The testing method comprises up to five individual upper respiratory swab specimens per pool and 25 specimens per matrix
FDA grants EUA for LabCorp’s for Covid-19 sample pooling. (Credit: Belova59/Pixabay.)
US-based life sciences company LabCorp has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) to use matrixed pooled testing to detect Covid-19 infections.
The company’s matrixed pooled testing is a method that facilitates testing of large groups at one time.
The method would rapidly provide test results for individuals within the group, and prevents the need for retesting in most of the cases, said the company.
It involves testing up to five samples in a single run and an individual positive sample in the pool will be identified using the patterns detected by its robotic testing platform.
LabCorp said that is pooled testing method is capable of reducing the number of tests in specific populations, optimise laboratory testing supplies, and increase testing capacity.
LabCorp Diagnostics chief medical officer and president Brian Caveney said: “We believe science and technology are the best ways to beat the virus, and our matrixed pooled testing method is another way LabCorp is helping to respond to this health crisis.
“Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity. The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”
Pooled testing detects SARS-CoV-2 in upper and lower respiratory specimens
The FDA EUA allows the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of Covid-19, using a matrix pooling strategy.
The testing method comprises up to five individual upper respiratory swab specimens per pool and 25 specimens per matrix. The specimens are collected under supervision or by a healthcare provider using individual vials containing transport media.
LabCorp said that the negative results from the pooled testing should not be treated as definitive, where a patient’s clinical signs and symptoms are not consistent with negative result.
The company said that its Covid-19 molecular test was granted EUA by the US FDA only for the detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens.