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First testing kit can distinguishes between coronavirus and flu
Published on: 2021-08-23
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An innovative Shanghai-developed nucleic acid kit which can test for both the coronavirus and influenza has been approved by the national authority.
 

The kit can quickly differentiate between coronavirus infection and flu infection. Both have similar symptoms such as fever, throat pain, coughing and fatigue. Flu infection also can result in shadow or ground glass nodule in the lungs.
 

Developed by Shanghai 3DMed Diagnostics, it is the first such testing kit approved in the nation.
 

In addition to the new kit, the company is developing an instant coronavirus testing kit, which can shorten the testing time from 60 minutes to less than 30 minutes.
 

It is also investigating a new coronavirus testing kit targeting the current hyper-contagious Delta variant as well as other variants like Alpha, Beta, Gamma and Lambda to achieve more effective epidemiological investigation and virus-spreading route identification.
 

两种病毒一次检测分辨清楚!沪研新冠、流感联合检测试剂盒获批上市

新冠病毒和流感病毒如何鉴别?现在,一次实验即可获得两大类传染性病原体检测结果。市科委消息称:上海创新企业研制的沪研新冠、流感联合检测试剂盒已获批上市。
 

据悉,在市科委的支持下,上海思路迪生物医学科技有限公司研发生产的“新型冠状病毒2019-nCoV和甲型乙型流感病毒核酸联合检测试剂盒(荧光PCR法)”(以下简称“联合检测试剂盒”)于近日通过国家药品监督管理局(NMPA)审核,获批上市。这是国内首个基于荧光定量PCR平台的新冠联合甲型乙型流感病毒核酸检测试剂盒。
 

该试剂盒实现了呼吸道感染病例中较为常见病原体流感病毒与新型冠状病毒“单管”合并检测,一次实验即可获得两大类传染性病原体检测结果,且全面覆盖了新冠三基因(ORF1ab/N/E基因),是目前针对新冠病毒检测覆盖基因最全产品之一。
 

中国食品药品检定研究院出具的注册检验报告中显示,思路迪公司的联合检测试剂盒分别针对新冠病毒和不同型别(多种亚型) 流感病毒的检出浓度均优于国家注册检验规定要求。
 

同时,针对包括德尔塔(Delta)在内被WHO列为特别关注的突变株(VOC),通过生信分析和湿实验验证探针对上述突变仍然有效。核酸联合检测试剂盒(荧光PCR法)还可配套使用全自动核酸提取仪及提取试剂,并兼容目前市场主流核酸提取系统。

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