Monkeypox cannot use the same home test manual as COVID-19

After two years of COVID-19, the conversation around monkeypox testing exudes an unsettling sense of deja vu. The similarities are there: painful swabs, the struggle to even find a test, the bottlenecks and a long wait for results. But the diseases are different enough that the experience with COVID-19 hasn’t given researchers a head start in their efforts to improve the monkeypox testing process.

At the start of the COVID-19 pandemic, experts lamented the lack of investment in rapid home tests for various illnesses in the United States. The idea was that if the infrastructure had been in place before the coronavirus emerged, it would have been easier to scale up testing – and perhaps help control the pandemic. Eventually, this scaling happened anyway. Money and resources poured into testing projects, and soon, at-home COVID-19 testing became ubiquitous. This experience was meant to set the stage for a future with easy access to home testing for a number of diseases once they hit the scene.

In this context, it would seem that monkeypox might offer a perfect test case. It is an unknown disease that is spreading rapidly and there is a high demand for testing. But monkeypox isn’t the best benchmark for whether that future will materialize, says Ben Pinsky, co-medical director of point-of-care testing at Stanford Health Care. “It’s quite a different infection,” he says.

Monkeypox is not a respiratory disease like COVID-19, where the nose and mouth are the clear targets – both for the virus and for testing. The telltale signs of monkeypox are painful blister-like sores, and it can be accompanied by other symptoms like fever and muscle aches. Currently, monkeypox testing involves swabbing wounds that appear during an infection. There are no home tests for other lesions — like herpes, for example, Pinsky says. There’s still a lot of work to be done to determine if people are able to successfully clean their own lesions, which could be painful or difficult, he says.

The reliance on lesions means that patients can only be tested once the telltale signs of the disease appear – which is a sign they should probably be isolated from others anyway. Someone who has been exposed to monkeypox and has a fever but no lesions would not be able to take a test. People can test for COVID-19, on the other hand, without waiting for specific symptoms to appear. “I’m a big proponent of home testing for disease, but you need to have the right sample at the right time, and we’re not there yet,” says Paul Yager, a professor in the University’s bioengineering department. of Washington, in an email to The edge.

It may be possible to test for monkeypox through saliva or semen, according to a small study of 12 patients carried out in June. And some companies are working on tests that don’t involve any lesions at all. A California-based company, Flow Health, has developed a saliva-based molecular test for monkeypox, which asks people to spit into a tube and then send the sample for a PCR test.

The test is not cleared or approved by the Food and Drug Administration. It is offered as part of a program that allows certified laboratories to develop and run their own in-house tests without going through the normal regulatory process. Right now, the FDA still says monkeypox testing should be done on the lesions. The company is sharing its saliva test data with the FDA as the agency checks whether it needs to update its guidelines, Flow Health CEO Alex Meshkin said. The edge.

Much work remains to be done to determine how and when monkeypox virus appears in different parts of the body during illness, which will influence the efficiency and accuracy of tests that do not use lesions. . . If the monkeypox virus appears in saliva before lesions develop, for example, a saliva-based test could help flag the disease at an early stage. But if not, this type of test might not be as useful. Meshkin says Flow Health tested someone who had interacted closely with monkeypox patients but did not yet have lesions and that person tested positive. However, more patients will need to be tested to know for sure when and how the virus manifests.

In addition to the different science, the regulatory and policy landscape around monkeypox also breaks with COVID-19. At this time, monkeypox has not been declared a federal public health emergency in the United States. This changes how various groups might develop tests. At present, home COVID-19 tests are mostly available under emergency use authorizations – an expedited process that allows tests to get to market more quickly in an emergency. Meshkin says Flow Health is prepared to seek emergency use authorization if a public health emergency is declared, which reports say could occur this week.

Without the emergency authorization, companies doing home testing are unable to take some of the same steps they took at the start of the COVID-19 pandemic. They also can’t take the approach of Flow Health, which doesn’t need FDA approval to perform saliva testing in its lab. A home test, by definition, does not use a lab to begin diagnosing patients. These factors may explain why many rapid test platforms that have sprung up in response to COVID-19 have not pivoted directly to monkeypox. Cue Health, which has a rapid molecular COVID-19 test, is working on a “variety of diagnostic tests” but did not specify which ones, spokeswoman Shannon Olivas said in an email to The edge. Detect, which also has a rapid molecular COVID-19 test, said it was in the “concept stage” for a monkeypox test, chief technology officer Eric Kauderer-Abrams said in an email to The edge.

These are all the reasons why testing for monkeypox is more work than relying directly on the COVID-19 experience. But these are not excuses. The healthcare system could have been much better prepared for this particular outbreak. The disease has been common in Africa for years, but global public health has largely failed to devote resources to understanding and preventing it. A Nigerian doctor who tried to raise the alarm over the disease in 2017 was not taken seriously by authorities and the international medical community. Had there been more attention to the disease in recent years, infectious disease experts might have a better understanding of how the virus affects the body – giving them the kind of information they would need to develop easier home tests faster.

Even if we put aside home testing and the logistical differences between the two diseases, you would think that after two years of a brutal pandemic, the United States would have learned how urgent testing can be to bring a disease under control. infectious disease outbreak. There is still more demand for tests than there are tests available, and some people who suspect they have the disease are being turned away by doctors as they struggle to manage the painful symptoms. Unlike the start of the COVID-19 pandemic, monkeypox is a known disease with existing tests, treatments, and vaccines, but the slow response to U.S. outbreaks shows how little the public health system has learned from lessons, even after a two-year crash. course on how illness can disrupt the world.

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