中国研发的新型冠状病毒核酸检测试剂盒,已于28日通过中国国家药品监督管理局审批,获得医疗器械注册证书。
这个新测试剂盒宣称可在30分钟内获得结果,大幅缩短检测时间,可以让疫情疑似病例,尤其是没有病症的隐性感染者得到快速分流,有效防止疫情扩散。
这项产品由中国圣湘生物科技公司推出,中国体外检测诊断领域专家戴立忠主导的应急技术攻关小组研发,采用“RNA一步法”技术,适用于不同场景,操作简单,检测耗时短,再搭配圣湘生物自主研发的全自动核酸提取仪、移动分子诊断平台,能实现1人1机1日检测样本量达1000人份以上的高通量检测,最快可在30分钟出检测结果,实现现场即时检测。
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