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聖湘生物(688289.SH):相關產品取得醫療器械註冊證
格隆匯 06-06 19:23

格隆匯6月6日丨聖湘生物(688289.SH)公佈,產品乙型肝炎病毒核糖核酸(HBVRNA)定量檢測試劑盒(PCR-熒光探針法)於近日收到由國家藥品監督管理局頒發的《醫療器械註冊證》。乙型肝炎病毒核糖核酸(HBVRNA)定量檢測試劑盒(PCR-熒光探針法)是公司在病毒性肝炎篩查及診斷領域取得醫療器械註冊證的第八款試劑盒,該試劑盒檢測靈敏度達50copies/mL,線性範圍達1.0E+02copies/mL~1.0E+09copies/mL,可用於定量檢測臨牀血清樣本中的乙型肝炎病毒(HBV)RNA,檢測結果可作為乙型肝炎感染者臨牀診療的重要輔助指標之一,並可更加直觀的反映cccDNA的轉錄活性,預測治療應答和停藥風險,輔助血清學轉換評估,幫助臨牀醫生更準確地評估患者的治療進展和預後情況,為個體化治療方案的制定提供科學依據。

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