Monkeypox cannot use the same home testing guide as COVID-19

Monkeypox cannot use the same home testing guide as COVID-19

Two years into COVID-19, the conversation about testing for monkeypox gives an unsettling deja-vu feel. The similarities are there: painful smears, struggle even to find a test, bottlenecks, long wait for results. But the diseases are different enough that the COVID-19 experience hasn’t given researchers much support in their efforts to improve the monkeypox testing process.

In the early days of the COVID-19 pandemic, experts lamented the underinvestment in rapid at-home testing for various diseases in the United States. The belief was that if the infrastructure was in place before the emergence of the coronavirus, it would be easier to scale up testing — and possibly help control the epidemic. In the end, this expansion happened anyway. Money and resources poured into testing projects, and soon home COVID-19 tests were ubiquitous. This trial was supposed to pave the way for the future with easy access to home tests for any number of diseases as soon as they hit the scene.

Against this background, it appears that monkeypox may present an ideal test case. It is an uncommon disease that spreads rapidly, and tests are in great demand. Monkeypox is not the best criterion for determining whether this future will materialize, says Ben Pinsky, MD, co-medical director of point-of-care testing at Stanford University Healthcare. “It’s a different enough infection,” he says.

Monkeypox is not a respiratory disease like COVID-19, in which the nose and mouth are the obvious targets of the virus and testing. The warning signs of monkeypox are painful blisters-like sores, and they can come with other symptoms like fever and muscle aches. Currently, monkeypox tests include scanning for sores that appear during the course of the infection. There are no home tests for other pests — herpes, for example, says Pinsky. There is still a lot of work to do to see if people are able to successfully clear their lesions, which can be painful or difficult, he says.

Dependence on pests means patients can only be tested once they show clear signs of disease – a sign that they may be isolated from others anyway. A person who has been exposed to monkeypox and has a fever but no lesions will not be able to get the test. On the other hand, people can get tested for COVID-19 without waiting for any specific symptoms to appear. Paul Yager, a professor in the University of Washington’s Department of Bioengineering, says in an email to the edge.

It may be possible to test monkeypox through saliva or semen, according to a small study of 12 patients in June. Some companies are working on tests that do not include pests at all. California-based 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 PCR testing.

The test is not authorized or approved by the Food and Drug Administration. It is delivered through a program that allows accredited laboratories to develop and run their own in-house tests without going through the normal regulatory process. For now, the FDA still says that monkeypox tests should be done on the pests. Alex Mishkin, CEO of Flow Health, said the company is sharing its saliva test data with the Food and Drug Administration as the agency is checking to see if it should update its guidance. the edge.

There is still much work to be done on how and when monkeypox virus appears in different parts of the body during the course of the disease, which will affect the effectiveness and accuracy of tests that do not use pests. . If monkeypox virus appears in saliva before the lesions appear, for example, a saliva-based test can help identify the disease early. But if it doesn’t, this type of test may not be helpful. Myshkin says Flow Health tested a person who had closely interacted with monkeypox patients but had no lesions yet, and that that person’s tests came back positive. However, it will take more patients to be tested to know for sure when and how the virus manifests.

Besides the difference in science, the regulatory and political landscape around monkeypox is also deviating from COVID-19. Currently, monkeypox has not been declared a federal public health emergency in the United States. This changes the way different groups may develop tests. Currently, at-home COVID-19 tests are primarily available under emergency use permits — an accelerated process that allows tests to reach the market more quickly during an emergency. Myshkin says Flow Health is ready to apply for an emergency use authorization if a public health emergency is declared, which reports say could come this week.

Without emergency permission, companies running home tests won’t be able to take some of the same steps they took during the early stages of the COVID-19 pandemic. Nor can they take the approach of Flow Health, which does not need FDA approval to run saliva tests in its lab. At-home testing, by definition, does not use a lab to begin diagnosing patients. These factors may contribute to why many of the rapid testing platforms that have emerged in response to COVID-19 have not turned into monkeypox. Health spokeswoman Shannon Olivas said in an email to the edge. Detect, which also has a rapid COVID-19 molecular test, said it is in the “concept stage” of testing monkeypox, chief technology officer. Eric Coudreer Abrams said in an email to the edge.

These are all Reasons Why is monkeypox testing taking more work than relying directly on the COVID-19 experience. But they are not excuses. The health 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. The Nigerian doctor who tried to sound the alarm about the disease in 2017 was not taken seriously by officials and the international medical community. If there has been more interest in the disease over the past few years, infectious disease experts may have a better understanding of how the virus affects the body — giving them the kind of information they need to develop easier home tests more quickly.

Even setting aside home testing and the logistical differences between the two diseases, you’d think that two years into a brutal pandemic, the United States had learned how urgent testing can be to deal with an outbreak of an infectious disease. There is still more demand for the test than there are available tests, and some people who suspect they have the disease are being dismissed by doctors while they struggle to deal with painful symptoms. Unlike the onset of the COVID-19 epidemic, monkeypox is a disease known with existing tests, treatments, and vaccines, but the slow response to the outbreak in the United States shows how few lessons the public health system has learned — even after a two-year crash of course in how the disease can disrupt the world.

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