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凱普生物(300639.SZ)子公司取得1項醫療器械註冊證書
格隆匯 03-12 18:07

格隆匯3月12日丨凱普生物(300639.SZ)公佈,公司的全資子公司潮州凱普生物化學有限公司近日取得國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證(體外診斷試劑)》,產品名稱為葡萄糖-6-磷酸脱氫酶基因檢測試劑盒(PCR+導流雜交法)。

葡萄糖-6-磷酸脱氫酶(G6PD)缺乏症是常見的一種遺傳性酶缺乏病,俗稱蠶豆病。由位於X染色體上的G6PD基因突變導致葡萄糖-6-磷酸脱氫酶合成缺陷引起。由於葡萄糖-6-磷酸脱氫酶是磷酸戊糖代謝途徑的限速酶,葡萄糖-6-磷酸脱氫酶缺乏症患者無法正常分解葡萄糖,在接觸到具氧化性物質時,如蠶豆、阿斯匹林、磺胺類藥物後可能出現急性溶血反應,出現黃疸、精神不佳,嚴重時會出現呼吸急速、心臟衰竭甚至休克,嚴重威脅生命。全世界約4億人受累。我國是本病的高發區之一,主要分佈在長江以南各省,以海南、廣東、廣西、雲南、貴州、四川等省為高。

本產品採用生物素標記的引物分別對G6PD基因突變區域進行特異性擴增,將擴增產物與固定在尼龍膜上的不同突變位點探針在導流雜交儀上進行導流雜交(flow-through hybridization),然後通過化學顯色對結果進行判讀,用於臨牀上酶活檢測低於閾值、接近閾值或者略高於閾值、有G6PD家族史等人羣的檢測,進行葡萄糖-6-磷酸脱氫酶(G6PD)缺乏症的輔助診斷。

上述產品註冊證的取得,滿足市場多樣化的需求,進一步豐富了公司的產品種類,提升公司的核心競爭力,符合公司“核酸99”的戰略規劃,將對公司未來的經營發展產生積極影響。

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