Through the Exact Diagnostics product line, Bio-Rad Laboratories has released a SARS CoV-2 Standard to support laboratory assay validation of COVID-19 testing. By providing this standard, Bio-Rad aims to assist laboratories in validating their COVID-19 assay results and accelerate access to testing.
The SARS CoV-2 Standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, enabling laboratories to the entire process of a molecular assay. The Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards require clinical laboratories to document and establish their performance specifications for their developed tests. This documentation of performance specifications helps ensure accurate results before testing.
Bio-Rad Executive Vice President, Dara Wright, said, “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.”