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The Biden administration said Wednesday it has allowed commercial labs to test for monkeypox in a bid to drastically expand tests as the United States faces a record-breaking outbreak that experts fear is far greater than the official number of 156 cases.
The Centers for Disease Control and Prevention began delivering test kits to five commercial laboratory companies this week, allowing healthcare providers to order tests directly from the laboratories until early July. Companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories and Aegis Sciences.
“By drastically expanding the number of testing sites across the country, we are enabling anyone who needs to be tested to do so,” Health and Human Services Minister Xavier Besera said in a press release.
Officials say the move could allow the nation to conduct tens of thousands of tests a week, instead of relying solely on a national network of public laboratories that can conduct more than 8,000 tests a week. But federal officials acknowledge that they can do many more tests.
The United States has moved from about 10 tests a day in early June to 60 tests a week last week, a senior Biden administration official told The Washington Post.
“It’s a relative increase, but it’s not close to where we want to be,” said an administration official, who spoke on condition of anonymity under basic rules set by the administration to answer questions about the monkey’s reaction.
Some public health experts say failing to conduct more tests hampers the ability to identify the extent of the outbreak and control it.
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Under the current system, clinicians must report suspected monkeypox infections to health officials who decide whether the cases meet the criteria for testing in public laboratories. Critics say the process, which could include calling public health hotlines and answering extensive 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 the patients’ recent symptoms were different from those of past outbreaks, including rashes concentrated around the genitals and no associated fever.
To test for monkeypox, providers must send a rash swab to a public laboratory that can identify if the patient is infected with an orthopox virus, referring to a family of viruses that includes monkeypox. Apes are thought to be positive, as other orthopox viruses are not known to circulate in the United States and are sent to the CDC for confirmatory testing.
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Activists and public health experts, who are pushing for more testing, say the Biden administration should have facilitated testing in commercial labs weeks earlier before the outbreak could worsen.
The test used was developed by the CDC and approved for use by the Food and Drug Administration.
Before making the test widely available to commercial laboratories, the CDC had to update these permits, establish agreements with the five laboratories and ensure that staff have personal protective equipment and vaccines to prevent infection, according to a senior public health official who also speaks of a condition of anonymity according to the basic rules of the Biden administration.
FDA officials in recent weeks have begun coordinating with companies that make components of monkeypox test kits to increase production, according to an agency official who spoke on condition of anonymity because they are not authorized to attribute their comments. .
With more than 3,000 cases of monkeypox reported in dozens of countries, the World Health Organization is meeting Thursday to consider identifying an outbreak of public health emergency of international importance.
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