Bio-Rad Labs launches SARS CoV-2 testMarch 19, 2020
Bio-Rad Laboratories, Inc, has launched a SARS CoV-2 Standard through its Exact Diagnostics product line to support laboratory assay validation of coronavirus (COVID-19) testing.
The SARS CoV-2 standard contains synthetic COVID-19 RNA transcripts and human genomic DNA, that can help laboratories validate their COVID-19 assay results. The standard allows the laboratories to test the entire process of a molecular assay including extraction, amplification, and detection of the virus.
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.