The Minnesota Department of Health (MDH) said Tuesday that it is tightening its “testing criteria” for the coronavirus because of a “national shortage of COVID-19 laboratory testing materials.”
MDH announced that testing at the state’s public health lab will be restricted to hospitalized patients, health care workers, and residents of long-term care facilities.
In a memo sent Tuesday to health care providers, the state said that “hospitals and health care systems should assess whether they can send specimens to a commercial reference laboratory, and determine their own priorities for testing and asses whether these labs have restrictions.”
“Limit sending specimens to the Minnesota Department of Health to those from hospitalized COVID-19 patients. At this time, MDH can also test ill health care workers and ill persons living in congregate settings,” said the memo.
Roche Diagnostics, the U.S. subsidiary of the Swiss biotech company Roche, announced Monday that it has started shipping its commercial test kits to more than 30 hospitals and labs across the country. The company received an Emergency Use Authorization from the FDA for the test and plans to ship 400,000 test kits per week.
“We began shipping test kits immediately so labs could start to offer high-volume testing as soon as possible and give more patients access to reliable diagnostics. Together, we can help combat this serious disease,” Matt Sause, president and CEO of Roche Diagnostics North America, said in a statement, noting that the first shipment will be completed this week.
According to Wired, Roche and Thermo Fisher were the first companies to receive emergency approval from the FDA and currently have a combined two million test kits available.
The Mayo Clinic announced last week that it has developed a new test for detecting the virus and submitted it to the FDA for emergency approval.
“This test should help ease some of the burden that is currently being felt at the Centers for Disease Control and Prevention and state public health laboratories,” William Morice II, president of Mayo Clinic Laboratories, said in a press release.
Doug Schultz, communications director for MDH, said the MDH Public Health Laboratory does not have the instrumentation that runs the Roche test kits.
“The Roche kits are designed for use with instrumentation known as the COBAS 6800/8800 platforms. MDH does not have instrumentation that runs these kits. They are designed more for commercial labs and diagnostic labs that do high daily volume, not reference or analytical labs such as the MDH Public Health Laboratory. We typically don’t have the volume of testing to justify this type of instrumentation,” he said, but noted that MDH will direct a certain portion of testing to Mayo Clinic once it has the Roche test up and running.
“Mayo Clinic in Rochester will be implementing these tests. Once Mayo has the test up and running, we will certainly direct a certain portion of testing to them, assuming they are in a position to accept specimens. We reached out to them last week and they were not yet ready to accept our specimens. Other commercial labs are also at capacity, but if they have the systems to run using the Roche kits, they may be able to accept specimens from Minnesota health care providers once they are up and running,” he added.
Gov. Tim Walz sent a letter last week to Vice President Mike Pence asking the federal government to increase Minnesota’s access to COVID-19 testing kits to a minimum of 15,000 tests per month.
“We have been forced to ration the number of tests performed at our public health lab,” Walz said. “I call upon you to help ensure we appropriately prevent and mitigate the spread of the COVID-19 pandemic.”
As of Tuesday afternoon, Minnesota had 60 confirmed cases of COVID-19 and had tested 2,336 patients.
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