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Dozens of public health laboratories across the country now use a more general test for orthopoxvirus, a larger category that includes monkeypox, smallpox, and other viruses. Biotech companies Roche and Abbott have announced plans to roll out PCR tests for monkeypox, though the test kits are for now only for research.
The US Centers for Disease Control and Prevention says it is exploring ways to test for monkeypox in states.
Already 74 labs across 46 states — part of a network known as the Laboratory Response Network — are using an FDA-licensed test for orthopoxviruses, CDC Director Dr. Rochelle Walinsky said Thursday.
The current capacity is around 7,000 of these tests per week, with the possibility of expansion if needed.
Much of this capability “was created in response to the threat of biological weapons, and smallpox is the most worrisome orthopoxvirus,” said Dr. Amish Adalja, a senior researcher at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health.
The testing the CDC does is more specific for monkeypox virus, and the agency can also genetically sequence samples. For example, it was by looking at the viral genetic code of the first American patient – a man in Massachusetts who had recently traveled to Canada – that the researchers were able to see that his case of monkeypox exactly matched a case in Portugal.
However, Dr. Jennifer McQuiston, a veterinarian and deputy director of the CDC’s Division of Pathogenesis and Pathology, emphasized that the tests being performed at the CDC aren’t really necessary for patient care.
“The orthopox test applied is a practical test,” she said.
Experts say the measure could include isolating patients, making treatments and vaccines available, and contact tracing to identify other people who may have been exposed to the virus.
Since other orthopoxviruses do not circulate in non-endemic countries such as the United States, one can assume that a positive orthopox test here is indeed monkeypox, according to Adalja.
“I think more diagnostic tests that are closer to patients are better. Commercial assays are better,” Adalja said. “But the truth is, there are no other orthopoxviruses out there now.”
He doesn’t think the lack of testing for monkeypox hampers the public health response “because the chiropractor is positive [case] It will be monkeypox until proven otherwise in the scenario we are in now.”
He added that this is a very different situation from the Covid-19 testing stumbles of 2020, when the world was dealing with a new coronavirus without a major testing alternative, meaning it was often difficult to distinguish Covid-19 from other respiratory viruses such as influenza. On the other hand, we’ve known monkeypox for decades, and there’s a plan in place.
It’s not like Covid,” Adalja said.
Identifying monkeypox
Symptoms of monkeypox can include fever, headache, muscle aches, and swollen lymph nodes. A feature of the disease is a rash that produces lesions or blisters. This can happen anywhere on the body, often in places such as the face, hands, and feet. In the current outbreak, some cases have caused infections in the genital or groin area, according to health officials.
The process of determining a case of monkeypox in the United States begins with a person noticing possible symptoms and seeking medical attention. Chris Mangal, director of public health preparedness and response for the Association of Public Health Laboratories, said a provider can contact their local or state health department to collect a sample for orthotic testing.
At this time, the CDC recommends collecting two samples — swabs from the lesions.
“When they do this test, and if that test is positive, they will report a presumptive positive for non-variola orthopoxvirus. And that positive assumption is actually good enough — that, combined with what you see in relation to a patient presentation — to give them a sense of the That “we have to take public health action here,” Mangal said.
The second sample and test results are sent to the Centers for Disease Control and Prevention for testing.
“The CDC and public health laboratories are actually working very closely, in tandem, on this testing,” Mangal said.
During the monkeypox outbreak, she said, the confirmatory testing process was “good enough for the stage we’re at right now” because there weren’t many cases.
“If we get into the scenario where we’re seeing a lot more monkeypox cases, I think the CDC will then work with [US Food and Drug Administration] and public health laboratories to make sure they have this confirmatory ability,” she said, adding that there are a few scenarios that could happen if that happens.
“We could have public health labs developing their own lab tests,” Mangal said. “If this rises to an emergency scenario, similar to Covid, laboratories can work through the FDA to obtain an emergency use authorization for confirmatory tests.”
But Mangal said generally she does not see the current outbreak developing into a major emergency. For the general public, she said, “I think they shouldn’t be overly concerned.”
Adalja said the current ability to test for monkeypox “is not a major public health concern” in general, but there is still room for it to move faster or be more widely available.
“It would be great if Quest and LabCorp could do that,” he said. “It would be great if there were kits that people could put into STD clinics for a definitive diagnosis.” “But now I don’t think you’re hampering the public health response, just because there is no other orthopoxvirus circulating.”
Even if the CDC diverts tests for monkeypox to state public health laboratories, Adalja added, it may take some time to get confirmed results.
“Even though we’re talking about that state public health labs and members of the CDC Laboratory Response Network are able to do orthodox PCR, it’s still a step — it still involves paperwork, it still involves making phone calls, Which discourages people from doing, Adalja said.
“If you work in an STD clinic in some town and you have that group there, or you have a lab in your town that does that, that makes it a lot easier,” he said.
Monkeypox PCR test plans
The monkeypox PCR tests planned by Roche and Abbott are separate from those of the Centers for Disease Control and Prevention.
None of them have received the green light from the US Food and Drug Administration, and the two companies said last week that their tests are for “research use” — although they leave the door open to address future testing needs.
Even if it is not necessary to expand testing in countries like the United States, the moves could benefit other countries, including those in West and Central Africa where monkeypox has long been endemic.
“Some resource-poor countries where these diseases are endemic sometimes have a clearer path to getting these tests into people’s hands than the United States, where there is a lot of regulation and point-of-care testing is very difficult to do,” Adalja said.
“I think there is an advantage to having these tests done in endemic countries so that people can be diagnosed quickly,” he added. “You can detect outbreaks faster. You can spread the smallpox vaccine faster against monkeypox.”
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