Dive Brief:

• More than 90% of the 1 million Abbott coronavirus tests delivered to laboratories have not been used because labs don’t have the resources to operate Abbott’s high throughput systems, the White House coronavirus response coordinator said Wednesday. “They're not running,” Deborah Birx said. “We've only run 88,000 tests in three weeks off of those machines, with a million test kits.”
• According to Abbott, 175 of its m2000 RealTime Systems are used in hospital and reference laboratories across the country. While these platforms can run up to 470 tests in a 24-hour period, the equipment is reportedly not being operated anywhere near its full capacity to help meet U.S. demand for COVID-19 testing.
• Abbott argued its systems are not the problem. “They are running, labs just need to expand volumes” by increasing staff and supplies, a spokesperson said in comments to MedTech Dive. However, labs nationwide are facing staffing issues and supply shortages hampering their abilities to perform the tests.  

Dive Insight:

Before Abbott began rolling out a rapid, point-of-care test, it announced March 18 that it received emergency use authorization from the FDA for its RealTime SARS-CoV-2 molecular test and would be cranking out the tests as quickly as possible.

But despite ramping up production, roadblocks to actually running the tests have emerged.

“These machines are every place in the country,” Birx said Wednesday. “They could have screened in these last three weeks 100% of the healthcare workers across the country that needed these tests to be done.”

Abbott on Wednesday said that a “majority” of the labs are running the COVID-19 tests based on communication with its customers.

“We understand that some of these labs are working to expand their capacity by increasing staff and supplies to run more shifts,” the company told MedTech Dive. “In some instances states and cities are working to establish ways to send the samples to the labs that have capacity.”

Birx said she was scheduled to speak later Wednesday with lab directors to discuss how they might resolve their issues with running tests on Abbott’s systems at full capacity.​  ​

For weeks, the American Clinical Laboratory Association​​ and its commercial lab members have expressed concerns​ about staffing issues and supply shortages that could hamper their abilities to conduct coronavirus tests.

ACLA President Julie Khani noted last week that while it is “working closely” with high-throughput platform manufacturers “that are essential to further expand testing capacity,” its members' labs “must have predictable and consistent access to swabs, personal protective equipment, test kits, reagents and other supplies necessary for testing.” However, Khani made no mention of Abbott or its m2000 system.

To ensure commercial labs have the equipment, supplies, staffing and resources they need, ACLA has asked the Department of Health and Human Services to immediately begin accepting applications from labs for a $100 billion fund created under the Coronavirus Aid, Relief, and Economic Security Act.

However, HHS has yet to release guidance on the application process or on how the agency will administer the CARES Act funds.