安科生物(300009.SZ):兩項精漿檢測試劑盒產品獲醫療器械註冊證(體外診斷試劑)
格隆匯1月7日丨安科生物(300009.SZ)公佈,2020年1月7日,公司取得安徽省藥品監督管理局核發的兩項精漿檢測試劑盒產品《醫療器械註冊證(體外診斷試劑)》(註冊證編號:皖械注準20202400001,皖械注準20202400002)。該兩項產品註冊證的獲得標誌着公司的新產品精漿果糖檢測試劑盒(吲哚法)、精漿中性α-葡糖苷酶檢測試劑盒(酶法)獲准上市銷售。
此次獲批的精漿果糖檢測試劑盒(吲哚法)臨牀用於體外定量檢測人精漿中果糖的含量,包裝規格為20人份/盒。精漿果糖是由血液中的葡萄糖在精囊中經酶促轉化產生並分泌的單糖,它是精囊所分泌的特徵性物質,是精子在精液中主要的糖類能源,直接參與精子的獲能和受精。測定精漿果糖可用於判定精囊腺功能。
此次獲批的精漿中性α-葡糖苷酶檢測試劑盒(酶法)臨牀用於體外定量檢測人精漿中性α-葡糖苷酶含量,包裝規格為20人份/盒。精漿中性α-糖苷酶由附睾分泌,此酶可催化多糖或糖蛋白中的碳水化合物分解為葡萄糖,為精子代謝和運動供能,其活性高低可直接影響精液質量。該酶活性低下可能是臨牀上常見的導致男性不育的主要原因之一。臨牀上常用精漿中性α-糖苷酶的檢測來判斷男性附睾的功能。
該兩項產品的開發、上市,將進一步豐富公司在男性不育檢測領域的產品線,提升公司診斷試劑產品的市場競爭力,對公司未來的經營將產生積極影響。
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