Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, has announced that through its Exact Diagnostics product line Bio-Rad has launched a SARS CoV-2 Standard to 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.