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April 2020

SARS-CoV-2 Diagnostic Kit


BGI announces a US FDA-approved medical device, the real-time fluorescent RT-PCR kit for detecting SARS-2019-nCoV. Intended for the qualitative detection of SARS-CoV-2, the test is highly sensitive and can return results from bronchoalveolar lavage fluid (BALF) and throat swabs within 3 hours. Hospitals and reference laboratories can run the test on the Applied Biosystems 7500 Real-Time PCR System. BGI has produced more than 4.7 million tests with orders from 84 countries and regions. In addition, BGI has donated over 130,000 test kits, while third-party organizations have donated another 178,000 of BGI’s test kits. BGI’s novel coronavirus detection test now has global approvals through US FDA, Europe’s CE-IVD, China’s NMPA, and
Japan’s PMDA.


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