In early July, Sebastian Kuhn, a 39-year-old nonprofit specialist in Brooklyn, woke up with a fever, a sore back, and swollen lymph nodes in his throat and groin. He underwent a COVID test, which was negative. But Cohn had some clues as to what could happen. Pride ceremonies were held a week ago, and a recent infamous disease has spread greatly in the United States gay community: monkey pox.
Skeptical that he might have contracted the viral illness, Cohen promptly isolated. Two days later, a painful and itchy rash appeared in an intimate place. He knew then that he was on tour. Cohn found an urgent care center where a doctor was able to scan his skin lesions and send them to a lab, where technicians looked for signs of the virus’ genetic material. Then he waited alone at his house.
more than 15,000 Cases of monkeypox have been confirmed worldwide since the outbreak began in May, but the condition, which spreads through close contact with the rash or body fluids of an infected individual, is difficult to diagnose due to Lack of available tests. New York City was once only able to test 10 patients per day. When Cohn fell ill, the system was still running with significant delays. While a similar COVID test can be done the next day In many cases, Kuhn’s positive result for monkeypox took four days to arrive – all while a rash spread all over his body. (Six days later, Cohn got a phone call from a contact tracer working for the local health department. He may have been exposed to monkeypox, the person warned.)
In terms of sheer numbers, the country’s capacity to test for monkeypox has increased dramatically since Kohn came in with the system. On Monday, the Centers for Disease Control and Prevention announce The US is now able to assess 80,000 cases per week, up from 6,000 initially. But the other, more important bottleneck remains stubbornly in place: the CDC official guidance She recommends lab testing for monkeypox using only samples of the patient’s skin, which are taken at the site of a visible rash. As a result, people like Cohn, who suffers from fever and swollen lymph nodes A few days before their pestsThe disease must be allowed to grow before it can be diagnosed. Others may have hidden sores in their mouth or anus, not realizing that they can be tested. And many asymptomatic people will be left to wait and wonder, after exposure, whether they have contracted the infection.
As the outbreak spreads – with more than 2,000 cases in the US, before last number– Public health authorities have doubled down on this restriction: virus testing must use swabs taken from the lesion, according to “Safety Communicationissued by the Food and Drug Administration last Friday. The letter states that “the FDA is not aware of clinical data that support the use of other types of samples, such as blood or saliva, to test for monkeypox virus,” and that testing of these other types “may lead to to false test results.” This annoying message, delivered in A decisive moment In the spread of the virus, it will have a profound impact on how quickly a new monkeypox infection is identified, isolated and treated.
With this disease, like many others, early detection is invaluable as a way to promote early treatment. Vaccination shortly after exposure In many cases, monkeypox can be prevented, and vaccination during the early stage of the disease may reduce the severity of symptoms or limit the duration of infection. Although no medicines for monkeypox have been approved, many of them are Antivirals It was originally believed that smallpox helps. As we’ve seen with COVID antivirals baxlovid and remdesivirThese types of treatments tend to work best when given as soon as possible.
It may be equally important to identify asymptomatic sufferers. that Interesting study Outside of Belgium, published earlier this month but not yet peer-reviewed, swabs taken from the mouth and anus of 224 men were examined in May. The samples were originally collected to look for gonorrhea and chlamydia, but scientists found monkeypox DNA in three of them. None of these men reported any symptoms of disease before or after testing, and none of their contacts did. However, the study authors believe that these potential asymptomatic carriers could be infectious. (guidance From the CDC, last updated at the end of June, says spread can only happen after symptoms start.) Meanwhile, other studies have been conducted in Europe And the Africathat monkeypox DNA can in many cases be detected in saliva, blood, urine and rectal samples, even before the rash appears.
Matt Ford, a 30-year-old actor and video producer who lives in Los Angeles and New York, told me he suspected he transmitted the virus during the very early stage of his infection. he is Monkeypox has been caught Last month, after which he was isolated by Public Health. But he said that in the week between his exposure and when he first noticed skin patches appearing, he spent an evening with a guy he was seeing. This man will later contract the same disease. Looking back, Ford was a little tired during that time, but he didn’t feel unwell enough to give him any attention. If people are already transmitting the virus with few or no symptoms — and we don’t know for sure — an early detection test collected by oral, intravenous or rectal swab may prevent that spread.
However, last week’s warning from the FDA was very specific: Unless you have an active rash, don’t bother getting tested. When the agency asked what specific data it was relying on in its safety communications, the FDA spokesperson only reiterated that the organization was “not aware of clinical data supporting asymptomatic testing or test samples other than those taken directly from the suspected pest.” CDC Director Rochelle Walinsky also confirmed to reporters last week that a Skin lesion required For testing from her institution’s perspective, although she said the CDC Exploring the possibility Examination of saliva, throat and blood.
