美康生物(300439.SZ):完成兩款新型冠狀病毒檢測產品研製
格隆匯2月3日丨美康生物(300439.SZ)公佈,公司於近日完成了兩款新型冠狀病毒檢測產品的研製,具體情況如下:
公司研發的新型冠狀病毒核酸檢測試劑盒,採用實時熒光定量PCR技術,以2019-nCoV新型冠狀病毒的高度特異性序列為靶區域,設計特異性引物和TaqMan熒光探針,通過多重熒光PCR擴增,配套相關具有國家藥品監督管理局批准的產品註冊證書的實時熒光定量PCR分析儀,實現對2019-nCoV新型冠狀病毒RNA的檢測,最快2個小時可出檢測結果。
公司研發的新型冠狀病毒蛋白快速檢測試劑盒,採用免疫層析法,是一種POCT快速檢測方式。此方法通過分別標記在納米顆粒上和固定在硝酸纖維膜檢測區帶上的特異性抗體,與樣本中的新型冠狀病毒蛋白抗原形成雙抗體夾心的免疫反應,並運用納米顆粒的顯色作用,從而實現對特異性的新型冠狀病毒蛋白的定性檢測。該產品主要用於醫療機構對新型冠狀病毒的初步快速篩查,最快10分鐘可出結果。
公司表示,上述產品尚處於公司臨牀驗證階段,臨牀驗證的結果符合相關檢測標準,公司將提交樣品及相關資料向國家藥品監督管理局進行註冊申請,能否取得醫療器械註冊證書及取得註冊證書的時間具有不確定性。
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