Dozens of public health labs across the country are already using a more general orthopoxvirus test, a larger category that includes monkeypox, smallpox and other viruses. Two biotech companies, Roche and Abbott, have announced plans to introduce PCR tests for monkeypox, although their test kits are currently only for testing.
The U.S. Centers for Disease Control and Prevention says they are looking at ways to deliver specific monkeypox tests in the United States.
There are already 74 laboratories in 46 states – part of a network known as the Laboratory Response Network – that “use an FDA-approved orthopoxvirus test,” CDC Director Dr. Rochelle Valensky said Thursday.
The current capacity is about 7,000 of these tests per week, with the potential to expand if necessary.
Dr Amesh Adalya, a senior scientist at the Johns Hopkins Health Security Center at the Bloomberg School of Public Health, said much of this capacity “was created in response to the threat of biological weapons, and smallpox is the most alarming orthopoxvirus. “
The testing that the CDC does is more specific for the monkeypox virus, and the agency can also genetically sequence samples. For example, looking at the viral genetic code of the first patient in the United States – a man from Massachusetts who recently traveled to Canada – researchers were able to see that his case of monkeypox was very similar to that of Portugal.
However, Dr. Jennifer McQueston, a veterinarian and deputy director of the Department of Pathology and Pathology with High Consequences at the CDC, stressed that the tests conducted at the CDC are not actually necessary for patient care.
“The on-site orthopox test is an applicable test,” she said.
Experts say the action could include isolating patients, providing treatment and vaccines, and tracking contacts to determine who else may have been exposed to the virus.
Since other orthopoxviruses do not spread to countries where they are not as endemic as the United States, it can be assumed that a positive orthopox test here is indeed apes, according to Adalia.
Countries such as Spain have shifted to including orthopox-positive cases as confirmed cases of monkeypox in their censuses. The CDC’s U.S. Case Tracking Program lists “generally confirmed cases of monkeypox / orthopoxvirus.”
“I think more diagnostic tests closer to patients are better. “The trade analysis is even better,” Adalia said. “But the fact is, there are no other orthopoxviruses right now.”
He does not believe that the lack of specific tests for monkeypox interferes with the public health response, “because positive orthopox [case] it will be monkeypox until proven otherwise in this current scenario. “
He added that this is a very different situation from the obstacles in testing Covid-19 from 2020, when the world was dealing with a new coronavirus without a major alternative to testing, which means that it was often difficult to distinguish Covid-19 from other respiratory viruses such as Influenza. We have known about monkeypox for decades, and there is a plan.
“It’s not the same as Covid,” Adalya said.
Identification of monkeypox
Monkeypox is rare outside of endemic countries and is not as transmitted as a virus like Covid-19, according to the CDC. Humans can be infected by animals, but humans can also become infected through skin-to-skin contact; large droplets that tend to travel no more than a few feet; or contact with things contaminated with skin lesions, such as bed linen.
Symptoms of monkeypox may include fever, headache, muscle aches, and swollen lymph nodes. The disease is characterized by a rash that leads to lesions or pustules. This can happen anywhere on the body, often in places such as the face, arms and legs. In the current outbreak, some cases have caused lesions in the genital area or groin, according to health officials.
The process of identifying a case of monkeypox in the United States begins with a person noticing possible symptoms and seeking medical attention. Their provider could contact a local or state health department to collect a sample for orthopox testing, said Chris Mangal, director of public health preparedness and response at the Public Health Laboratories Association.
Currently, the CDC recommends the collection of two samples – swabs from lesions.
“When they perform this test and if this test is positive, they will report a suspected positive for non-smallpox orthopoxvirus. And this supposedly positive is actually good enough – that, combined with what you see about the patient presentation – to give them the feeling that “we need to take action on public health here,” Mangal said.
The second sample and the test result are sent to the CDC for own testing.
“The CDC and public health labs are actually working closely together, hand in hand, on this testing,” Mangal said.
During the monkeypox epidemic, the confirmatory testing process was “good enough for the current phase” because there were not many cases, she said.
“If we enter the scenario where we see a significantly higher number of cases of monkeypox, I believe that the CDC will work with [US Food and Drug Administration] and public health labs to ensure they have this confirmatory ability, “she said, adding that there are several scenarios that could develop if that happens.
“We can get public health labs to develop their own lab-designed tests,” Mangal said. “If this rises to an emergency scenario similar to Covid, laboratories can work through the FDA to obtain an emergency authorization for confirmatory tests.
But overall, Mangal said, she does not see the current outbreak becoming a major emergency. For the general public, “my opinion is that they should not be overly concerned,” she said.
The current capacity to test for monkeypox is generally “not a serious public health problem,” Adalia said, but there is still room to move faster or be more widely available.
“It would be great if Quest and LabCorp could do it. “It would be great if there were kits that people could put in sexually transmitted disease clinics to finally diagnose,” he said. “But I don’t think you’re blocking the public health response right now just because there’s no other orthopoxvirus circulating.”
Even if the CDC transfers the smallpox-specific tests to public public health laboratories, it may take time to get confirmatory results, Adalia added.
“Although we are talking about public laboratories for public health and members of the CDC’s laboratory response network that can do orthodox PCR, this is still a step – it still includes documents, it still involves making phone calls, which dissuades people. to do this there is a built-in delay, “Adalya said.
“If you work in a sexually transmitted disease clinic in a city and you have that kit there, or you have a lab that’s right in your city that does it, it makes it a lot easier,” he said.
Plans for PCR tests for monkeypox
The PCR tests for monkeypox planned by Roche and Abbott are separate from the CDC’s plans.
Neither has received the green light from the FDA, and the two companies said last week that their tests were intended for “research use” – although they left the door open to meet future testing needs.
Even if tests do not need to be expanded in countries such as the United States, these moves could be beneficial to other countries, including those in West and Central Africa, where the monkeypox virus has long been endemic.
“Some of the resource-poor countries where these diseases are endemic sometimes have a clearer path to getting these tests in people’s hands than in the United States, where there are so many regulations and it’s so difficult to get tested on the spot. , “Said Adalia.
“I think there is an advantage to doing these tests in endemic countries so that people can get diagnoses quickly,” he added. “You can detect outbreaks much faster. You can get the smallpox vaccine faster than monkeypox.”
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