邁克生物(300463.SZ):完成研發3種新冠病毒檢測試劑盒
格隆匯2月21日丨邁克生物(300463.SZ)公佈,為積極響應新型冠狀病毒感染肺炎疫情防控的需求,公司及時開展相關檢測試劑盒的研發工作,並針對疫情需求,開發了新冠狀病毒核酸檢測試劑、新冠病毒特異抗體IgG和IgM檢測試劑。截止目前,公司已完成新型冠狀病毒(2019-nCoV)核酸三重檢測試劑盒、新型冠狀病毒IgG和IgM抗體檢測試劑盒(直接化學發光法)、新型冠狀病毒(SARS-Cov-2)IgG/IgM抗體檢測試劑盒(膠體金法)的研發工作。
其中,新型冠狀病毒(2019-nCoV)核酸三重檢測試劑盒已進入應急審批通道;新型冠狀病毒IgG和IgM抗體檢測試劑盒(直接化學發光法)、新型冠狀病毒(SARS-Cov-2)IgG/IgM抗體檢測試劑盒(膠體金法)目前正在臨牀驗證中。
公司已啟動應急審批申報工作,具體進展待國家藥品監督管理局決定。公司將密切關注產品研發、註冊進展情況,及時履行信息披露義務,請廣大投資者注意投資風險。
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