Bio-Rad Launches SARS CoV-2 Standard for Coronavirus (COVID-19) Testing

By LabMedica International staff writers
Posted on 02 Dec 2020

Bio-Rad Laboratories, Inc. (Hercules, CA, USA) has launched a SARS CoV-2 Standard through its Exact Diagnostics product line 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.

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"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."