新產業(300832.SZ):乙型肝炎e抗體(Anti-HBe)產品取得註冊證
格隆匯5月12日丨新產業(300832.SZ)公佈,近日,公司收到了國家藥品監督管理局頒發的1項《醫療器械註冊證》,產品名稱為乙型肝炎病毒e抗體測定試劑盒(化學發光免疫分析法)。
此次乙型肝炎e抗體(Anti-HBe)產品取得註冊證,補全了公司傳染病項目中的乙肝五項定量檢測試劑菜單。乙肝表面抗原(HBsAg)、乙肝表面抗體(Anti-HBs)、乙肝e抗原(HBeAg)、乙肝e抗體(Anti-HBe)和乙肝核心抗體(Anti-HBc)稱為乙肝五項,是常用的HBV感染的檢測指標,可反映被檢者體內HBV水平、HBV活躍程度以及機體的反應情況。乙肝五項檢測分為定性和定量兩種,定性檢查只能提供陰性或陽性結果,定量檢查則可提供各項指標的精確數值,對乙肝的篩查與預防,乙肝患者的病情監測、治療評估和預後判斷等方面有更重要的意義,動態監測可作為臨牀醫師制定治療方案的依據。
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