Monkeypox Testing Expanding to Commercial Labs in US

Lucy Hicks

June 23, 2022

Five commercial lab companies will soon begin conducting monkeypox testing, the US Department of Health and Human Services (HHS) said. The move will not only increase testing capacity nationwide, but it will also make testing for monkeypox more convenient for both patients and providers, according to the June 22 announcement.

"By dramatically expanding the number of testing locations throughout the country, we are making it possible for anyone who needs to be tested to do so," said HHS Secretary Xavier Becerra in a statement. The five lab companies are Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare.

Currently, all testing for monkeypox is performed by a network of 67 specialized public health laboratories across 48 states. While these labs can perform over 8000 tests a week, experts say getting approval for a test has been too complicated and has created a bottleneck. With the current process, if a patient is suspected of having monkeypox, the clinician needs to call the local public health department for approval to send a testing kit to one of these specialized laboratories. If the test is approved, the sample is then transported to the lab and is tested.

"It's a stand-alone process that, unfortunately, has been reported to be too cumbersome and timely to really facilitate rapid diagnosis," Jennifer Nuzzo, DrPH, an epidemiologist and the director of the Brown University School of Public Health's Pandemic Center, told Medscape Medical News.

Since the first monkeypox case in the United States was reported to the Centers for Disease Control and Prevention (CDC) on May 17, 173 cases have been detected across 24 states. But that is likely an undercount, Nuzzo said.

"A number of cases of monkeypox identified so far haven't had any epidemiologic link to other known cases, so that means we're missing links in the transmission chain," she said.

Although the CDC issued a health alert on June 14 in which it expanded case definitions to "encourage testing for monkeypox among persons presenting for care with relevant history, signs, and symptoms," the complicated approval process was still in place. "If we just tell clinicians to test but don't make it easy for them, that's a real disincentive for them to actually test," Nuzzo said. "They might talk themselves out of thinking [a rash] is monkeypox."

The complicated approval process will not be required for monkeypox testing at commercial labs, which removes this testing bottleneck. This expanded testing will begin in "early July," according to the HHS announcement, but that is still weeks away, Nuzzo said, and the virus may continue to spread undetected during that time.

"I'm glad they are now committed to expanding testing," she said. "Why it took a month, I can't really tell you."

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