HERCULES, Calif.–May 04, 2021–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced the launch of the Reliance SARS-CoV-2 RT-PCR Kit (IVD) for European markets after having met the CE-IVD mark requirements. The Reliance SARS-CoV-2 RT-PCR Kit is a real-time reverse-transcription PCR (RT-PCR) test that can detect nucleic acid in SARS-CoV-2, the virus associated with COVID-19 disease. A version of the assay kit is also available in the United States under an U.S. Food and Drug Administration (FDA) emergency use authorization (EUA).
The Reliance SARS-CoV-2 RT-PCR Kit (IVD) is designed for clinical diagnostic labs that conduct COVID-19 testing. The assay kit offers the qualitative detection of two separate target regions in the nucleocapsid gene (N1 and N2 regions) of SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of being infected by COVID-19. Because they are designed to target the nucleocapsid gene, the assay’s performance is not affected by known coronavirus variants as determined by in-silico analysis. The assay kit contains Bio-Rad’s standard and negative molecular controls as well as assay reagents, and it is validated to run on Bio-Rad’s CFX96 Dx RT-PCR system, as well as RT-PCR systems from other manufacturers.
“We are excited about the European launch of our SARS-CoV-2 RT-PCR Kit (IVD), a reliable, sensitive, and accurate solution for COVID-19 testing,” said Steven Blakely, Bio-Rad Global Director of Marketing, Life Science Group, Gene Expression. “Testing laboratories worldwide use Bio-Rad’s RT-PCR systems for the detection of SARS-CoV-2. The assay kit is the latest addition to our COVID-19 offering of research and testing products, reflecting our ongoing commitment to helping in the fight against COVID-19,” he said.