News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

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

UK Researchers Discover Previously Unknown ‘Highly Virulent’ HIV Variant Circulating in Netherlands since 1990s

Though the variant poses low risk thanks to modern HIV treatments, the scientists stress the importance of access to early clinical laboratory testing for at-risk individuals

With the global healthcare industry hyper focused on arrival of the next SARS-CoV-2 variant, pathologists and clinical laboratories may be relieved to learn that—though researchers in the Netherlands discovered a previously unknown “highly virulent” strain of HIV—the lead scientist of the study says there’s “no cause for alarm.”

In a news release, researchers at the University of Oxford Big Data Institute said the HIV variant got started in the Netherlands in the 1990s, spread quickly into the 2000s, and that prior to treatment, people with the new virulent subtype B (VB variant) had exceptionally high viral loads compared to people with other HIV variants.

Fortunately, the scientist also found that around 2010, thanks to antiretroviral drug therapy, the severe variant began to decline.

The scientists published their findings in the peer-reviewed journal Science, titled, “A Highly Virulent Variant of HIV-1 Circulating in the Netherlands.”

‘Nobody Should Be Alarmed’

In an interview with NPR, Chris Wymant, PhD, the study’s lead author, said, “People with this variant have a viral load that is three to four times higher than usual for those with HIV. This characteristic means the virus progresses into serious illness twice as fast, and also makes it more contagious.”

Fortunately, he added, “Existing medications work very well to treat even very virulent variants like this one, cutting down on transmission and reducing the chance of developing severe illness.

“Nobody should be alarmed,” he continued. “It responds exactly as well to treatment as HIV normally does. There’s no need to develop special treatments for this variant.”

Wymant is senior researcher in statistical genetics and pathogen dynamics at the Big Data Institute (BDI).

Chris Wymant, PhD
Epidemiologist Chris Wymant, PhD (above), lead author of the Big Data Institute study at Oxford University, says today’s modern HIV antiretroviral drug therapies effectively treat for the “highly viral” HIV VB variant he and his team discovered. “Nobody should be alarmed,” he told NPR. “It responds exactly as well to treatment as HIV normally does.” Nevertheless, he stressed the importance of access to early clinical laboratory testing for at-risk individuals. (Photo copyright: Oxford Big Data Institute.)

Genetic Sequences of the Virulent Virus

About 680,000 people worldwide died from AIDS in 2020, down from 1.3 million in 2010, according to US Health and Human Services HIV data.

In their published study, the BDI researchers reported that their analysis of genetic sequences of the VB variant suggested it “arose in the 1990s from de novo (of new) mutation, not recombination, with increased transmissibility and an unfamiliar molecular mechanism of virulence.

“By the time, they were diagnosed, these individuals were vulnerable to developing AIDS within two to three years. The virus lineage, which has apparently arisen de novo since around the millennium, shows extensive change across the genome affecting almost 300 amino acids, which makes it hard to discern the mechanism for elevated virulence,” the researchers noted.

The researchers analyzed a data set from the project BEEHIVE (Bridging the Epidemiology and Evolution of HIV in Europe and Uganda). They found 15 of 17 people positive for the VB variant residing in the Netherlands. That prompted them to focus on a cohort of more than 6,700 Dutch HIV positive people in the ATHENA (AIDS Therapy Evaluation in the Netherlands) cohort database, where they found 92 more individuals with the VB variant, bringing the total to 109.

According to a Medscape report on the study’s findings, people with the VB variant showed the following characteristics:

  • Double the rate of CD4-positive T-cell declines (indicator of immune system damage by HIV), compared to others with subtype-B strains.
  • Increased risk of infecting others with the virus based on transmissibility associated with variant branching.

Wymant says access to clinical laboratory testing is key to curtailing the number of people who contract the VB variant. “Getting people tested as soon as possible, getting them onto treatment as soon as possible, has helped reduce the numbers of this variant even though we didn’t know that it existed,” he told NPR.

The University of Oxford Big Data Institute study is another example of how constantly improving genome sequencing technology allows scientists to dig deeper into genetic material for insights that can advance the understanding of many diseases and health conditions.

Donna Marie Pocius

Related Information:

New Highly Virulent and Damaging HIV Variant Discovered in the Netherlands

Highly Virulent Variant of HIV-1 Circulating in the Netherlands

Discovery of HIV Variant Shows Virus Can Evolve to Be More Severe and Contagious

Highly Virulent Form of the HIV-1 Virus Has Been Discovered in the Netherlands by an International Collaboration Led by Researchers of Oxford Big Data Institute

Australian Teens Working in Their High School Laboratory Successfully Replicate the Primary Chemical Components of the Costly Drug Daraprim

Improvements in technology are enabling individuals with basic clinical laboratory knowledge to reproduce expensive medical products using low-cost, less complicated methods

Advances in technology made it possible for a group of high school students in Australia to successfully replicate the primary ingredients of a pharmaceutical drug called Pyrimethamine, which is sold under the name Daraprim. It is another demonstration of how today’s sophisticated technologies can be harnessed by individuals with minimal scientific training to produce complex products.

In recent years, Dark Daily has chronicled the successes of high school students in the United States who did the following: (more…)

Mobile Medical Laboratory Brings High-Complexity Infectious Disease Testing to South Africa’s Remote Regions

Immediate access to TB and HIV testing means faster diagnosis and treatment for patients in remote areas

Use of a new mobile medical laboratory is boosting access to quality diagnostic testing for patients in remote areas of South Africa, while slashing turnaround times and courier costs. This German-built mobile clinical laboratory performs high complexity testing and may provide a new model for diagnostic testing for other developing countries.

Fraunhofer Institute for Biomedical Engineering (IBMT) in Saarland, Germany, built the $2 million mobile medical laboratory in collaboration with the government of the Western Cape, a province in southwest South Africa.

The clinical lab-on-wheels operates as an extension of the Caledon Hospital. This is a 75-bed community hospital located in the Overberg district, about 62 miles east of Cape Town. Specimens are sent to the mobile laboratory from health facilities in the surrounding area.

(more…)

;