Bio-Rad Laboratories has launched a new SARS-CoV-2 Standard, from its Exact Diagnostics product line, that will support laboratory assay validation of coronavirus (COVID-19) testing. Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.

The Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards require clinical laboratories to establish and document their own performance specifications for laboratory-developed tests to ensure accurate and precise results prior to the implementation of the test. The SARS CoV-2 Standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, allowing laboratories to test the entire process of a molecular assay including extraction, amplification, and detection of the virus.

"In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests," said Dara Wright, Bio-Rad Executive Vice President, President, Clinical Diagnostics Group. "The SARS CoV-2 Standard helps to validate COVID-19 tests, which enables more laboratories to meet the growing demand for identification of this coronavirus."