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乐普医疗(300003.SZ):新冠抗原(SARS-COV-2)检测试剂盒(胶体金免疫层析法)入围出口“白名单”
格隆汇 11-09 16:10

格隆汇 11 月 9日丨乐普医疗(300003.SZ)公布,公司旗下子公司北京乐普诊断科技股份有限公司(“乐普诊断”)始终致力于IVD域产品的研发与制造日获悉,自主研发的抗原检测试剂盒入围出口“白名单”,这是继20203月自主研发的新型冠状病毒(SARS-CoVer-2)抗体检测试剂盒后再一次取得欧盟市场市场准入资格

抗原检测试剂盒不同于抗体检测试剂盒,而是用于定性快速检测临床样本(鼻拭子)中的新冠状病毒(SARS-CoV-2)抗原,采用特异性的抗体抗原反应及免疫分析技术,检测盒含有预先包被在结合垫上的金标新型冠状病毒N蛋白单克隆抗体以及固定于测试区(T)的配对新型冠状病毒N蛋白单克隆抗体和质控区(C)的相应抗体,以达到对新型冠状病毒感快速更精准检测。同时,新冠抗原(SARS-COV-2)检测试剂盒已经通过巴基斯坦伊斯兰堡诊断中心临床验证,诊断灵敏度为97.47%,诊断特异性为95%,测试结果表现良好。

“白名单”的入围将为全球新冠肺炎的疑似患者、隔离或医学观察和其他需要进行新型冠状病毒感染诊断或鉴别诊断者提供更加快速、准确、便捷的现场检测手段。乐普诊断将加大生产力度,积极保障产品的安全性和有效性,为抗击全球新冠疫情反复积极做好准备,为人类健康事业做出贡献。

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