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聖湘生物(688289.SH):相關檢測產品獲得歐盟衞生安全委員會HSC common list白名單註冊
格隆匯 12-22 18:35

格隆匯12月22日丨聖湘生物(688289.SH)公佈,公司的產品新型冠狀病毒(SARS-CoV-2)快速抗原檢測試劑(膠體金法)(英文名稱SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method))在已獲得歐盟CE認證的基礎上,於近日進一步獲得歐盟衞生安全委員會HSC common list 白名單註冊,可在歐盟國家和認可歐盟CE認證的國家銷售。

除公司產品獲得歐盟衞生安全委員會(Health Security Committee)HSC common list白名單註冊外,亦有其他公司的相關產品供應市場,且針對新冠肺炎的檢測存在多種方法,故公司產品或將面臨同類產品或其他檢測類產品的市場競爭風險。

本次公司獲得歐盟衞生安全委員會HSC common list白名單註冊的新型冠狀病毒(SARS-CoV-2)快速抗原檢測試劑(膠體金法)採用膠體金免疫層析技術,運用雙抗體夾心法定性檢測人前鼻或鼻咽拭子中的新型冠狀病毒抗原。可在較短時間內完成檢測,操作簡便,無需設備,並肉眼完成結果判讀,在急性感染期病毒載量較高時能夠快速檢出陽性病例,適用於對疑似人羣進行早期分流和快速管理。

公司該產品在已獲得歐盟CE認證的基礎上,進一步獲得歐盟衞生安全委員會HSCcommon list白名單註冊,可在歐盟國家和認可歐盟CE認證的國家銷售。

該認證由歐盟衞生安全委員會在取得歐盟CE認證的產品中,進一步篩選出靈敏度和特異性等滿足更高性能要求的產品,標誌着公司檢測產品從臨牀數據到技術文檔都充分受到歐盟衞生安全委員會的認可,有利於進一步提升公司新冠檢測產品的綜合競爭力,提升公司產品認可度和品牌美譽度,對公司銷售及國際業務拓展具有積極的作用。

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