May 10, 2020, BGI Europe A/S, a subsidiary of BGI Genomics today announced that its Real-time fluorescent RT-PCR kit for detecting 2019-nCoV was listed in the World Health Organization Emergency Use Listing (EUL).
On January 30, 2020, WHO declared the outbreak of COVID-19 to be a public health emergency of international concern, and initiated EUL for In vitro diagnostics (IVDs) Detecting SARS-CoV-2 Nucleic Acid. There are five SARS-CoV-2 detection kit providers listed in WHO’s EUL till now. Among them, BGI is the first Chinese company to be listed in EUL as qualified provider of WHO’s in vitro diagnostic procedures.
BGI’s highly-sensitive RT-PCR testing kit, which can return results within three hours, detects the RNA of SARS-CoV-2 extracted from a wide range of respiratory samples. It features
- High sensitivity: Limit of detection as low as 100 viral copies/mL
- High specificity: No cross-reactivity with 54 human respiratory pathogens
- Ease to use: All-inclusive with pre-mixed reaction reagents
- Easy interpretation: Analysis of one target with well-defined controls
“BGI’s RT-PCR kit is one of the most widely recognized molecular products for SARS-CoV-2 detection by global regulatory agencies,” said Yin Ye, CEO of BGI Genomics. “It is another testament to our strong commitment to enabling safe and effective COVID-19 testing on a global scale.”
BGI’s RT-PCR Test for Detecting SARS-CoV-2 is one of the most reliable and widely used testing methods available, with over 20 million tests already performed, covering more than 80 countries and regions around the world. In 2020, BGI’s testing kit for SARS-CoV-2 received emergency approval from China’s National Medical Products Administration (NMPA), followed by the European CE mark, the U.S. FDA Emergency Use Authorization (EUA), Japan’s PMDA approval, Australia’s TGA approval, and Health Canada Authorization.
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