Bio-Rad Laboratories, Inc., a global leader of life science research and clinical diagnostic products, has 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.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology and pharmaceutical companies, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with approximately 7,800 employees worldwide. Bio-Rad had revenues exceeding $2.5 billion in 2020.