Monkeypox tests show US has learned little from COVID-19

U.S. testing for monkeypox is insufficient to determine the extent of the virus and where new cases are emerging, say infectious disease experts and advocates concerned about a slow response to the outbreak that has already struck 32 countries.

While government labs have the capacity to test up to 8,000 samples a week, they’re only using 2% of that capacity, suggesting around 23 monkeypox tests are being done a day, James said. Krellenstein, the co-founder of PrEP4All, an HIV advocacy group that has expanded its reach during the pandemic. Much more testing is needed to find out where the pathogen is and how fast it is moving, he said.

Normally seen in African countries where most human cases are caused by infected animals, monkeypox has spread through close contact, primarily among men who have sex with men. Although it’s not changing as quickly 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 echoes the early days of COVID-19, when faulty tests from the Centers for Disease Control and Prevention allowed the pandemic to spread undetected in the United States, Krellenstein said.

“It’s concerning that the CDC isn’t pushing for this itself, especially post-COVID,” he said in an interview. “This is a critical period: epidemics become more difficult to control over time.”

How many viruses?

Monkeypox is diagnosed in designated 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 testing goes through the government’s network of labs, 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 United States is being detected, said Ranu Dhillon, an infectious disease physician 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 testing in response to an outbreak with widespread and unknown chains of transmission is not new,” Dhillon said. “This has been a common theme in several recent outbreaks,” including Ebola, Zika virus, and, of course, COVID.

Read more: There is already a vaccine against monkeypox. But not everyone needs it

Experts have urged decentralizing testing and supporting an expansion of laboratories and hospitals capable of performing PCR tests, especially in places like sexual health clinics where many monkeypox patients present.

“We absolutely need to make sure that every hospital that has a lab — a molecular virology lab — can test their patients for monkeypox,” said Michael Mina, a former Harvard epidemiologist who is now chief scientific officer of eMed, who sells at- home COVID tests.

Raj Panjabi, White House senior director for global health security and biodefense, said Friday that more than 300 PCR tests for monkeypox had been performed and there had been a 45% increase from one week to the other. The CDC said as of Monday, 556 specimens had been tested.

US health officials say they are working to expand testing to businesses and other government labs. The CDC has posted instructions online for making primers — DNA sequences used in PCR tests — so labs can start creating their own monkeypox tests.

Gradual expansion

“We posted guidance on our website with our test information that anyone could replicate if they wanted to develop their own test,” said Jennifer McQuiston, deputy director of the Division of High Consequence Pathogens and Pathologies at the CDC. “We also know that some people just want to lift the CDC test and set it up in a commercial lab and we’re exploring ways to help them do that.”

On Friday, the Association of Public Health Laboratories said that if the outbreak continues to grow, it supports a “gradual expansion” of monkeypox testing in the United States. The FDA says it is preparing to make a model molecular emergency use authorization available in case the outbreak is declared a public health emergency.

Medical technology company Becton Dickinson and Co. and CerTest Biotec, based in Zaragoza in Spain, said they were teaming up to develop a PCR test 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 they were working on a test.

Testing giant Labcorp said it was “evaluating all available options to support increased monkeypox testing,” including partnerships with the CDC, other government entities, and groups such as the American Clinical Laboratory Association. Quest Diagnostics Inc. said it does not offer monkeypox testing but is exploring options.

Bottlenecks in the system could become a bigger problem as the outbreak grows. High demand can cause delays in the turnaround time for tests at public health labs, said Bryon Backenson, director of communicable diseases at the New York State Department of Health. A Washington-based physician said on Twitter that it took him six hours to make a call to his public health lab about 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 able to test is a good thing.”

US health agencies began planning for a smallpox outbreak after the September 11, 2001 attacks, and mailed anthrax spores raised concerns about bioterrorism. This has helped strengthen the health system against emerging diseases like monkeypox, but there are still significant gaps that surfaced early in the pandemic.

Early COVID control efforts were undermined by the United States’ flawed test kits and centralized approach, as well as regulatory hurdles. CDC testing may have missed one of the first U.S. infections, leading to additional community exposure, experts said. Few tests were carried out in February or March 2020, although the virus was already spreading in the United States at that time.

Other practices may limit 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 who have recently traveled abroad, according to Paul Sax, a Harvard infectious disease physician and at the Brigham and Women’s Hospital. Most of those tested by the New York Department of Health are men, Backenson said. Some people have told PrEP4All that their own doctors have turned them down for testing for monkeypox, Krellenstein said.

Monkeypox can also be confused with certain sexually transmitted infections, such as herpes or syphilis, health officials said. Some patients in New York who may have had monkeypox were not tested because they tested positive for other pathogens, Backenson said. The CDC warned doctors this week that patients with rashes usually characteristic of other infections should be carefully evaluated for monkeypox and that co-infections are possible.

Restrictive testing could create blind spots when the virus spreads to other populations. The focus on men could lead to missed infections in women or children, Harvard’s Dhillon said. The United States should overtest monkeypox to ensure the full extent of the outbreak is known, he said.

—With help from Jeannie Baumann

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