Saturday, 06 June 2020


Bio-Rad receives FDA EUA for Droplet Digital PCR SARS-CoV-2 test kit

06 May 2020 | News

Test runs on Bio-Rad’s QX200 and QXDx ddPCR systems

Image credit- shutterstock.com

Image credit- shutterstock.com

Bio-Rad Laboratories Inc, a global leader of life science research and clinical diagnostic products, has announced that its SARS-CoV-2 Droplet Digital PCR (ddPCR) test kit has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The SARS-CoV-2 Droplet Digital PCR (ddPCR) test runs on Bio-Rad’s QX200 and QXDx ddPCR systems.

The high sensitivity of the test makes it well suited to screening 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.

The test can also play an important role in surveillance by detecting minimal residual disease in people recovering from COVID-19 informing them if they are negative for the virus. Bio-Rad’s single-well SARS-CoV-2 ddPCR test provides clinicians with a high degree of sensitivity that can significantly improve the accuracy of reported results.


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