通过快速批准流程,获得了来自四家公司的四种新颖的冠状病毒测试产品

China's national medical products administration announced late on January 26 that it had approved four Novel Coronavirus testing products from four companies through a fast-track approval process.中国国家药品监督管理局于XNUMX月XNUMX日晚宣布,已通过快速批准程序批准了四家公司的四款新型冠状病毒检测产品。 It will further expand the supply capacity of Novel Coronavirus nucleic acid detection reagents to fully serve the epidemic prevention and control needs.它将进一步扩大新型冠状病毒核酸检测试剂的供应能力,以充分满足防疫工作的需要。
Currently, four products, including Novel Coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method) and the 2019 novel coronavirus nucleic acid sequencing system, have been approved on an emergency basis.目前,已紧急批准了包括Novel Coronavirus XNUMX-ncov核酸检测试剂盒(荧光PCR法)和XNUMX Novel Coronavirus核酸测序系统在内的四种产品。 At the same time, provincial drug supervision departments have been required to strengthen the supervision and inspection of the above-mentioned product manufacturers to ensure product quality and safety.同时,还要求省药品监督管理部门加强对上述产品生产企业的监督检查,以确保产品质量和安全。
In accordance with the conventional procedures, it takes 2-3 years of clinical trials before in vitro molecular diagnostic products into the hospital market.按照常规程序,体外分子诊断产品进入医院市场需要XNUMX-XNUMX年的临床试验。 This time, the national medical products administration opened a green channel that only four days have gone through the process.这次,国家医疗产品管理局开辟了一条绿色通道,整个过程仅进行了四天。
国家药品监督管理局将继续对预防和控制流行病所需的药品和医疗器械采取特殊的批准程序,并努力使相关产品尽快上市。
(以下简称枝江生物),国家医药集团中国上海洁氏生物技术有限公司。 (以下简称网关),基因组技术(深圳)有限公司。 (以下简称“基因组学”),深圳智能科技有限公司。 (以下简称华达智能),后两者均为华达。
According to zhijiang, the newly developed kit USES multiple fluorescence PCR technology to simultaneously determine two independent genes of the new coronavirus by single tube double test, eliminating the risk of missed detection caused by virus variation.据枝江介绍,新开发的试剂盒采用多重荧光PCR技术,可通过单管双重测试同时确定新冠状病毒的两个独立基因,从而消除了因病毒变异而导致漏检的风险。 At the same time, the non-specific interference of SARS2003 strain and batsars-like strain can be excluded, and the 2019-ncov virus can be precisely targeted.同时,可以排除SARSXNUMX菌株和batsars样菌株的非特异性干扰,并且可以精确靶向XNUMX-ncov病毒。 The development of the new kit is a supplement to the product categories of its original coronavirus nucleic acid detection kit.新试剂盒的开发是对原始冠状病毒核酸检测试剂盒产品类别的补充。
该试剂盒用于定性检测咽拭子,痰液和肺泡灌洗液的体外样本中新型冠状病毒(2019-ncov)的ORF1ab,N基因和E基因,在疑似肺炎病例中需要诊断或鉴别诊断为新型冠状病毒感染,疑似集群病例和其他新的冠状病毒感染患者。
After the outbreak of the epidemic, the relevant departments of the state intensified the supervision and control of novel coronavirus pneumonia treatment drugs and detection reagents.疫情暴发后,国家有关部门加大了对新型冠状病毒性肺炎治疗药物和检测试剂的监督管理。 Chinese biology responded immediately and set up a leading group for the emergency prevention and control of novel coronavirus.中国生物学立即作出反应,并成立了应急预防和控制新型冠状病毒的领导小组。 The medical diagnosis sector of Shanghai zeno immediately put into research and development, after design, optimization and test, the first successful development of novel coronavirus nucleic acid molecular detection kit, and the first time sent to the Chinese center for disease control and prevention verification.上海芝诺的医学诊断部门立即进行研发,经过设​​计,优化和测试,首次成功开发出新型冠状病毒核酸分子检测试剂盒,并首次送往中国疾病预防控制中心。 Therefore, zhongshengzenuo has become the supplier of novel coronavirus pneumonia virus nucleic acid detection kit for multi-area disease control.因此,中生zenuo已成为用于多区域疾病控制的新型冠状病毒肺炎病毒核酸检测试剂盒的供应商。
除以上公司外,盛祥生物,飞瑞生物,柏格医疗,大安基因四家企业还进入了国家食品药品监督管理局的快速批准,有望在不久的将来获得正式批准。