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02/10/2021

Two COVID-19 Nucleic Acid Detection Kits of BGI Get CE Mark



BGI Genomics announces its Rapid Identification Kit for B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2(ARMS-PCR*) and Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method) have been CE marked. Both kits are manufactured by BGI PathoGenesis Pharmaceutical Technology Co. Ltd., a subsidiary of BGI Genomics.

The Rapid Identification Kit is a qualitative in vitro nucleic acid amplification assay to identify the B.1.1.7 lineage (N501Y and P681H) of SARS-CoV-2 in throat swab specimens or sputum that have been confirmed by RT-PCR to be SARS-CoV-2 positive. The kit will be able to identify mutant strains quickly and effectively, thus facilitating the global pandemic prevention and control.

The second kit obtaining the CE mark this time is the Rapid Nucleic Acid Detection Kit for 2019-nCoV (PCR fluorescent probe method). Compared with the kit which got CE mark last April, the new detection kit follows an optimized reaction procedure and can assist healthcare and medical institutions in different countries to effect timely and effective prevention in a shorter period of time.

In December 2020, the United Kingdom reported a new strain of SARS-CoV-2 lineage B.1.1.7, with data indicating that the new variant was highly infectious. The World Health Organization has recommended all countries should increase surveillance of new variants of COVID-19 to better understand the spread of the virus.

To date, BGI’s COVID-19 detection reagent has covered the nucleic acid detection kit, the antibody detection kit, the antigen detection kit and the mutant identification kit, which can meet the clinical needs of different applications.

 

*ARMS-PCR: amplification refractory mutation system-polymerase chain reaction

 

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