U.S. to expand monkeypox testing at commercial labs as outbreak grows

U.S. to expand monkeypox testing at commercial labs as outbreak grows

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The Biden administration announced Wednesday that it is authorizing commercial labs to test for monkeypox in a bid to dramatically expand testing as the United States grapples with a record-setting outbreak that experts fear is far higher than the official count of 156 cases. .

The Centers for Disease Control and Prevention began shipping test kits to five commercial lab companies this week, allowing health providers to order tests directly from labs in early July. Companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories and Aegis Sciences.

“By dramatically expanding the number of testing locations across the country, we are making it possible for anyone who needs to get tested to do so,” Health and Human Services Secretary Xavier Becerra said in a news release.

Officials say the move could allow the nation to run tens of thousands of tests a week, instead of relying solely on a nationwide network of public labs that can run more than 8,000 tests a week. But federal officials acknowledge they may be doing a lot more testing.

The United States went from conducting about 10 tests a day in early June to 60 tests a day last week, a senior Biden administration official told The Washington Post.

“That’s a relative increase, but it’s nowhere near where we want to be,” said an administration official, who spoke on condition of anonymity under ground rules set by the administration for answering questions about the monkeypox response.

Some public health experts say the lack of more testing hampers the ability to identify the extent of the outbreak and contain it.

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Under the current system, doctors must report suspected monkeypox infections to health department officials, who decide whether cases meet criteria for public laboratory testing. Critics say the process, which could involve calling public health hotlines and answering lengthy questionnaires, can be slow and cumbersome, deterring doctors from seeking tests.

Monkeypox causes lesions and rashes that can be confused with other diseases such as herpes and syphilis. Health officials say the patients’ recent symptoms have been different from previous outbreaks, including rashes concentrated around the genitals and no associated fever.

To test for monkeypox, providers must send a swab from a rash to a public laboratory that can identify whether the patient is infected with an orthopox virus, referring to the family of viruses that includes monkeypox. A positive result is presumed to be monkeypox because no other orthopox viruses are known to be circulating in the United States and is sent to the CDC for confirmatory testing.

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Advocates and public health experts who have pushed for expanded testing say the Biden administration should have facilitated commercial lab testing weeks earlier, before the outbreak could worsen.

The test used was developed by the CDC and authorized for use by the Food and Drug Administration.

Before the test was widely available to commercial labs, the CDC needed to update those authorizations, establish agreements with the five labs, and ensure staff had personal protective equipment and vaccinations to protect against infection, according to a senior public health official. who also spoke about the condition of anonymity under the ground rules of the Biden administration.

In recent weeks, FDA officials have begun coordinating with companies that make the components of monkeypox test kits to ramp up production, according to an agency official who spoke on condition of anonymity because he is not authorized. to have your comments attributed.

With more than 3,000 cases of monkeypox reported in dozens of countries, the World Health Organization is meeting Thursday to consider designating the outbreak a public health emergency of international concern.

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