Covid-19 Test Bio-Rad Launches Sars-Cov-2 RT-PCR Assay Kit in Europe

Bio-Rad Laboratories announced the launch of the Reliance Sars-Cov-2 RT-PCR Kit (IVD) for European markets after having met the CE-IVD mark requirements.

Hercules/USA — The Reliance Sars-Cov-2 RT-PCR Kit from Bio-Rad 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. The kit has now been made available in Europe. 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.

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