Bio-Rad Laboratories, Hercules, Calif, through its Exact Diagnostics product line, 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.
Implementing regulations of the Clinical Laboratory Improvement Amendments of 1988 (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.
“In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests,” says Dara Wright, Bio-Rad executive vice president and president of the 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.”
For more information, visit Bio-Rad Laboratories.