Why Monkeypox Testing Is Still So Difficult and Slow

ItThe federal government responded to the U.S. monkeypox crisis with confidence in June after it was clear that the monkeypox virus outbreak which had started a month earlier would not die down. The pool of at-risk people seemed to be relatively shallow—mostly limited to men who had sex with other men, anyone who had other close contact with a confirmed or suspected case, and anyone who had recently traveled to a country where monkeypox was known to be circulating. U.S. Centers for Disease Control and Prevention already has a monkeypox testing infrastructure. The LRN, a network of 67 federal laboratory in 48 states capable of performing more than 8,000 monkeypox lab tests each week, is also in place.

At the time, that might not have seemed like much. Now, just a month later, the outlook looks a lot less optimistic—and that’s largely because too many obstacles still stand in the way of getting people tested and therefore treated. Experts agree that monkeypox testing fails are very similar to the ones that prevented an early and robust response to COVID-19. According to the CDC, there were 2,593 monkeypox cases in 44 U.S. states and Puerto Rico as of July 21. These numbers could be much higher.

“Most likely, we are just seeing the tip of the [monkeypox] iceberg,” says Michael Mina, chief science officer at eMed, a home testing and treatment company. Mina is a former assistant professor of epidemiology from Harvard T. H. Chan School of Public Health. “We know that this is a very widespread virus in our population at the moment, at least among certain groups.”

Boghuma Titanji (assistant professor of infectious disease at Emory University) agrees. “We are not capturing the extent to which community spread is happening in the United States. We’re not fully detecting the spread, and this is very much reminiscent of the early days of COVID.”

There aren’t enough tests

The LRN labs weren’t nearly enough to meet the crushing demand for monkeypox testing in some parts of the country. On June 22, the U.S. Department of Health and Human Services (HHS) authorized five private laboratories—Aegis Science, Labcorp, the Mayo Clinic Laboratories, Quest Diagnostic, and Sonic Healthcare—to perform testing as well. With the help of the private labs, the nationwide weekly testing capacity has increased nearly 10-fold, federal health officials said at a July 15 press conference held by the CDC, HSS and the Food and Drug Administration (FDA)—from 8,000 to 70,000.

Even that’s not adequate—and hotspots are struggling to get a share of tests proportionate to the outbreak there, which was also true early on in the pandemic. “The New York City [lab] does under 20 tests a day, and they are at or near that capacity,” says Joseph Osmundson, a molecular biologist at New York University. “Whereas in Oklahoma City, are you going to have the same need for monkeypox testing right now? No.” According to the CDC, New York state currently has 581 confirmed cases of monkeypox compared to just five in Oklahoma. Some labs are stretched beyond capacity while others remain idle.

Testing for Monkeypox takes too much time

The current tests are able to detect orthopoxvirus only, which is the bigger family of viruses that monkeypox comes from. To confirm whether monkeypox is the virus being carried, any positive orthopoxvirus test results must be submitted to the CDC.

This bottleneck can increase the chance that the virus will spread. “What’s important to understand in any infectious-disease outbreak is that time is spread,” says James Krellenstein, an AIDS activist and co-founder of the group PrEP4ALL, an LGBTQ advocacy group that is now working to help the community deal with monkeypox. “When we allow ourselves to be blinded to the extent of the outbreak, we allow this virus to spread, and we allow our communities to get harmed.”

On July 15, CDC director Dr. Rochelle Walensky said that while positive results will still be sent to the CDC for confirmation, the initial result—the positive orthopoxvirus test—will be counted as a presumptive case of monkeypox, since it is the only orthopoxvirus in wide circulation at present. A positive diagnosis means that an infected individual should be isolated at home until the lesions heal, all scabs are gone and new skin is formed.

The early responses were too restrictive in terms of eligibility

Men who have had sex with others are more likely to contract monkeypox so testing in May or early June was restricted for those in this category. COVID-19 was also restricted to a limited population when they became scarce. Monkeypox can be transmitted by intimate contact, like touching someone with a lesion, rash, or scab from monkeypox; contact with someone with a respiratory condition during extended face-to-face contact, such as kissing, cuddling, or by touching clothes or linens that may have come in direct contact with monkeypox secretions or rash. You can pass it from a pregnant woman to her child by the placenta. Up to now, monkeypox has been confirmed in eight Americans. “We have seen reports in Europe of cases in women, too,” says Titanji. Children from other countries have reported at least two cases.

