凱普生物(300639.SZ):新型冠狀病毒(2019-nCoV)核酸檢測試劑盒已於今日完成註冊抽樣工作
格隆匯2月3日丨凱普生物(300639.SZ)公佈,公司全資子公司潮州凱普生物化學有限公司和廣州凱普醫藥科技有限公司研發團隊應用熒光PCR技術和Sanger測序平台,在春節期間完成研發攻關工作,分別完成了新型冠狀病毒(2019-nCoV)核酸檢測試劑盒(PCR-熒光探針法)和新型冠狀病毒2019-nCoV核酸檢測試劑盒(Sanger測序法)的開發。新型冠狀病毒(2019-nCoV)核酸檢測試劑盒(PCR-熒光探針法)主要用於檢測2019-nCoVORF1ab基因和2019-nCoVN基因,同時以人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。新型冠狀病毒2019-nCoV核酸檢測試劑盒(Sanger測序法)可檢測2019-nCoV病毒9個基因。在兩個平台開發產品,即可滿足臨牀快速檢測的需要,也可對病毒感染情況做更全面的檢測,確保結果的準確性。
上述產品僅用於對新型冠狀病毒的檢測,不用於治療,已於今日完成產品的註冊抽樣工作。公司已向藥品監督管理部門提出醫療器械應急審批申請,是否取得醫療器械註冊證書尚具有不確定性。上述產品非公司獨家產品,銷售情況取決於此次疫情的防控情況,具有不確定性,敬請廣大投資者注意投資風險。
作為公司第三方檢驗的旗艦,公司控股的廣州凱普醫學檢驗所已作為廣東省衞健委指定的承接新型冠狀病毒樣本檢測的第三方檢驗機構之一,開展相關的樣本檢測工作。武漢凱普醫學檢驗實驗室有限公司已被湖北省新型冠狀病毒感染肺炎疫情防控指揮部列入可開展新型冠狀病毒核酸檢測的第三方機構名單(第一批)。公司在全國各地建立的第三方醫學檢驗實驗室也將做好相關準備工作,根據當地醫療機構的檢測需求和政策安排,為加強當地新型冠狀病毒的核酸檢測工作出力,為做好新型冠狀病毒的防控工作盡一份力量。
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