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The Biden administration announced Wednesday that it is authorizing commercial labs to conduct monkeypox testing in an attempt to drastically expand testing as the United States faces a record outbreak that experts fear is far greater than 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 care providers to request testing directly from labs in early July. Companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories and Aegis Sciences.
“By drastically increasing the number of test sites across the country, we make it possible for anyone who has to take the test to do so,” Health and Human Services Secretary Xavier Becerra said in a press release.
Officials say the measure could allow the nation to conduct tens of thousands of tests a week, rather than relying solely on a national network of public labs that can perform more than 8,000 tests a week. But federal officials acknowledge that they may be doing a lot more testing.
The United States has gone from doing about 10 tests a day in early June to 60 tests a day last week, a senior Biden administration official told The Washington Post.
“This is a relative increase, but it is not close to where we want to be,” said a government official, who spoke on condition of anonymity according to the basic rules set by the administration to respond to questions about the monkeypox response.
Some public health experts say that not performing more tests makes it difficult to identify the extent of the outbreak and contain it.
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Under the current system, doctors must report suspected smallpox infections to health department officials who decide whether cases meet the criteria for testing in public labs. Critics say the process, which could involve calling public health hotlines and answering extensive questionnaires, can be slow and cumbersome, deterring doctors from seeking evidence.
Smallpox is caused by injuries and rashes that can be confused with other diseases such as herpes and syphilis. Health officials say patients’ recent symptoms have been different from previous outbreaks, including rashes concentrated around the genitals and no associated fever.
To test for monkeypox, providers should send a swab of a rash to a public laboratory that can identify if the patient is infected with an orthopox virus, referring to the virus family that includes smallpox. of the monkey. A positive result is presumed to be smallpox from the monkey because no other orthopox virus is known to be circulating in the United States and is sent to the CDC for confirmatory testing.
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Activists and public health experts who have pushed for further testing say the Biden administration should have facilitated testing in commercial labs weeks before the outbreak could worsen.
The test being used was developed by the CDC and authorized for use by the Food and Drug Administration.
Prior to making the test available to commercial laboratories, the CDC had to update these authorizations, establish agreements with the five laboratories, and ensure that personnel had personal protective equipment and vaccines to protect themselves from infection. according to a senior public health official who also spoke on condition of anonymity according to the basic rules of the Biden administration.
In recent weeks, FDA officials have begun coordinating with companies that manufacture components for monkeypox test kits to increase production, according to an agency official who spoke on condition of anonymity because they are not authorized to be attributed their comments.
With more than 3,000 cases of monkeypox reported in dozens of countries, the World Health Organization has a meeting on Thursday to consider designating the public health emergency outbreak of international interest.