US expands monkeypox testing in commercial labs as outbreak grows


US expands monkeypox testing in commercial labs as outbreak grows

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The Biden administration announced Wednesday that it is authorizing commercial labs to conduct monkeypox testing in a bid to dramatically expand testing as the United States faces a record outbreak that experts fear is far larger than the official figure of 156 cases.

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

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

Officials say the move could allow the nation to conduct tens of thousands of tests per week instead of just relying on a national network of public labs that can run more than 8,000 tests per week. But federal officials concede they can do far more testing.

The United States has gone from conducting about 10 tests a day in early June to 60 a day for the past 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 according to ground rules set by the administration to answer questions about the monkeypox response.

Some public health experts say the failure to do more testing is hampering the ability to determine the scale of the outbreak and contain it.

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Under the current system, clinicians must report suspected monkeypox infections to Department of Health officials, who decide whether cases meet criteria to be tested in public laboratories. Critics say the process, which could involve calling public health hotlines and answering lengthy questionnaires, can be slow and cumbersome, discouraging doctors from seeking tests.

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

To test for monkeypox, providers must send a swab from a rash to a public laboratory, which can determine if the patient is infected with an orthopoxvirus, which refers to the family of viruses that monkeypox belongs to. A positive result is assumed to be monkeypox since no other orthopoxviruses are known to circulate in the United States and is sent to the CDC for confirmation.

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Activists and public health experts who have been pushing for expanded testing say the Biden administration should have allowed testing at commercial labs weeks earlier before the outbreak could get worse.

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

Before the test can be made widely available to commercial labs, the CDC needed to update those clearances, make arrangements with the five labs, and ensure staff have personal protective equipment and immunizations to protect against infection, a senior public health official said. who also spoke about the condition of anonymity under the ground rules of the Biden administration.

FDA officials in recent weeks 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 they are not authorized to credit their comments.

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

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