Bio-Rad Laboratories has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit.
Bio-Rad’s QX200 and QXDx ddPCR systems can be used to run the SARS-CoV-2 ddPCR test.
The high sensitivity of the test enables to screen upper respiratory samples in patients with a low viral load, including individuals in the early stages of infection as compared to classical quantitative PCR tests.
Bio-Rad’s SARS-CoV-2 ddPCR test plays a significant role in surveillance by identifying minimal residual disease in people recovering from Covid-19, helping to better know the negative status of the person.
The SARS-CoV-2 ddPCR test provides clinicians with a high degree of sensitivity to enhance the accuracy of reported results
The single-well SARS-CoV-2 ddPCR test offers clinicians with a high degree of sensitivity, which can better improve the accuracy of reported results.
Accurate testing of Covid-19 is a crucial component to control the global pandemic, as per the World Health Organisation (WHO).
Multiple hospitals and molecular testing labs in the US and across the globe installed Bio-Rad’s QX200 and QXDx ddPCR systems, which hold the capacity to efficiently conduct SARS-CoV-2 ddPCR testing.
Bio-Rad digital biology group senior vice president Simon May said: “We are pleased to receive Emergency Use Authorization for our SARS-CoV-2 ddPCR test that offers high sensitivity in detecting infection of Covid-19 at an early stage.
“We believe the test will be a powerful complement to current diagnostics, helping clinicians and public health officials accurately identify infected individuals in a timely manner. With the EUA, our test is now available to clinical labs in the U.S.”
Recently, Bio-Rad also secured EUA status from the FDA for its SARS-CoV-2 Total Ab serology test. It is claimed to be the first total antibody test that secured EUA status from the FDA.
Bio-Rad is engaged in the development, manufacturing, and marketing of a range of products for the life science research and clinical diagnostic markets.
