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The assays are based on the WHO reference methods.
April 28, 2020
By: PR Newswire
BIOTECON Diagnostics has developed and launched its own microproof SARS-CoV-2 Screening/Identification Kits, which are available immediately for purchase and can be distributed globally. In light of the pandemic outbreak reaching all corners of the earth, with millions of people infected and many fatalities, diagnostic testing has offered some respite in the midst of such unprecedented challenges. Germany alone carries out hundreds of thousands of PCR tests a week in the fight against the COVID-19 infectious disease. This trend of carrying out large-scale testing has proven effective in stemming the spread of the coronavirus in many of the hardest-hit countries. “I am extremely proud of our team of scientific researchers and experts, who in a short space of time have managed to develop, manufacture and market such high-quality real-time PCR tests for the qualitative detection of SARS-CoV-2. It is the latest addition to a whole coronavirus product portfolio we have aimed at expanding the availability of diagnostic testing and supporting the massively impacted healthcare systems,” commented Dr. Kornelia Berghof-Jäger, CEO of BIOTECON Diagnostics. “Our customers have depended on our fast and reliable real-time PCR technology for over twenty years. During times such as these, the kits from our German production facilities in collaboration with advanced automation solutions for all throughputs, such as the RoboPrep 32 and the KingFisher Flex, provide some of the best diagnostic tools available on the market to support the analysis of COVID-19,” commented Dr. Kornelia Berghof-Jäger. “We aim to support laboratories in the entire process of a molecular assay including automated high-throughput extraction, amplification, and detection of the virus. In addition to our own kits and analytical instruments, we have entered into agreements with several partners worldwide to be able to meet the growing demand for viral RNA extraction and identification of the coronavirus. Enhancing patient care by helping to ensure the validity of diagnostic and screening test results is what underlies all our efforts at present,” concluded Dr. Kornelia Berghof-Jäger. microproof SARS-CoV-2 Screening/Identification Kits are approved “for research use only” (RUO), CE-IVD pending. Approval from the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) pending. The assays are based on the WHO reference methods, adapted according to the Charité (Berlin, Germany) protocol for the detection of SARS-CoV-2.
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