Bioneer received CE-IVD mark for Its Multiplex Assay of COVID-19 and Influenza (Nov 18, 2020)
관리자 / 2022-09-01
On November 11th, Bioneer received CE-IVD marking for its newly launched molecular diagnostic kits, ‘AccuPower® RV1 Real-Time RT-PCR Kit’ and ‘AccuPower® RV1 Multiplex Kit’, that can diagnose both COVID-19 and influenza.
AccuPower® RV1 Real-Time RT-PCR Kit is customized to Bioneer’s automated molecular diagnostic system, and AccuPower® RV1 Multiplex Kit is compatible with other PCR equipment in the market.
The Bioneer’s AccuPower® RV1 kits use a single sample to detect COVD-19 (E gene, RdRp & N gene) and Influenza A/B, resulting in much faster test results than separately testing each sample.
At the early stage, symptoms of COVID-19 and Influenza are very similar yet caused by completely different viruses. Therefore, accurate and timely testing results are important to treat each disease.
There are many reports that COVID-19 viruses are mutating constantly. Although COVID-19 vaccines and treatments are ready to be launched in near future, patients cannot be diagnosed only by their symptoms. It is inevitable that PCR testing is necessary not only to diagnose the patients properly but to minimize any confusion or possible collapse in medical and quarantine systems in many countries around the world.
Bioneer is the only company in South Korea to provide a total solution to the molecular diagnostic system. The company manufactures and supplies nucleic extractor, preparation kit, Real-time PCR equipment, and PCR kits, the four major products that require in molecular testing, to over 80 countries in the world.
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About the Multiplex Assay for Flu and COVID-19
Bioneer received CE-mark certification for the Multiplex Assay for Flu and COVID-19.
It is an in vitro diagnostic kit that helps diagnose COVID-19 & Influenza infections. The kit is able to detect 5 targets about COVID-19(E gene, RdRp & N gene) and Influenza A/B in a tube.
It leverages the company’s original patented technology Dual-HotStart™. It can detect RNA target from clinical samples with high sensitivity and specificity through eliminating non-specific synthesis and amplification.
About BIONEER Corporation
Established in 1992, BIONEER is the first Korean biotechnology company and is publicly traded at KOSDAQ since 2005.
Bioneer has developed state-of-the-art molecular biology products and technologies over the years, including oligonucleotides, thermostable polymerases, and unique dual hot starter PCR system together with DNA/RNA synthesizer, automatic nucleic acid extractor, thermal cycler and real-time PCR instruments. Bioneer’s popular MDx system ExiStation™ offers an efficient, automated, and pipetting-free system that minimizes hands-on steps from nucleic acid extraction to PCR processes. ExiStation™ is equipped with an aerosol protection system to prevent contamination and secondary infection by users and provides an accurate test result.