High-level questions about the performance of an Abbott (NYSE:ABT) device used to test samples for COVID-19 arose again yesterday.
During Monday’s White House coronavirus briefing, Vice President Mike Pence said there is enough testing capacity within the country to begin phase one of President Donald Trump’s plan to reopen the economy — a notion that some state governors disagree with. Dr. Deborah Birx said that there are 5,000 testing machines available in the U.S. to conduct COVID-19 tests, with most deployed in more heavily populated areas and coronavirus hot spots such as New York City and northern New Jersey.
Birx showed a slide depicting four different types of specimen testing machines with varying capacities and speeds in delivering results. One of them, the Abbott ID Now, can test one specimen at a time, prompting Gov. Jared Polis of Colorado to note its limitations during a separate press conference.
Polis said the Abbott machine has two limitations, according to a report by Bloomberg News.
“One, it’s generally believed to have a lower accuracy rate, just to integrate that into how you use it,” Bloomberg quoted Polis as saying. “But the bigger one is we simply have plenty of the machines but we don’t have the tests. Only Abbott sells them. It’s proprietary. I think we’ve gotten 200. We need thousands every week.”
Polis added that Abbott is selling tests to the Federal Emergency Management Agency and not directly to states, Bloomberg reported.
Most Abbott customers are running COVID-19 tests on the company’s m2000 RealTime lab instruments, but some are not running them at capacity, Abbott spokeswoman Kimberly Modory told MassDevice in an email Wednesday morning.
“We understand that some are running other tests, some are working to increase staff and their supplies, some don’t have COVID-19 samples to run,” Modory said. “In some instance, states and cities are working to establish ways to transport samples to labs that have capacity.”
Birx said on April 8 that U.S. laboratories are not running enough COVID-19 diagnostic tests using m2000 machines. At the time, Birx said that 80% of the Abbott machines in 120 laboratories across the country are not running, despite the availability of 1 million tests. Abbott said in March, when it received FDA emergency use authorization for a coronavirus test, that each of the more than 175 m2000 systems in U.S. labs can run up to 470 tests in 24 hours.
Other actions in phase one of Trump’s plan, outlined by Brad Smith, deputy administrator and director of the Center for Medicare & Medicaid Services (CMS), include:
- Invoking the Defense Production Act to require Puritan Medical (Guilford, Maine) to manufacture 20 million test swabs per month for suspected COVID-19 patients. The government contract would “help them build four new production lines,” Smith said . “They are currently the largest swab producer in the country, and this will help them ramp up their production tremendously.” Smith did not specify the size of the contract. Puritan’s website says it is one of only two manufacturers in the world of nasopharyngeal flocked swabs.
- Helping an unnamed Ohio company that manufactures the largest number of Q-tips in the U.S. to convert its line to making test swabs. The company will ultimately be able to produce 10 million swabs a month, Smith said. Unilever, which owns Q-tips, did not respond to a request for comment.
- Working with Oak Ridge National Laboratory in Tennessee, which Smith said has “very unique and sophisticated injection molding manufacturing capability,” to produce more than 40 million test sample collection tubes “over the next several weeks.”
- Securing 17 million lancets for finger-stick serological testing and the same number of alcohol swabs to disinfect the finger before specimen collection. Government officials have been discussing how serological testing, which is designed to detect immunity to certain diseases, will be important in determining who has already had COVID-19 and may have immunity.
- More than 650,000 infrared thermometers that states and businesses will be able to access to test people as they come to work.
“So I think we’ve made tremendous progress on the collection side,” Smith said.
This article has been updated with comments from Abbott.
