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 allowing commercial laboratories to run monkeypox tests in a bid to significantly expand testing as the United States faces a record outbreak that experts fear is far greater than the official number 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 from labs directly by early July. Companies include Quest Diagnostics, Sonic Healthcare, Labcorp, Mayo Clinic Laboratories, and Aegis Sciences.

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

Officials say the move could allow the nation to run tens of thousands of tests per week, rather than relying solely on a national network of public laboratories that can perform more than 8,000 tests per week. But federal officials acknowledge they can run more tests.

A senior Biden administration official told the Washington Post that the United States went from doing about 10 tests per day in early June to 60 tests per day last week.

“This is a relative increase, but it’s not close to what we want it to be,” said an administration official, who spoke on condition of anonymity under ground rules the administration has set up to answer questions about the monkeypox response.

Some public health experts say the failure to do more tests is hampering the ability to determine 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 the criteria for being tested in public laboratories. Critics say the process, which may 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 patients’ recent symptoms have been different than in previous outbreaks, including rashes centered around the genitals and no accompanying fever.

To test for monkeypox, providers must send a swab of the rash to a general laboratory that can determine if a patient has orthopox, a reference to the family of viruses that includes monkeypox. A positive result is presumed to be monkeypox because there are no other orthopoxviruses known to be circulating in the United States and they are sent to the CDC for confirmatory testing.

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Activists and public health experts who have pushed for expanded testing say the Biden administration should have facilitated testing in commercial laboratories weeks ago, before the outbreak worsened.

The test used was developed by the Center for Disease Control (CDC) and approved for use by the Food and Drug Administration.

Before testing was widely available to commercial labs, the CDC needed to update those permits, make agreements with the five labs and make sure employees have personal protective equipment and vaccinations to protect against infection, according to a senior public health official who also spoke of the non-disclosure requirement. His identity under the basic rules of the Biden administration.

Food and Drug Administration officials in recent weeks began coordinating with companies that make ingredients for monkeypox test kits to ramp up production, according to an agency official who spoke on the condition of anonymity because they were not authorized to base their comments.

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

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