融中财经:经多中心临床验证,金准生物新冠肺炎检测试剂研制成功

来源:融资中国      日期:02-14 15:26     浏览数:6251次
融中财经:经多中心临床验证,金准生物新冠肺炎检测试剂研制成功

由于缺乏快速、便捷、灵敏的技术,新型冠状病毒感染的筛查试剂盒仍极为缺乏。抗体检测是病毒感染的重要诊断方法,在现有免疫学检测方法中,免疫层析具有快捷、操作简单、常温保存、无需冷链运输及无需大型检测仪器的独特优势,是现场快速筛查的最理想手段。

针对现有免疫层析方法灵敏度较低,易导致低浓度抗体的漏检的不足,深圳市金准生物医学工程有限公司联合南开大学丁丹教授团队、南方医科大学南方医院郑磊教授团队、华南理工大学唐本忠院士团队夜以继日开展联合攻关,近日成功研制出新冠病毒IgM/IgG抗体快速检测试剂盒(AIE DOTS/量子点免疫荧光层析法)。该检测试剂盒具备测试快速(15分钟)、操作简便、容易判读等优势。同时,配套检测设备小巧,可放入生物安全柜操作,适用场景广,可降低操作人员感染风险。

本次试剂盒由多家临床单位进行验证,初步的临床试验结果显示,团队定型的工艺路线一检测卡在40例确诊新冠患者血液中成功检出抗体阳性30例(75%),其中IgM阳性16例(40%),IgG阳性28例(70%),在健康对照及非新冠疾病中均未检出,达到预期效果。团队定型的工艺路线二检测卡经过75例临床结果显示符合率较低,宣告失败。工艺路线一方法有望突破现有核酸检测方法对人员、场所的限制,缩短检测用时,提升便捷程度,推动诊断前移下移,实现疑似患者的快速诊断和密切接触人群的现场筛查。

目前第一批生产试剂盒已捐赠至国内多家新冠定点收治医院使用。

深圳市金准生物,在2014年全球首家实现量子点在体外诊断试剂的产业化应用,由深圳市东方融润投资管理有限公司、深圳国中创业投资管理有限公司、安芙兰资本联合投资。

备注:Aggregation-induced emission,聚集诱导发光,简称AIE。

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