LabCorp, Burlington, NC, announced it is the first commercial laboratory to receive an emergency use authorization (EUA) from the FDA for a new, high-throughput method that uses heat and technology to extract RNA from samples collected for covid-19 molecular testing. The advancement will help the company improve the speed and efficiency of RT-PCR tests, considered the ‘gold standard’ for active infections.1
“Innovation and scientific advancements will ultimately resolve this public health crisis,” says Marcia Eisenberg, PhD, chief scientific officer of LabCorp Diagnostics. “We are constantly evaluating new technologies and methods to improve the testing process, and we are excited to pioneer and introduce RNA-extraction free methodology in our laboratories, and to the diagnostic community at large.”
The innovative heat extraction process, which has comparable sensitivity to current extraction methods, traps viral particles, eliminating the need for RNA extraction reagents to capture and concentrate viral nucleic acid. This substantially improves testing efficiency and decreases LabCorp’s reliance on testing supplies, streamlining resources and further reducing the time needed to complete and report results for molecular tests. The method adds to other LabCorp molecular testing innovations, such as its short nasal swab for at-home collection, which is easier to use and more comfortable for patients. LabCorp’s current average result delivery time for covid-19 molecular tests is 24 hours.
The company also announced that it is the first commercial laboratory to receive an FDA EUA for the use of matrixed pooling on samples collected outside a healthcare setting via its Pixel by LabCorp and LabCorp At Home covid-19 test collection kits. The matrixed pooling authorization for at-home collection is an extension of the FDA EUA issued on July 24, which allows LabCorp to test larger groups of samples at one time on samples collected by a healthcare professional. Pooling allows for increased testing capacity and can quickly provide quality test results for individuals within the group, without requiring retesting in the majority of cases. Pooled testing may be used for populations at low risk of covid-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.
LabCorp has performed over 15 million molecular tests since first making the covid-19 test available in March and is now able to process 200,000 tests per day with plans to increase capacity further.
For more information, visit LabCorp.
1 Centers for Disease Control and Prevention, Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 Using Antigen Tests, September 4, 2020.