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華大基因(300676.SZ):子公司兩項新冠檢測產品獲得CE准入資質
格隆匯 02-10 17:02

格隆匯 2 月 10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(以下簡稱華大因源)研製兩項新型冠狀(以下簡稱新冠)病毒檢測產品於近日獲得歐盟CE准入資質情況如

202012,英國向世界衞生組織通報出現新的B.1.1.7新冠病毒相關科學研究表明變異病毒傳播能力比原始毒株更高快速對B.1.1.7新冠變異病毒作出鑑定成為各國疫情防控工作重點之一本次獲得CE准入資質第一項產品病毒B.1.1.7突變快速檢測試劑盒(ARMS-PCR法)採用擴增阻滯突變PCR實現野生型病毒株(501N681P)和突變型病毒株(501Y681H)的鑑別診斷從而有利於新冠病毒變異監測

公司此次獲得CE准入資質的項產品快速核酸檢測試劑盒(PCR熒光探針法)採用體外PCR擴增和熒光探針相結合的方法,針對病毒2019-nCoV的高度保守區域以及內參基因設計熒光檢測的特異性引物探針。該試劑盒通過採用快速生化反應模式,縮短了檢測時間從而有利於提高新冠病毒檢測的效率

根據歐盟《體外診斷醫療器械指令》規定,華大因源研製病毒B.1.1.7突變株(N501YP681H)快速檢測試劑盒(擴增阻滯突變PCR法)新冠病毒快速核酸檢測試劑盒(PCR熒光探針)產品已經成了CE申報,並得到了主管機構的確認,這兩項檢測產品已具備歐盟市場的准入條件。

上述產品獲得CE准入資質於進一步豐富公司新冠病毒檢測產品矩陣,增強公司新冠病毒檢測產品的綜合競爭力,滿足多種應用場景的牀需全面助力新冠疫情防控工作。上述產品實際銷售情況取決於新疫情防控涉及的檢測需求,公司目前尚無法預測其公司未來業績的影響

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