U.S. testing for monkeypox is insufficient to determine how widespread the virus is and where new cases are cropping up, according to infectious disease experts and advocates concerned about a sluggish response to the outbreak that’s already hit 32 countries.
While government labs have the capacity to test as many as 8,000 samples a week, they’re only using 2% of that capability, suggesting that about 23 monkeypox tests are being performed a day, said James Krellenstein, the cofounder of PrEP4All, an HIV advocacy group that widened its focus during the pandemic. Much more testing is needed to find out where the pathogen is and how fast it’s moving, he said.
Monkeypox can be found in African countries, most of which are affected by the spread of disease from animals infected. However, it has also been reported in close contacts, especially among males who have sex. Although it doesn’t move as quickly as COVID-19, more than 1,600 cases have been reported globally since health officials began tracking it last month, including 72 in the U.S. as of Tuesday. Krellenstein noted that this situation recalls COVID-19’s initial days. In those early days, flawed Centers for Disease Control and Prevention tests allowed for the spread of the pandemic in America.
“It’s concerning that the CDC isn’t pushing for this themselves, especially after COVID,” he said in an interview. “This is a critical period: Outbreaks become harder to control as time goes on.”
How much virus?
Monkeypox is diagnosed at designated public health laboratories with a type of Food and Drug Administration-approved molecular test, called PCR, that recognizes viral genetic material. Currently, all tests run through the government’s lab network, which experts say is cumbersome, leading to potential delays in identifying new cases and a risk of missing wider community spread.
Testing is so limited that it’s impossible to tell how much of the virus circulating in the U.S. is being picked up, said Ranu Dhillon, an infectious disease doctor at Harvard Medical School and Brigham and Women’s Hospital in Boston. According to him, it might be just 10% or 90%.
“This challenge of expanding and decentralizing testing in response to an outbreak with widespread, unknown transmission chains is not new,” Dhillon said. “It’s been a common theme in multiple recent outbreaks,” including Ebola, Zika virus and, of course, COVID.
Learn More: There’s Already a Monkeypox Vaccine. The Vaccine is Not for Everyone
Experts urged the decentralization of testing, and support for an expansion to hospitals and labs capable of conducting PCR tests. This is especially important in areas like sexual health clinics that see many patients with monkeypox.
“We absolutely need to ensure that every hospital with a laboratory—a molecular virology laboratory—should be able to test their patients for monkeypox,” said Michael Mina, a former Harvard epidemiologist who is now chief science officer for eMed, which sells at-home COVID tests.
Raj Panjabi, the White House’s senior director for global health security and biodefense, said Friday that more than 300 PCR tests for monkeypox had been performed and there’s been a 45% week-to-week increase. According to the CDC, 556 samples had been collected as of Monday.
U.S. health officials say they’re working to expand testing to companies and other government laboratories. The CDC has published online instructions for making primers—DNA sequences used in PCR tests—so labs can start creating their own monkeypox assays.
Expandement in phases
“We’ve posted guidance on our website with our assay information that anybody could replicate if they wanted to develop their own test,” said Jennifer McQuiston, deputy director of the CDC’s Division of High Consequence Pathogens and Pathology. “We also know that some people want to just lift the CDC assay and install it in a commercial lab and we’re exploring ways to help them do that.”
On Friday, the Association of Public Health Laboratories said that, should the outbreak continue to grow, it supports a “phased expansion” of monkeypox testing in the US. The FDA says it’s preparing to make a molecular emergency use authorization template available in case the outbreak is declared a public health emergency.
Medical technology company Becton Dickinson and Co. and Zaragosa, Spain-based CerTest Biotec said they’re teaming up to develop a PCR assay for monkeypox. Swiss pharma giant Roche Holding AG said it has already developed three different monkeypox tests, while Abbott Laboratories said in late May that it’s working on a test.
Testing giant Labcorp said it’s “evaluating all available options to support increased monkeypox testing,” including partnerships with the CDC, other governmental entities, and groups such as the American Clinical Laboratory Association. Quest Diagnostics Inc. said it isn’t offering a monkeypox test but is exploring options.
As the epidemic grows, bottlenecks could be a greater problem. Bryon Bryon backenson, director of communicable illnesses at the New York State Department of Health, stated that high demand may cause delays in turnaround times at public labs. Washington-based physician saidOn Twitter, he said that it took six hours for him to call his laboratory to report a suspected case of monkeypox.
“One thing we’ve learned from COVID is that availability of testing is very important,” Backenson said. “Having more labs and more people capable of testing is a good thing.”
After the Sept. 11, 2001 terrorist attacks, the U.S. government began to plan for smallpox. Anthrax spores were sent via the mail raising concerns about bioterrorism. That’s helped buttress the health system against emerging diseases like monkeypox, but there are still important gaps that showed up in the early days of the pandemic.
COVID controls were hampered by faulty tests and the central U.S. approach to controlling them, as well as regulatory hurdles. CDC’s tests may have missed one of the earliest U.S. infections, leading to additional community exposure, experts have said. Even though the virus had already spread across the U.S. by that point, there were not many tests performed on February 2020 or March 2020.
Other practices may limit the recognition of monkeypox’s spread. Most testing is currently reserved for people with a characteristic rash and who either are men who have sex with men or have recently traveled abroad, according to Paul Sax, an infectious diseases doctor at Harvard and Brigham and Women’s Hospital. Most of the people tested by New York’s health department have been men, Backenson said. PrEP4All was told by Krellenstein that some people claimed their doctors turned them down for monkeypox testing.
Health officials stated that monkeypox could also be mistaken for other sexually transmitted diseases like herpes and syphilis. Some patients in New York who might have had monkeypox weren’t tested for it because they were positive for other pathogens, Backenson said. This week, the CDC advised doctors that anyone with rashes that are typical of other infections must be evaluated carefully for monkeypox. It is possible to contract coinfections.
The virus could spread to other people if the testing is too restrictive. The focus on men could lead to missed infections in women or children, Harvard’s Dhillon said. According to Dhillon, the U.S. should test monkeypox more often in an effort to determine the extent of the disease.
—With assistance from Jeannie Baumann
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