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華大基因(300676.SZ):子公司新冠抗原檢測產品獲得CE准入資質
格隆匯 02-04 20:34

格隆匯 2 月 4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)研製新型冠狀病毒(以下簡稱新冠)抗原檢測試劑盒(膠體金法)於近日獲得歐盟CE准入資質

抗原檢測是直接針對病毒中的特有蛋白質(即抗原)進行檢測,能夠在急性感染期快速檢出陽性病例,可以用於對疑似人羣進行早期分流和快速管理,是現有檢測方法的補充。

冬季流感頻發,新冠肺炎與季節性流感併發將對疫情防控增大難度,快捷高效的檢測手段對於防疫一線具有較為重要的作用抗原檢測產品因其快速、便捷的特性,可用於疑似人羣快速輔助診斷及重點人羣快速輔助排查,促進患者早期診斷與及時干預能較好地滿足各國疫情現場快速檢測防控需求,在全球範圍內助力新疫情防控工作。

根據歐盟《體外診斷醫療器械指令》規定,華大因源研製新冠抗原檢測試劑盒(膠體金法)產品已經完成了CE申報,並得到了主管機構的確認,檢測品已具備歐盟市場的准入條件。

上述產品獲得CE准入資質於進一步提升公司新冠檢測產品的國際競爭力拓展公司海外市場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冠疫情防控涉及的檢測需求,公司目前尚無法預測其對公司未來業績的影響。

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