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樂普醫療(300003.SZ):新冠抗原(SARS-COV-2)檢測試劑盒(膠體金免疫層析法)入圍出口“白名單”
格隆匯 11-09 16:10

格隆匯 11 月 9日丨樂普醫療(300003.SZ)公佈,公司旗下子公司北京樂普診斷科技股份有限公司(“樂普診斷”)始終致力於IVD域產品的研發與製造日獲悉,自主研發的抗原檢測試劑盒入圍出口“白名單”,這是繼20203月自主研發的新型冠狀病毒(SARS-CoVer-2)抗體檢測試劑盒後再一次取得歐盟市場市場準入資格

抗原檢測試劑盒不同於抗體檢測試劑盒,而是用於定性快速檢測臨牀樣本(鼻拭子)中的新冠狀病毒(SARS-CoV-2)抗原,採用特異性的抗體抗原反應及免疫分析技術,檢測盒含有預先包被在結合墊上的金標新型冠狀病毒N蛋白單克隆抗體以及固定於測試區(T)的配對新型冠狀病毒N蛋白單克隆抗體和質控區(C)的相應抗體,以達到對新型冠狀病毒感快速更精準檢測。同時,新冠抗原(SARS-COV-2)檢測試劑盒已經通過巴基斯坦伊斯蘭堡診斷中心臨牀驗證,診斷靈敏度為97.47%,診斷特異性為95%,測試結果表現良好。

“白名單”的入圍將為全球新冠肺炎的疑似患者、隔離或醫學觀察和其他需要進行新型冠狀病毒感染診斷或鑑別診斷者提供更加快速、準確、便捷的現場檢測手段。樂普診斷將加大生產力度,積極保障產品的安全性和有效性,為抗擊全球新冠疫情反覆積極做好準備,為人類健康事業做出貢獻。

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