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Labs push back on WH testing claims citing lack of critical supplies

Labs push back on WH testing claims citing lack of critical supplies
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Academic medical labs pushed back Tuesday on the Trump administration's assertion that they are underutilizing COVID-19 testing equipment that could help increase the country's diagnostic testing capacity.

In a letter to White House coronavirus task force coordinator Deborah BirxDeborah BirxWhite House largely silent on health precautions for Thanksgiving The Hill's Morning Report - Presented by the UAE Embassy in Washington, DC - Pence, Biden wage tug of war over pandemic plans Fauci, Birx urge Americans to take precautions against virus in rare White House appearance MORE, the Association of American Medical Colleges (AAMC) said its member labs are trying to increase capacity but are hamstrung by the lack of critical testing supplies. 

The group urged the White House to take a more active role in managing the supply chain for key testing materials.

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Reagents, swabs, personal protective equipment and specialized testing kits designed by companies to be used with their own machines are all in short supply.

Without those materials, the machines can't run, the group said.

"As we have come to learn over the past several weeks, despite the best efforts of all parties, not one of these components is readily available in sufficient quantities to each and every lab that needs them," the hospitals wrote. 

"The inability to secure adequate quantities of any of these components will result in lower testing capacity. The absence of certain components could result in testing machines sitting unused," they added.

For the country to begin easing out of the current social distancing restrictions, a massive increase in testing capacity is needed.

The Trump administration has touted new tests made available through the Food and Drug Administration's emergency-use authorization process because they are designed to run on machines that many labs already own.

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During recent White House briefings, Birx has specifically mentioned a test manufactured by Abbott that runs on the m2000 machine. 

The point-of-care test is meant to deliver results in hours, as opposed to days. Once a patient sample is collected, it can be tested on-site, rather than shipped off to a large commercial lab.

On Monday, Birx said Abbott sent a million tests to labs across the country but that only 250,000 have been used in three weeks' worth of work and that 75 percent of the machines were not being used.

"And that's why we've really been appealing to the laboratory directors to really bring those machines on," Birx said.

But the hospitals said the answer to increasing capacity is more complicated than merely turning on unused machines. They expressed those concerns to Birx during calls last week. 

According to Abbott, there are about 200 m2000 machines in hospitals, academic centers and reference labs throughout the U.S. 

Many labs have only one machine, and under perfect circumstances with adequate testing supplies, those machines can run 470 tests per day and get results in about six hours.  

"Maximum capacity is still probably not a sufficient number of tests," Heather Pierce, the AAMC’s senior director for science policy and regulatory counsel, said in an interview. "So we'll still need more, even if it's running at capacity."

Pierce said she has heard from labs trying to purchase parts, reagents or test cartridges from the manufacturers that either the federal government or other laboratories have been given higher priority.

The AAMC urged the administration to take a "more definitive role in understanding and managing" the testing environment and to be more transparent in their communication.

If commercial vendors are directed or permitted to provide materials to some labs preferentially over others, "this information should be readily available to both commercial partners and all labs," the group wrote, so lab directors can focus their time and resources on obtaining whatever supplies are available to them.