Date: 03/12/2020
HERCULES, Calif. – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today 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.
“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.”
Bio-Rad’s Exact Diagnostics product line is a leader in developing and manufacturing a broad range of innovative molecular diagnostics products designed to meet the quality control needs of clinical labs and assay manufacturers. By providing quality products and services to clinical laboratories and manufacturers, these products enhance patient care by helping to ensure the validity of diagnostic and screening tests results. For more information, please visit exactdiagnostics.com.
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