The authorities’ “lack of evidence” maneuver should be quite familiar at this point. In December 2019 and January 2020, . was released Chinese government Publicly stated that there is no clear evidence of human-to-human transmission of the new coronavirus, the World Health Organization Repeat the claim. Three months later, in April, officials from the World Health Organization stated “no evidence” of this Wearing masks prevents transmission of COVID in a wider societal environment. In the case of monkeypox testing, such conservatism is particularly self-defeating. When public health authorities warn about the lack of clinical data for the effectiveness of blood and saliva tests, they not only ignore a small but growing list of published studies; They also make it more difficult for researchers to collect more clinical data. It should be the Food and Drug Administration and the CDC to encourage Labs to run and evaluate the new tests, said Lee Jay Pharma, a public health physician and professor at Cornell University. Instead, agencies are telling labs to stay away from them.
The Food and Drug Administration (FDA) is right that any new monkeypox test will almost certainly produce some false results. (Even gold-standard skin tests for monkeypox can misclassify cases.) But the advantages of early diagnosis of monkeypox are indisputable: Most people will take precautions to reduce their chances of exposing others if they know they are infected, and contact tracers can track additional cases more quickly.
Ideally, one could imagine incorporating monkeypox testing into the existing sexual health infrastructure. Many members of the gay community used to receive regular screening for HIV and other sexually transmitted diseases, according to Joseph Osmondson, MD, assistant clinical professor of biology at New York University. “There is a real desire in the community to test the range” for monkeypox, he told me. Throat and rectal swabs collected for gonorrhea and chlamydia, for example, can also be tested for the virus. Pharma suggests screening participants for any event where casual sex is expected.
In the current situation, doctors, patients and laboratories will have to defy the explicit advice of US public health authorities in order to make this happen. Labs be It is legal to create their own diagnoses for monkeypox, even in the face of official warnings from the Food and Drug Administration. In fact, some organizations have already started to do so. (If the US government were to officially declare monkeypox a public health emergency – like some politicians It calls for – ironically, this organizational flexibility can be canceled.) Benjamin Pinsky, medical director of the Clinical Virology Laboratory at Stanford, oversaw testing more than 70 patients for monkeypox, using samples from the nose, mouth, rectum, and bladder, in addition to conventional skin scraping. Newer methods, he told me, have already picked up quite a few cases, but that developing those tests without government cooperation has been difficult. Pinsky said that public health laboratories initially refused to provide him with real samples from patients to confirm the validity of his approach. Many less experienced laboratory managers will be completely dissuaded from developing their own protocols, because designing a diagnosis from the start is much more complex than using a ready-made tool provided by the government. Also, no laboratory manager would be eager to explain to hospital officials why he publicly violated the official safety warning.
One only needs to look back at COVID snafus test for 2020 to learn what can happen when government works against, not with, the medical community. At the start of the pandemic, the U.S. Food and Drug Administration prevented laboratories from developing their own COVID detection methods without first completing the arduous licensing process. Hospitals have been encouraged to rely on the official CDC test, just as they are now for monkeypox. The COVID test conducted by the government turned out to have a serious manufacturing defect, which fortunately was not repeated during the monkeypox outbreak. But excessive caution remains a problem, and has once again left the country with a serious lack of diagnostic capacity. The indecisiveness of the United States also distances the country from the international community. The Who is the, parts of CanadaAnd the and the The United Kingdom, for example, everyone Recommended throat swab analysis in some circumstances.
Not that the FDA’s concerns are unfounded. The monkeypox test boom, where anyone and everyone can start marketing their own services with limited oversight, could have unwanted consequences. Once the rules for COVID tests were relaxed, small and inexperienced lab clothes were introduced Diagnostic errors Sometimes, or participate in it exploitative practices. But most labs follow proper quality control procedures, and the Centers for Medicare and Medicaid Services still provides routine supervision. Any risk of false results in such an environment must be weighed against the more dangerous outcome of completely missed cases. Fewer monkeypox tests this summer will inevitably increase the number of people suffering From blistering rash, profuse night sweats, foul rectal secretions, and wide spread.
Members of the gay community want an easier and faster monkeypox test. Public health experts want the same thing. Aggressive case detection may be the only way to control the current outbreak, and most large labs have the ability to detect the presence of monkeypox DNA in a variety of body fluids. We don’t yet know the real-world performance of a monkeypox screening program based on all of these fluids, but clinicians can and should coordinate with each other and with public health agencies to find out. “We want the best diagnoses, the best vaccines, the best treatment protocols, and the best science in the world,” Osmondson told me. “But we’re also in an emergency situation, and people get sick, and they can’t get the care they need.”