聖湘生物(688289.SH):相關新冠檢測產品獲得歐盟CE認證及奧地利白名單註冊
格隆匯5月24日丨聖湘生物(688289.SH)公佈,公司的產品新型冠狀病毒(SARS-CoV-2)5種突變核酸檢測試劑盒(熒光PCR法)(英文名稱Detection Kit for 5 Mutations of SARS-CoV-2(PCR-Fluorescence Probing))於近日獲得歐盟CE認證,新型冠狀病毒(SARS-CoV-2)快速抗原檢測試劑(膠體金法)自測產品(英文名稱SARS-Cov-2 Rapid Antigen Test(Colloidal Gold Method)(nasal)Self-test)獲得奧地利聯邦衞生保健安全辦公室(Austrian Federal Office for Safety in Health Care)批准,進入白名單。
該產品通過多重熒光PCR方法,一次測試可同步完成對新冠病毒5種突變(N501Y、HV69-70del、K417N、P681H和E484K)的快速鑑別檢測,實現變異型病毒株(B.1.1.7、B.1.351、P.1)的快速鑑別診斷。同時,該產品採用新冠保守序列N基因作為監控內標,有效地提升了樣本檢測結果的準確性,將有助於新冠病毒變異株的快速鑑定和監測。
新冠快速抗原檢測試劑自測產品,可由個人自行採集鼻拭子進行操作,方便個人及家庭進行新冠病毒的快速檢測,進一步豐富了聖湘生物全場景化新冠檢測解決方案。
公司以上產品獲得歐盟CE認證後,可在歐盟國家和認可歐盟CE認證的國家銷售,獲得奧地利白名單註冊後,可在奧地利進行銷售。上述產品可滿足臨牀使用需求,由此,公司海外銷售產品品類得到進一步擴充,對公司銷售及國際業務拓展具有積極的作用。
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