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凱普生物(300639.SZ):研發出新冠病毒COVID-19、甲型流感(FluA)及乙型流感(FluB)聯合核酸檢測試劑盒(熒光PCR法)
格隆匯 02-23 18:23

格隆匯2月23日丨凱普生物(300639.SZ)公佈,公司全資子公司廣州凱普醫藥科技有限公司研發團隊近期基於熒光定量PCR平台,通過封閉式、自動化、高通量的核酸提取和擴增系統,研發出“新冠病毒COVID-19、甲型流感(FluA)及乙型流感(FluB)聯合核酸檢測試劑盒(熒光PCR法)”。該試劑盒主要用於檢測甲型流感病毒、乙型流感病毒及新型冠狀病毒COVID-19。以人RNA內參B2M作為內參,用於監控樣本採集和提取效果,避免假陰性結果,設置UNG酶+dUTP防污染措施,避免PCR產物污染帶來的假陽性結果,採集後的樣本基於自動化核酸提取系統提取RNA,操作安全快捷,降低操作人員感染的風險。既可滿足臨牀快速檢測的需要,也可在抗擊新型冠狀病毒肺炎疫情的同時警惕季節性流感的疊加效應。

上述產品僅對新型冠狀病毒COVID-19、甲型流感病毒及乙型流感病毒RNA的體外定性檢測和鑑別,用於臨牀和篩查人羣的快速分流,不用於治療;該產品尚未取得醫療器械註冊證書,僅用於科研使用。上述產品是否能取得醫療器械註冊證書尚具有不確定性,敬請廣大投資者注意投資風險。

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