The newly developed Detection kit for COVID-19 (SARS-CoV-2) Omicron Variant nucleic acid test (fluorescent PCR method) is suitable for detecting the mutation sites of COVID-19 K417N, E484A, N501Y, N679K /P681H, and is used for primary screening and epidemiological surveillance of the COVID-19 mutant Omicron (B.1.1.529).

    On November 24, the National Institute of Infectious Diseases of South Africa reported a new COVID-19 Variant - B.1.1.529 to WHO for the first time, and on November 26, WHO officially announced that the Variant B.1.1.529 was designated as VOC (Variant of concern), and named it after the Greek letter ο (Omicron, Omicron). On November 29, WHO said that the overall risk assessment of COVID-19 Omicron variant in the world was "very high", which may be widely spread in the world.

    At present, confirmed cases infected with Omicron mutant has been found in 57 countries or regions such as South Africa and the United Kingdom. In South Africa, Omicron accounted for more than 80% of new cases in just 25 days, becoming the absolute dominant mutant strain there, with a faster rate of transmission compared to the previously emerged beta and delta mutant strains. On December 13, the Tianjin Municipal Health Commission announced the first case infected with Omicron Variant in mainland China, which was firstly detected in mainland China.

    The infectivity of SARS-CoV-2 depends mainly on the binding affinity of the RBD structural domain to the human ACE2 protein, and thus mutations in the RBD structural domain of SARS-CoV-2 can affect the infectivity of the mutant strain. Omicron carries 15 mutation sites in the RBD structural domain, including K417N, N501Y, and N440K. It was shown that the presence of K417N, E484A or N501Y mutations in the COVID-19 S protein suggested an enhanced immune escape ability.

    The Omicron mutant strain also has the H655Y + N679K + P681H mutation near the Furin cut site, which may also enhance viral replication and infectivity. The Delta variant, which is spreading across the globe, carries the P681R mutation near the furin cut site, and this mutation is thought to be one of the important reasons for the enhanced transmission of the Delta variant.