Bio-Rad Reliance RT-PCR COVID assays granted EUA

Feb. 23, 2021–Bio-Rad Laboratories announced that its Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR assay kits were granted emergency use authorization by the FDA.

The multi-target Reliance SARS-CoV-2/FluA/FluB RT-PCR assay kit simultaneously detects and differentiates SARS-CoV-2, influenza A, and influenza B in a single multiplex reaction. The highly sensitive respiratory pathogen panel is intended for use with nasopharyngeal swabs and anterior nasal swabs. The kit includes Bio-Rad positive and negative molecular controls.

The Reliance SARS-CoV-2 RT-PCR assay kit is a multiplex test that targets two separate regions in the nucleocapsid gene (N1 and N2 regions) to ensure greater sensitivity and tolerance to potential mutations. The kit contains the company’s standard and negative molecular controls.

The assays are not affected by known coronavirus variants as determined by in-silico analysis, the company says. Both assays are validated to run on Bio-Rad’s CFX Opus 96, CFX96 Touch, and CFX96 Dx qPCR systems as well as qPCR systems offered by other manufacturers; the SARS-CoV-2 RT-PCR assay kit is also available on the CFX Opus 384 and CFX384 Touch systems.