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新產業(300832.SZ):公司新型冠狀病毒檢測產品取得CE准入資格
格隆匯 09-10 20:42

格隆匯9月10日丨新產業(300832.SZ)公佈,近日,公司收到了SARS-CoV-2 Antigen Rapid Test(ColloidalGold)、SARS-CoV-2RT-PCR Assay兩項產品的德國註冊提交憑證。

國際臨牀化學協會在關於新冠抗原POCT檢測的指南中指出:儘管核酸擴增檢測(NAAT)仍然是檢測和理論上量化各種樣本中SARS-CoV-2mRNA的金標準,但在特定情況下,抗原檢測可能被認為是一種合適的替代方法。快速抗原測試旨在檢測生物標本(例如鼻、鼻咽、唾液)中的病毒抗原蛋白,以指示當前的SARS-CoV-2感染。

此次獲證的新型冠狀病毒(2019-nCoV)抗原檢測試劑盒(膠體金法)應用了SARS-CoV-2特異性抗體直接檢測經口咽、鼻咽拭子取樣樣本中新冠病毒核衣殼蛋白,通過膠體金標記物進行分析,從而對病毒病原體進行判斷。該試劑盒具有操作簡便、報吿時間短等優勢,可用於對新冠疑似人羣進行早期分流和快速管理。

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