” Quest stated. “This approach will enable patients with suspected or confirmed monkeypox infections to receive additional testing they may need.”

Trend 2: Guidance Is Available to Help Lab Workers Avoid Monkeypox Infection

The CDC has posted guidance to maintain infection control around suspected monkeypox specimens. Among the steps noted by the agency:

  • Lesion specimens from patients suspected of having monkeypox will carry the highest quantity of the virus. When possible, lab workers that have a smallpox vaccination from within the last three years should handle these specimens. Smallpox vaccination also protects from monkeypox in many cases. Unvaccinated workers who test suspected monkeypox specimens need to take extra precautions, such as wearing a buttoned lab coat, gloves, and face protection, and avoiding splashes, the CDC stated.
  • Blood specimens draw from suspected monkeypox patients will have a low quantity of the virus. Lab workers testing these specimens do not need to be vaccinated for monkeypox, but standard precautions should be followed.
  • Before using automated testing platforms with suspected monkeypox specimens, labs should conduct a risk assessment to identify potential hazards.

Trend 3: Monkeypox Testing Gains an Early Social Stigma

Some people who need to be tested for monkeypox may be hesitant to seek out a medical laboratory or patient service center because of a stigma being attached to the disease.

Although it does not match the early hysteria associated with HIV infections in the 1980s—in a 1987 poll, 60% of respondents said AIDS patients should carry a card identifying them as such, Gallup noted—there have been clear instances where people and agencies have associated monkeypox infection with men having sex with other men.

“The focus for all countries must be engaging and empowering communities of men who have sex with men to reduce the risk of infection and onward transmission, to provide care for those infected, and to safeguard human rights and dignity,” Tedros Adhanom Ghebreyesus, PhD, the Director-General at the World Health Organization, said in a July 27 media briefing.

Ghebreyesus added that while 98% of monkeypox infections have been among men who have sex with men, anyone can get the disease, including children.

Tedros Adhanom Ghebreyesus, PhD

“Stigma and discrimination can be as dangerous as any virus, and can fuel the outbreak,” said Tedros Adhanom Ghebreyesus, PhD (above), Director-General at the World Health Organization (WHO), in a media briefing. Clinical laboratories would be wise to prepare for a marked increase in demand for monkeypox testing. (Photo Copyright: WHO/Christopher Black.)

“Men who have sex with men have been hit the hardest by monkeypox to date, but LGBTQ+ health advocates say improper messaging risks branding monkeypox as a ‘gay disease,’ eroding effective preventive measures and allowing the virus to spread,” Bloomberg Law reported.

Further, while many Americans are aware of monkeypox, a significant number don’t know enough about the disease, according to survey results from the Annenberg Public Policy Center of the University of Pennsylvania.

For example, 66% of respondents either were not sure or did not believe there is a vaccine for monkeypox.

Trend 4: Workers Who Refuse to Test Patients for Monkeypox Face Possible Backlash

Some medical professionals have raised concerns about healthcare workers being unwilling to test monkeypox patients.

“This is absolutely inexcusable. It’s a grave dereliction of duty,” David Harvey, Executive Director of the National Coalition of STD Directors, told CNN. The group represents sexually transmitted disease (STD) directors at public health departments in the US.

“For every single patient that walks [through] your door, you use universal precautions because every disease doesn’t have a phenotype or outward appearance, so you have to treat everyone exactly the same,” Garfield Clunie, MD, president of the National Medical Association and Assistant Professor of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, told Bloomberg Law. “You can’t treat someone differently because of their sexual orientation, or race, or gender, or for any other reason.”

Trend 5: Public Clinics Show Early Signs of Monkeypox Testing Pressure

A survey of 80 public health departments conducted by the National Coalition of STD Directors indicated that some sites may already be getting overwhelmed by demand for monkeypox testing.

According to the survey results, 79% of public health clinics saw an increased demand for monkeypox testing over the past four weeks. In a troubling aspect, 28% of clinics said they could not meet testing demand if it increases.

Further, 22% of clinics have reduced screenings for other STDs to prioritize monkeypox testing. Such moves likely delay patients from receiving other care they need.

Clinical laboratories may want to take note of the survey findings. The pressure public health clinics currently face could be a precursor to similar problems at labs if demand for monkeypox testing grows.

Scott Wallask

Related Information:

Some Lab Techs Refuse to Take Blood from Possible Monkeypox Patients, Raising Concerns about Stigma and Testing Delays

NCSD Releases Second Survey of Clinic Capacity in Monkeypox Response

AIDS Echoes in Monkeypox Messages Worry LGBTQ Health Advocates

WHO Director-General’s Opening Remarks at the COVID-19 Media Briefing—27 July 2022

CDC: Laboratory Procedures and Biosafety Guidelines

CDC: Monkeypox and Smallpox Vaccine Guidance

Gallup Vault: Fear and Anxiety During the 1980s AIDS Crisis

Quest Diagnostics Media Statement about COVID-19 and Monkeypox Testing

Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test

Labcorp monkeypox testing information

WHO fact sheet on monkeypox