新冠抗原快速检测试剂 (SARS-CoV-2) Antigen.pptx

Novel Coronavirus(SARS-CoV-2)Antigen Rapid Detection Kit江西省金洹医疗器械股份有限公司Jiangxi Province JinHuan Medical Instrument Co.,Ltd.新型冠状病毒新型冠状病毒(SARS-CoV-2)抗原快速检测试剂盒抗原快速检测试剂盒(胶体胶体金法金法)目录公司简介 Company ProfileA产品介绍 Product DescriptionB公司资质 Company QualificationC公司简介 Introduction 江西省金洹医疗器械股份有限公司成立于2011年，坐落于江西省南昌经济技术开发区，占地40亩，3栋自主产权大楼，建筑面积3.5万平米。金洹医疗是一家集研发、生产、销售自动化检验设备、体外诊断试剂、互联网无创家用检测平台、消毒用品、防护用品等高新技术企业。设有自己的研发中心，拥有一流的自动化研发团队和自主知识产权。现已成为中国领先的粪便自动化检验仪供应商，并打造中国互联网无创家用检测专业平台。自动化检验设备改变了现有手工检测粪便和白带的模式；互联网家用检测产品是通过手机APP+试纸的方式，实现了随时随地做检测的创新，颠覆了现有只能在医疗机构做检测的模式。打造中国互联网无创家用检测专业平台！国家高新技术企业 /院士工作站 /I、II、II类医疗器械生产、经营许可企业通过ISO13485质量管理体系 /通过CE认证 /进出口业务 /校企合作科技部科技型中小企业技术创新基金项目承担单位 新冠抗原检测试剂盒实物图20人份独立包装MAIN COMPONENTSMaterials delivered（Anterior nasal swab）Number of products(1 Test/Kit)Number of products(20 Tests/Kit)Test suite1 test20 testsswab stick1 piece20 pcsExtraction solution1 bottle20 bottlesinstructions1 piece1 pieceMaterials delivered（Posterior oropharyngeal saliva：）Number of products(1 Test/Kit)Number of products(20 Tests/Kit)Test suite1 test20 testsDisposable dropper1 piece20 pcsExtraction solution1 bottle20 bottlesinstructions1 piece1 piece新型冠状病毒(SARS-CoV-2)抗原快速检测试剂盒规格及货运箱规规格Specifications每箱装运数量Kitquantity per carton中包装盒尺寸Box size整箱尺寸FCL size单盒试剂毛重（Kg）Gross weight of single box reagent(Kg)整箱毛重（Kg）Gross weight of the whole box(Kg)20人份/盒20 Tests/Kit800人份800 Tests20.513.56.8cm564338 cm0.28kg12.8kg1人份/盒1 Tests/Kit20人份/盒20 Tests/Kit800人份800 Tests19.21413cm6757.540.5cm0.55kg23.5kg注：外贸报关运输的尺寸重量，以实物为准！新型冠状病毒(SARS-CoV-2)抗原快速快速检测试剂盒货运箱规：Novel Coronavirus(SARS-CoV-2)Antigen Rapid Detection Kit Freight container regulations新型冠状病毒(SARS-CoV-2)抗原快速检测试剂盒规格信息：Novel Coronavirus(SARS-CoV-2)Antigen Rapid Detection Kit specification information产品名称Product name规格Specifications单位Unit新型冠状病毒(SARS-CoV-2)抗原快速检测试剂盒Novel Coronavirus(SARS-CoV-2)Antigen Rapid Detection Kit1人份/盒1 Tests/Kit20人份/盒20 Tests/Kit盒/kit储存条件：4-30避光干燥阴凉处储存。Store as packaged in the sealed pouch at temperature(4-30).有效期：18个月 Validity period:18 months产品特点 Features of the productFeatures of the productu High-quality monoclonal paired antibodies with high affinity,using double antibody sandwich method.优质亲和力高的单克隆配对抗体，运用双抗体夹心法.u High total coincidence rate,not affected by virus mutation,no cross-reaction with common respiratory viruses.高总符合率，不受病毒变异影响，与常见呼吸道病毒无交叉反应.u Non-invasive sampling,sample type:oropharyngeal swab,sputum(saliva),testing anytime,anywhere.无创取样，样本类型：口咽部拭子、痰（唾）液、随时随地检测；u Storage temperature:4-30,convenient for transportation at room temperature.储存温度:4-30,方便常温运输；u Detection time 15-20 minutes.检测时间1520分钟；u Convenient operation,no equipment,no cold chain transportation.操作便捷，无需仪器，无需冷链运输；u Can be used for home testing,testing at designated institutions(such as hospitals),screening before the resumption of work or school.可用于居家检测，定点机构（如医院）检测，企业复工或学校复课前的筛查。2.咽后唾液取样步骤：Sampling procedure of saliva after swallowing:1.Perform hand hygiene with soap and water/alcohol-based hand rub.用肥皂和水/酒精为基础的手擦进行手卫生。2.Open the container.Make a“Kruuua”noise from the throat to clear the saliva from deep throat，then spit saliva(about 2 ml)into the container.Avoid any saliv contamination of the outer surface of the container.打开容器，从喉咙发出“克鲁瓦”的声音从喉咙深处来清除唾液，然后将唾液（约2毫升）吐入容器。避免容器外表面的任何唾液污染。3.Optimal timing of specimen collection：After getting up and before brushing teeth,eating or drinking.标本采集的最佳时机：起床后和刷牙、进食前。咽后唾液检测步骤咽后唾液检测步骤Posterior oropharyngeal saliva:Posterior oropharyngeal saliva:1.Take an extraction tube from the kit and remove a test cassette from the foil pouch by tearing at the notch.Place them on a level surface.2.Add 10 drops(or 450500 L)of sample lysis solution into the Extraction tube.3.Take 200 L300 L of fresh saliva samples with a disposable dropper from container.4.Transfer the saliva samples into the Extraction Tube and shake and mix5.Firmly attach Dropper Lid to the top of the Extraction tube.Then gently invert the Extraction tube 5 times.6.Transfer 23 drops(about 100L)specimen to the sample area of the Test Strip.Note:If using a frozen sample,the sample must be at room temperature before testing.7.Read the results in 15-20 minutes.Do not interpret the result exceed 20 minutes.新冠抗原试剂使用说明书-中文版新冠抗原试剂使用说明书-中文版新冠抗原试剂使用说明书-中文版新冠抗原试剂使用说明书-中文版新冠抗原试剂使用说明书-中文版新冠抗原试剂使用说明书-英文版新冠抗原试剂使用说明书-英文版新冠抗原试剂使用说明书-德文版新冠抗原试剂使用说明书-德文版BFArM 白名单仅供外贸使用仅供外贸使用仅供外贸使用金洹医疗防疫物资全部进入了商务部出口白名单企企企企 业业 荣荣荣荣 誉誉誉誉