(Bloomberg) – US testing for monkeypox is insufficient to determine how widespread the virus is and where new cases are emerging, according to infectious disease experts and advocates concerned about the slow response to the outbreak, which has already affected 32 countries .
While government labs have the capacity to test up to 8,000 samples a week, they use only 2% of that ability, suggesting that about 23 monkeypox tests are performed a day, said James Krelenstein, co-founder of PrEP4All, an HIV advocacy group that expanded your focus during the pandemic. Much more research is needed to determine where the pathogen is and how fast it is moving, he said.
Commonly seen in African countries, where most human cases are caused by transmission from infected animals, smallpox is spread through close contact, mainly among men who have sex with men. Although not moving as fast as Covid-19, more than 1,600 cases have been reported worldwide since health officials began tracking it last month, including 72 in the United States on Tuesday. The situation reflects the early days of Covid-19, when erroneous tests by the Centers for Disease Control and Prevention allowed the pandemic to spread unnoticed in the United States, Krelenstein said.
“It is worrying that the CDC is not pushing for this, especially after Covid,” he said in an interview. “This is a critical period: outbreaks are becoming more difficult to control over time.
How Much Virus?
Monkeypox is diagnosed in certain public health laboratories with a type of molecular test approved by the Food and Drug Administration called PCR, which recognizes viral genetic material. Currently, all tests pass through the government’s laboratory network, which experts say is cumbersome, leading to potential delays in identifying new cases and the risk of missing out on the general community.
Testing is so limited that it is impossible to say how much of the virus is circulating in the United States, said Ranu Dylan, an infectious disease doctor at Harvard Medical School and Brigham and Women’s Hospital in Boston. It could be 90% or just 10%, he said.
“This challenge of expanding and decentralizing outbreak testing with widespread, unknown transmission chains is not new,” Dylan said. “This is a common theme in many recent outbreaks,” including Ebola, the Zika virus, and, of course, Covid.
Experts have called for decentralization of testing and support for expansion to laboratories and hospitals that can perform PCR tests, especially in places such as sexual health clinics, where many monkey patients appear.
“We absolutely need to ensure that every hospital with a laboratory – a molecular virology laboratory – must be able to test its patients for monkeypox,” said Michael Mina, a former Harvard epidemiologist who is now chief research officer at eMed, which sells tests for Covid at home.
Raj Punjabi, senior director of the White House for Global Health Security and Biosecurity, said on Friday that more than 300 PCR tests for monkeypox had been conducted and that there was a 45% increase from week to week. The CDC said 556 specimens had been tested by Monday.
U.S. health officials say they are working to expand the tests in companies and other government labs. The CDC has published online instructions for creating primers – DNA sequences used in PCR tests – so that laboratories can begin creating their own monkeypox assays.
Gradual expansion
“We have published guidelines on our website with information about our analysis that anyone can reproduce if they want to develop their own test,” said Jennifer McQueston, deputy director of the CDC’s Highly Pathogenic and Pathological Division. “We also know that some people just want to pick up the CDC and install it in a commercial lab, and we’re looking at ways to help them do that.”
On Friday, the Association of Public Health Laboratories said that if the epidemic continues to grow, it supports a “gradual expansion” of monkeypox tests in the United States. The FDA says it is preparing to make an template available for a molecular emergency permit if the outbreak is declared a public health emergency.
Medical technology company Becton Dickinson and Co. and Spain-based CerTest Biotec in Zaragoza said they were teaming up to develop PCR analysis for monkeypox. Swiss pharmaceutical giant Roche Holding AG said it had already developed three different tests for monkeypox, while Abbott Laboratories said in late May that it was working on a test.
Test giant Labcorp said it was “evaluating all available options to support increased monkeypox testing,” including partnerships with the CDC, other government organizations and groups such as the American Clinical Laboratory Association. Quest Diagnostics Inc. said he did not offer a test for monkeypox, but was exploring options.
The bottlenecks in the system can become a bigger problem with the expansion of the hearth. High demand could lead to delays in testing public health labs, said Brian Buckenson, director of infectious diseases at the New York State Department of Health. A Washington-based doctor said on Twitter that it took him six hours to get a call to his public health lab about a suspected case of monkeypox.
“One thing we learned from Covid is that having tests is very important,” Beckenson said. “Having more labs and more people capable of testing is a good thing.
US health agencies have begun planning a smallpox epidemic after the September 11, 2001 attacks and the anthrax controversy sent by mail raised concerns about bioterrorism. This has helped support the health system against emerging diseases such as smallpox, but there are still important gaps that emerged in the early days of the pandemic.
Covid’s early control efforts were hampered by flawed test kits and the US centralized approach, along with regulatory hurdles. CDC tests may have missed one of the earliest infections in the United States, leading to additional community exposure, experts said. Several tests were performed in February or March 2020, although the virus was already spreading in the United States at the time.
Other practices may limit the recognition of the spread of monkeypox. Most tests are currently reserved for people with a characteristic rash who are either men who have sex with men or have recently traveled abroad, according to Paul Sachs, an infectious disease doctor at Harvard and Brigham and Women’s Hospital. Most of the people tested by the New York Health Department are men, Beckenson said. Some people told PrEP4All that their own doctors had refused to test them for monkeypox, Krelenstein said.
Smallpox can also be confused with some sexually transmitted infections, such as herpes or syphilis, health officials said. Some patients in New York who may have had monkeypox have not been tested for it because they have tested positive for other pathogens, Buckenson said. The CDC warned doctors this week that patients with rashes typical of other infections should be carefully evaluated for monkeypox and that coinfections are possible.
Restrictive testing can create blind spots as the virus spreads to other populations. Focusing on men can lead to missed infections in women or children, said Harvard’s Dhillon. The United States must go overboard with monkeypox tests to ensure that the full extent of the outbreak is known, he said.
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