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新產業(300832.SZ):兩項新冠毒檢測產品取得CE准入資格
格隆匯 12-28 11:58

格隆匯12月28日丨新產業(300832.SZ)宣佈,近日,公司收到了SARS-CoV-2 & Flu A/B RT-PCR Assay及SARS-CoV-2 Neutralizing Antibody(CLIA)的德國註冊提交憑證。

其中,SARS-CoV-2 & Flu A/BRT-PCR Assay用於從疑似呼吸道感染個體的口咽拭子、鼻咽拭子及鼻咽/鼻腔沖洗液中定性檢測和鑑別SARS-CoV-2、甲型流感、乙型流感病毒RNA。該項試劑被用於SARS-CoV-2、甲型流感和乙型流感差異檢測,但不用於檢測丙型流感。

SARS-CoV-2 NeutralizingAntibody (CLIA)是一種通過MAGLUMI系列全自動化學發光免疫分析儀,定量測定人血清和血漿中對SARS-CoV-2 中和 抗體 的體外化學發光免疫分析試劑,該試劑被用於識別對SARS-CoV-2 有適 應性 免疫反應的個體,以表明其近期或早期被感染過。該試劑盒不應用於診斷急性SARS-CoV-2感染。

公司表示,上述兩項產品已完成歐盟准入的所有流程,能夠加貼CE標誌進入歐盟市場,將進一步豐富公司新冠病毒檢測產品類型,增強公司新冠病毒檢測產品的綜合競爭力,滿足多種應用場景的臨牀需求。

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