Bio-Rad Laboratories has launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus (COVID-19) testing.
Bio-Rad launched its SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing, the company said in a statement.
The federal government’s Clinical Laboratory Improvement Amendments (CLIA) 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.
The standard is part of Bio-Rad’s Exact Diagnostics product line.
“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 manufactures a line of quality-control products in molecular diagnostics for clinical labs and assay manufacturers.
