華大基因(300676.SZ)：子公司兩項新冠突變株檢測產品獲CE准入資質
格隆匯3月26日丨華大基因(300676.SZ)公佈，公司控股子公司深圳華大因源醫藥科技有限公司(華大因源)研製的兩項新型冠狀病毒突變株檢測產品於近日獲得歐盟CE准入資質。產品名稱分別為Rapid Identification Kit for B.1.1.7 lineage and B.1.351 lineage of SARS-CoV-2(FluorescenceRT-PCR)(中文譯文：新型冠狀病毒B.1.1.7和B.1.351突變株核酸檢測試劑盒(熒光PCR法))、Detection Kit for 6 mutations in S gene of SARS-CoV-2(AMRS-PCR)(中文譯文：新型冠狀病毒S基因6種突變檢測試劑盒(擴增阻滯突變PCR法))。
自新冠疫情爆發以來，新冠病毒本身的演進與突變是公眾關注的焦點之一。目前，已在多個國家發現B.1.1.7新冠變異株、B.1.351新冠變異株和B.1.1.28新冠變異株，它們在病毒表面刺突蛋白的受體結合域(RBD)發生了N501Y突變，使其與人體細胞表面的血管緊張素轉化酶2(ACE2)受體更容易結合。發生在這些新冠病毒突變株刺突蛋白RBD的突變還包括A570D、HV69-70del、K417N、K417T和E484K突變等。對新冠病毒變異株進行鑑定和監測已成為目前全球疫情防控工作的重點之一。
公司此次獲得CE准入資質的第一項產品新型冠狀病毒B.1.1.7和B.1.351突變株核酸檢測試劑盒(熒光PCR法)能定性鑑別新冠病毒B.1.1.7突變株和B.1.351突變株；第二項產品新型冠狀病毒S基因6種突變檢測試劑盒(擴增阻滯突變PCR法)可通過檢測新冠病毒刺突蛋白突變(N501Y、A570D、HV69-70del、K417N、K417T和E484K)實現野生型病毒株和突變病毒株的鑑別診斷。上述兩項試劑盒將有助於新冠病毒變異株的快速鑑定和監測。
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