Dive Brief:

• As LabCorp and Quest struggle to keep up with increased demand for molecular diagnostics amid a surge in coronavirus cases, Brett Giroir, lead for federal COVID-19 testing efforts, said the Trump administration is hoping rapid point-of-care tests from Abbott, BD and Quidel can alleviate the pressure.    
• Echoing comments from the lab giants themselves, Giroir acknowledged in a Tuesday press call that the commercial labs are currently experiencing longer turnaround times for test results and reaching capacity. To address the problem, he touted the ability of antigen-based POC tests from BD and Quidel, as well as Abbott's ID Now molecular test, to be performed outside of lab settings in minutes rather than days.  
• Although some molecular tests, such as Abbott's ID Now, offer quick turnaround, antigen tests are believed to be better suited for rapid results. A Quest spokesperson on Wednesday told MedTech Dive that "there remains value in molecular diagnostic testing." At the same time, she said the company is "exploring the option to launch its own antigen test."

Dive Insight:

While LabCorp and Quest are prioritizing testing for hospitalized patients, pre-operative patients in acute care settings and symptomatic healthcare workers, Giroir said the test turnaround times at some of the large commercial laboratories are generally increasing for other individuals.

"On average, we have two states that those turnaround times are between four and five days, 24 states with three to four days, and the rest of the states are between two and three days," Giroir told reporters on Tuesday's media call.

A LabCorp spokesperson on Wednesday told MedTech Dive its turnaround times for test results remain unchanged since a June 30 statement reporting that due to the recent increase in demand for testing results it may on average take one to two days longer to get results. "Would be fair to say that current turnaround time is 2-4 days on average nationwide," the spokesperson said.  

Quest in a testing update late Monday said demand for its molecular diagnostic tests has continued to rise across the country, particularly in the South, Southwest and West, and is "outpacing" the company's capacity.

"The average turnaround time for reporting test results is now 1 day for priority 1 patients and 4-6 days for all other populations. We are doing everything we can to bring more COVID-19 testing to patients in the United States at this critical time," said Quest's statement.

Giroir described the labs as not reaching their maximum testing capacity but warned that they are "pushing the frontiers" which is why he contends POC tests are important.

The emphasis on point-of-care testing comes on the heels of BD's announcement on Monday that FDA granted emergency use authorization to its rapid POC antigen test. Quidel claimed the antigen category's first EUA in May, while Abbott's quick-turnaround molecular POC test got the agency's nod in late March.    

Giroir said that between August and September, he estimates the point-of-care market to be between 10 and 20 million tests monthly.

At the same time, he emphasized that the rapid POC tests are "a little bit less sensitive than a laboratory-based test." As a result, he advised if a healthcare provider has a "very high suspicion of a person having COVID" then "a negative test should be repeated by a laboratory test."

It's a similar recommendation made last month by the FDA, which noted that although molecular tests are typically highly accurate and usually do not need to be repeated, negative results from antigen tests may need to be confirmed with a molecular test. In particular, the agency said antigen tests are not able to definitively rule out active coronavirus infection.

"Antigen tests are more likely to miss an active coronavirus infection compared to molecular tests. Your healthcare provider may order a molecular test if your antigen test shows a negative result but you have symptoms of COVID-19," according to the FDA.

However, the accuracy of Abbott’s rapid ID Now point-of-care test has also been flagged by FDA. In May, the agency addressed "potential inaccurate results" by the POC test, responding to a study that linked ID Now to a higher rate of false negatives than rival tests. As a result, Abbott changed its sample collection and handling instructions and agreed to conduct postmarket studies.