March 13, 2020—Bio-Rad announced it has launched, under its Exact Diagnostics product line, a SARS-CoV-2 standard to support laboratory assay validation of COVID-19 testing.
“In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests,” Dara Wright, Bio-Rad executive vice president and 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.”
The EDX SARS-CoV-2 Standard is manufactured with synthetic RNA transcripts containing E, N, and S genes that are each quantitated at 200,000 cp/mL using Bio-Rad digital droplet PCR. The product contains genomic DNA, allowing laboratories to validate for operator testing of the entire process of a molecular assay including extraction, amplification, and detection.