通過快速批准流程,獲得了來自四家公司的四種新穎冠狀病毒測試產品

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.中國國家藥品監督管理局於XNUMX月XNUMX日晚宣布,已通過快速批准程序批准了四家公司的四款新型冠狀病毒檢測產品。 It will further expand the supply capacity of Novel Coronavirus nucleic acid detection reagents to fully serve the epidemic prevention and control needs.它將進一步擴大新型冠狀病毒核酸檢測試劑的供應能力,從而完全滿足防疫工作的需要。
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,已經緊急批准了包括新冠狀病毒XNUMX-ncov核酸檢測試劑盒(熒光PCR方法)和XNUMX新型冠狀病毒核酸測序系統在內的四種產品。 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.同時,還要求省藥品監督管理部門加強對上述產品生產廠家的監督檢查,以確保產品質量和安全。
In accordance with the conventional procedures, it takes 2-3 years of clinical trials before in vitro molecular diagnostic products into the hospital market.按照常規程序,體外分子診斷產品進入醫院市場需要XNUMX-XNUMX年的臨床試驗。 This time, the national medical products administration opened a green channel that only four days have gone through the process.這次,國家醫療產品管理局開闢了一條綠色通道,整個過程僅進行了四天。
國家藥品監督管理局將繼續對預防和控制流行病所需的藥品和醫療器械採取特殊的批准程序,並努力使相關產品盡快上市。
(以下簡稱枝江生物),國家醫藥集團中國上海洁氏生物技術有限公司。 (以下簡稱網關),基因組技術(深圳)有限公司。 (以下簡稱“基因組學”),深圳智能科技有限公司。 (以下簡稱華達智能),後兩者均為華達。
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.據枝江介紹,新開發的試劑盒採用多重熒光PCR技術,通過單管雙重測試可同時確定新冠狀病毒的兩個獨立基因,從而消除了因病毒變異而導致漏檢的風險。 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.同時,可以排除SARSXNUMX菌株和batsars樣菌株的非特異性干擾,並且可以精確靶向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.新試劑盒的開發是對原始冠狀病毒核酸檢測試劑盒產品類別的補充。
該試劑盒用於定性檢測咽拭子,痰液和肺泡灌洗液中需要診斷或鑑別診斷為新型肺炎病毒感染的體外診斷的咽拭子樣本中的新型冠狀病毒(2019-ncov)ORF1ab,N基因和E基因,疑似集群病例和其他新的冠狀病毒感染患者。
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.疫情爆發後,國家有關部門加大了對新型冠狀病毒性肺炎治療藥物和檢測試劑的監督管理。 Chinese biology responded immediately and set up a leading group for the emergency prevention and control of novel coronavirus.中國生物學立即作出反應,並成立了應急預防和控制新型冠狀病毒的領導小組。 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.上海芝諾的醫學診斷部門立即進行研發,經過設計,優化和測試,首次成功開發出新型冠狀病毒核酸分子檢測試劑盒,並首次送往中國疾病預防控制中心。 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已成為用於多區域疾病控制的新型冠狀病毒肺炎病毒核酸檢測試劑盒的供應商。
除以上公司外,聖祥生物,飛瑞生物,柏格醫療,大安基因四家企業也進入了國家食品藥品監督管理局的快速批准,有望在不久的將來獲得正式批准。