• As LabCorp and Quest are struggling to meet the growing demand for molecular diagnostics amid the growing number of coronavirus cases, Brett Giroir, head of the federal COVID-19 testing effort, said the Trump administration is waiting for a quick point of care testing by Abbott, BD and Quidel can relieve the pressure.
• Giroir reiterated comments made by the lab giants themselves, admitting at a press conference on Tuesday that commercial labs have longer lead times for test results and the extent of their capabilities. To solve the problem, he pointed out that Abbott’s BD and Quidel antigen-based POC tests, as well as Abbott’s ID Now molecular test, can be performed outside of lab settings in minutes rather than days.
• Although some molecular tests, such as Abbott’s ID Now, provide a rapid response, antigen tests are believed to be more suitable for obtaining rapid results. A Quest spokesperson told MedTech Dive Wednesday that “molecular diagnostic tests still have value.” At the same time, he said the company is “looking into the possibility of starting its own antigen test.”
While LabCorp and Quest prioritize testing for inpatients, preoperative acute care patients, and symptomatic healthcare professionals, test turnarounds are generally increasing at some of the major commercial labs for more people, according to Giroir.
“On average, we have two states with a delivery time of four to five days, 24 states with three or four days, and the other states between two and three days.
A LabCorp spokesperson told MedTech Dive on Wednesday that response times for test results would remain unchanged from a June 30 statement that it could take an average of one or more days due to the recent increase in disease. Two more days to see results. “It would be fair to say that the current response time is on average 2 to 4 days across the country,” the spokesman said.
The quest to annoncé dans joins mise à jour des tests Lundi soir that the demand for molecular diagnostic tests across the country, in particular in the south, the south-west and the west, then crore, “dépassant” I enabled her of the company.
Giroir described that the labs did not reach their maximum testing capacity, but cautioned that they were “pushing the limits,” which is why he says POC testing is important.
Quidel announced the first class of EUA antigens in May, while the company adopted Abbott’s POC test in late March.
Giroir said the point-of-care market is valued at between 10 and 20 million monthly tests between August and September.
At the same time, he noted that rapid POC tests “are a little less sensitive than laboratory tests.” As a result, if a doctor has “very high suspicions of someone with COVID,” he has advised that “a negative test should be repeated with a laboratory test.”
This is a similar recommendation from the FDA last month, which noted that while molecular testing is generally very accurate and generally does not need to be repeated, negative antigen test results may need to be confirmed by molecular testing. In particular, the agency said antigen testing could not definitively rule out an active coronavirus infection.
Your doctor may recommend a molecule test if your antigen test shows poor results but you have COVID-19 symptoms,” according to the FDA.
However, the FDA has also reported the accuracy of Abbott’s ID Now Rapid Test. In May, the agency addressed the “possible inaccurate results” of the POC test and responded to a study that linked ID Now with a higher false-negative rate than competitive tests. As a result, Abbott has changed the instructions for sample collection and handling and has agreed to conduct post-marketing studies.