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華大基因(300676.SZ):新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(熒光免疫層析法)獲得醫療器械註冊證
格隆匯 12-09 20:18

格隆匯 12 月 9日丨華大基因(300676.SZ)公佈,近日,公司控股子公司深圳華大因源醫藥科技有限公司研製的新型冠狀病毒抗原檢測試劑盒通過國家藥品監督管理局應急審批,獲得了醫療器械註冊證。

產品名稱:新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(熒光免疫層析法);註冊證編號:國械注準20203400940;註冊分類:III類;有效期至:2021年12月3日;預期用途:本產品用於新型冠狀病毒感染肺炎疑似人羣口咽拭子、鼻咽拭子樣本中新型冠狀病毒N抗原檢測。抗原檢測一般用於急性感染期,即疑似人羣出現症狀7天之內的樣本檢測。抗原檢測不能單獨用於新型冠狀病毒感染的診斷,應結合核酸檢測、影像學等其他診斷信息及病史、接觸史判斷感染狀態。抗原檢測的陽性結果可以用於對疑似人羣進行早期分流和快速管理,但陽性結果僅表明樣本中存在新型冠狀病毒N抗原,不能作為新型冠狀病毒感染的確診依據。陰性結果不能排除新型冠狀病毒感染,也不得單獨作為作出治療和疾病管理決定的依據。疑似人羣抗原陽性及陰性結果均應進行進一步的核酸檢測。本產品不得用於一般人羣的篩查。本產品應在專業實驗室由專業人員使用。

此次新冠抗原檢測產品獲批上市後,公司實現了新冠病毒核酸檢測試劑、抗體檢測試劑和抗原檢測試劑三類產品組合,技術覆蓋多樣,包括熒光PCR法、聯合探針錨定聚合測序法、酶聯免疫吸附測定法、膠體金法和熒光免疫層析法,可以滿足不同場景和用途的臨牀需求。上述產品獲批進一步豐富了公司感染防控業務產品線,提高了公司的市場競爭力,全面助力新冠疫情防控工作。

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