The CFX96 Dx real-time PCR system from Bio-Rad Laboratories, Hercules, Calif, has been listed with FDA for in vitro diagnostic (IVD) testing and may be used to help in the diagnosis of covid-19. The agency’s listing extends access to the instrument to molecular diagnostics developers and testing laboratories in the United States.
Throughout the covid-19 pandemic, the CFX96 Dx real-time PCR system has been used by laboratories outside the United States that require an IVD platform to detect SARS-CoV-2. The system has also met CE mark requirements for IVD use in Europe, and is registered with regulatory bodies for IVD use in many other countries.
“We are pleased our CFX96 Dx real-time PCR system is now available for covid-19 testing in US markets,” says Annette Tumolo, executive vice president of the life science group at Bio-Rad Laboratories. “By identifying those who test positive for the virus, individuals can be quarantined and receive treatment more quickly, helping to contain the spread of this disease.”
The CFX96 Dx real-time system joins other Bio-Rad products that are being used for the detection of covid-19, including the company’s SARS-CoV-2 droplet digital PCR kit; Platelia SARS-CoV-2 total antibody assay; and the SARS-CoV-2 standard, which is used to support assay validation for laboratory covid-19 testing.
For more information, visit Bio-Rad Laboratories.