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03/29/2021

BGI Obtains CE Mark for Two SARS-CoV-2 Mutant Detection Kits



BGI Genomics Co. LTD., today announces that its Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR*), and the Detection Kit for six mutations in S gene of SARS-CoV-2 (ARMS-PCR*) get the CE Mark.

The two kits developed by BGI PathoGenesis Pharmaceutical Technology Co., Ltd., a subsidiary of BGI Genomics, enable rapid identification and monitoring of new variants. The Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2 (Fluorescence RT-PCR) can identify the B.1.1.7 and B.1.351 lineages, whereas the Detection Kit for 6 mutations in S gene of SARS-CoV-2 (AMRS-PCR) enables the identification of wild-type and mutant coronavirus virus strains by detecting spike protein mutations (N501Y, A570D, HV69-70del, K417N, K417T and E484K).

B.1.1.7, B.1.351 and B.1.1.28 variants have been found in many countries. They have N501Y mutations in the receptor-binding domain (RBD) of the spike protein on the surface of the virus, making it easier to bind to the angiotensin-converting enzyme 2 (ACE2) receptor on the human cell surface. The RBD mutations in these variants also include A570D, HV69-70del, K417N, K417T and E484K mutations.

Since the outbreak of COVID-19, the evolution of SARS-CoV-2 has been one of the focuses of public attention. These two CE marked kits will facilitate the rapid identification and global surveillance of new SARS-CoV-2 variants.

 

*RT-PCR: reverse transcriptase—polymerase chain reaction
*ARMS-PCR: amplification refractory mutation system—polymerase chain reaction
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