Medical Laboratories Respond to Monkeypox Outbreak Using CDC-Developed Diagnostic Test
The federal agency shipped tests to five commercial clinical laboratory companies, augmenting efforts by public health labs
Medical laboratories in the US are ramping up their efforts to respond to an outbreak of monkeypox that has been spreading around the globe. Microbiologists and clinical laboratory scientists will be interested to learn that this infectious agent—which is new to the US—may be establishing itself in the wild rodent population in this country. If proved to be true, it means Americans would be at risk of infection from contact with rodents as well as other people.
The Centers for Disease Control and Prevention (CDC) announced on May 18 that it had identified the infection in a Massachusetts resident who had recently traveled to Canada. As of August 3, the federal agency was reporting 6,617 confirmed cases in the US.
Soon after the CDC’s initial announcement, public health labs belonging to the CDC’s Laboratory Response Network (LRN) were testing for the infection, according to an Association of Public Health Laboratories (APHL) press release. The LRN uses a CDC-developed test designed to detect Orthopoxviruses, the family that includes the monkeypox virus.
“Because there are no other non-variola orthopoxviruses circulating in the US, a positive test result is presumed to be monkeypox,” states the APHL press release.
Commercial Labs Get Involved
Seeking to bolster testing capacity, the federal Department of Health and Human Services (HHS) announced on June 22 that the CDC had begun shipping Orthopoxvirus PCR tests to five commercial lab companies. They include:
“By dramatically expanding the number of testing locations throughout the country, we are making it possible for anyone who needs to be tested to do so,” said HHS Secretary Xavier Becerra in an HHS press release.
Labcorp was first out of the gate, announcing on July 6 that it was offering the CDC-developed test for its customers, as well as accepting overflow from public labs. “We will initially perform all monkeypox testing in our main North Carolina lab and have the capacity to expand to other locations nationwide should the need arise,” said Labcorp chief medical officer and president Brian Caveney, MD, in a press release.
Mayo Clinic Laboratories followed suit on July 11, announcing that the clinic’s Department of Laboratory Medicine and Pathology would perform the testing at its main facility in Rochester, Minnesota.
“Patients can access testing through Mayo Clinic healthcare professionals and will soon be able to access testing through healthcare professionals who use Mayo Clinic Laboratories as their reference laboratory,” Mayo stated in a press release.
Then, Quest Diagnostics announced on July 13 that it was testing for the virus with an internally developed PCR test, with plans to offer the CDC test in the first half of August.
The lab-developed test “was validated under CLIA federal regulations and is now performed at the company’s advanced laboratory in San Juan Capistrano, Calif.,” Quest stated in a press release.
Public Health Emergency?
Meanwhile, the CDC announced on June 28 that it had established an Emergency Operations Center to respond to the outbreak. A few weeks later, on July 23, World Health Organization (WHO) Secretary-General Tedros Adhanom Ghebreyesus, PhD, declared that the outbreak represented “a public health emergency of international concern.”
He noted that international health regulations required him to consider five elements to make such a declaration.
“WHO’s assessment is that the risk of monkeypox is moderate globally and in all regions, except in the European region where we assess the risk as high,” he said in a WHO news release. “There is also a clear risk of further international spread, although the risk of interference with international traffic remains low for the moment. So, in short, we have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the International Health Regulations.”
Still, public health authorities have made it clear that this is not a repeat of the COVID-19 outbreak.
“Monkeypox virus is a completely different virus than the viruses that cause COVID-19 or measles,” the CDC stated in a June 9 advisory. “It is not known to linger in the air and is not transmitted during short periods of shared airspace. Monkeypox spreads through direct contact with body fluids or sores on the body of someone who has monkeypox, or with direct contact with materials that have touched body fluids or sores, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.”
The New York Times reported that some experts disagreed with the CDC’s assessment that the virus “is not known to linger in the air.” But Professor of Environmental Health Donald Milton, MD, DrPH, of the University of Maryland, told The Times it is still “not nearly as contagious as the coronavirus.”
The Massachusetts resident who tested positive in May was not the first known case of monkeypox in the US, however, previous cases involved travel from countries where the disease is more common. Two cases in 2021—one in Texas and one in Maryland—involved US residents who had recently returned from Nigeria, the CDC reported. And a 2003 outbreak in the Midwest was linked to rodents and other small mammals imported to Texas from Ghana in West Africa.
Testing Procedures
The CDC has issued information for healthcare professionals, including guidelines for specimen collection, along with information for laboratory personnel who may be testing the specimens.
CNN reported on Aug. 4 that phlebotomists who work for Quest and Labcorp have refused to draw blood 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.”
One symptom of monkeypox, the CDC states, is a rash resembling pimples or blisters. Clinicians are advised that two swabs should be collected from each skin lesion, though “procedures and materials used for collecting specimens may vary depending on the phase of the rash.”
“Effective communication and precautionary measures between specimen collection teams and laboratory staff are essential to maximizing safety when manipulating specimens suspected to contain monkeypox virus,” the CDC notes. “This is especially relevant in hospital settings, where laboratories routinely process specimens from patients with a variety of infectious and/or noninfectious conditions.”
Perhaps the negative reaction to the CDC’s initial response to the COVID-19 outbreak in the US is driving the federal agency’s swift response to this new viral threat. Regardless, clinical laboratories and pathology groups will play a key role in the government’s plan to combat monkeypox in America.
—Stephen Beale
Related Information:
CDC and Health Partners Responding to Monkeypox Case in the US
CDC Activates Emergency Operations Center for Monkeypox Response
HHS Expanding Monkeypox Testing Capacity to Five Commercial Laboratory Companies
Labcorp to Begin Monkeypox Testing Today, Doubling Nationwide Testing Capacity
Labcorp First National Laboratory to Offer Monkeypox Test
Monkeypox (Orthopoxvirus), DNA, PCR Test
Mayo Clinic Laboratories to Begin Monkeypox Testing Today, Increasing Nationwide Testing Capacity
Mayo Clinic Laboratories Launches Monkeypox Test to Increase Access, Availability
Quest Diagnostics to Begin Monkeypox Testing Today, Increasing Nationwide Testing Capacity
Quest Diagnostics Launches Monkeypox Virus Testing
APHL Supports Public Health Response to Monkeypox, Phased Expansion of Testing
World Health Organization: Monkeypox
CDC Dismisses Airborne Transmission of Monkeypox. Some Experts Disagree.
We Let Monkeypox Spread for Too Long. If It Infects Our Pets, There’s No Getting Rid of It