The walls that used to prevent testing for these groups are now down. “We’re now testing outside of that population [of men who have sex with men,]” said Jennifer McQuiston, a doctor of veterinary medicine and the incident manager of the CDC’s monkeypox response team, at the July 15 press conference. “We’re not really seeing many positives in those people, so it continues to suggest that the outbreak is happening in the focus population.”

Only people with lesions can get tested—even though other symptoms often develop first

“Moving tests into clinics was a great step forward,” says Krellenstein. “But we wasted weeks and weeks when we had very little testing capacity.” That, Krellenstein worries, suggests a large population of infected people who don’t yet know they’re carrying the virus, since monkeypox has an incubation period of up to two weeks.

The virus slowly builds up within the body. While it may be present in bodily fluids like saliva and urine, it is in such low concentrations that current tests can’t detect it reliably. That means that monkeypox tests don’t work at the first sign of symptoms, which may include fever, headache, chills, swollen lymph nodes, and a rash nearly anywhere on the body. The only way to confirm the diagnosis is by examining the affected area with a swab.

“By definition, if you don’t have a lesion, it’s hard to do the test,” said McQuiston. “There are no approved tests to do [it] other ways.”

It can take up to days for test results to be returned if someone is infected and develops lesions. Urgent care centers take about three days to return a result, says Osmundson—but urgent care centers often also require insurance or payment on the spot, which excludes many lower income people. Osmundson is based in New York City. The Department of Health can conduct free tests, however, it takes up to 10 days for results.

“There are significant backlogs in public-health access in cities like New York and San Francisco,” Osmundson says, which are both monkeypox hotspots. “That’s leading to very serious delays in getting results.”

As we saw with COVID-19, waiting days for a positive test result can be dangerous—not only for the infected person, but also for the community at large. Osmundson states that doctors ask patients to keep the infection at bay until they receive their results. However, unlike COVID-19 where a doctor can enforce quarantine, Osmundson points out that there are no restrictions on what a healthcare worker can do.

Treatment delays due to slow testing

Another problem is accessing care during the wait period. Tecovirimat—known as TPOXX—is a drug approved for the treatment of smallpox, and is now the first-line drug for monkeypox as well. The medication is effective, and—much like the COVID-19 antiviral Paxlovid—it works best when symptoms first start; the faster a patient takes it after monkeypox lesions appear, the quicker the infection can be controlled.

However, most doctors won’t prescribe drugs until they have received a positive monkeypox testing. New York City offers an exception to the rule, with the local Department of Health permitting TPOXX use “at the discretion of the treating clinician” even before a positive test is returned. The CDC is not the same, so patients must wait elsewhere until they are confirmed infected.

For people to have their lesions tested, they may need to be located in specific spots.

Monkeypox can appear nearly anywhere on the body, but earlier on in the outbreak, says Osmundson, “the CDC indicated that only external lesions could be swabbed to be tested.” That guidance was out of step with medical reality, since internal lesions—particularly in the anus or rectum—can also occur as a result of sexual transmission.

One monkeypox patient who Osmundson says was a friend of his, and whose case he followed closely, was in excruciating pain from rectal lesions, yet had to wait a week before being approved for a test—a week during which he was initially told his problem might be cancer, not monkeypox. “It took an organized campaign by three people working 12-hour days before he was finally approved for a test,” says Osmundson. “It was unbelievable how difficult it was.” The patient was indeed confirmed to have monkeypox.

Not all healthcare providers will have that experience. However, many still rely upon the old CDC guidance as well as the instructions included in the test kit. The directions include swabbing for external lesions, but also looking at internal blisters to diagnose. “There’s confusion on the user end of the test,” says Osmundson, “with the caregiver asking ‘Am I even allowed to give the patient the result if the test is not approved for internal lesions?’”

These roadblocks to adequate testing create exactly the kind of environment in which viruses thrive and spread, as we’ve seen all too recently with COVID-19. “The vast majority of my epidemiologist friends believe this virus is not going away,” says Osmundson. “We need to [go] pedal to the metal with all possible interventions now.”

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