Nano Labeled Rapid Immunoassay Test Paper Card for COVID-19 Antigen and Antibody
admin
2022-09-16
新冠抗原抗体的纳米标记免疫快检试纸卡
Nano Labeled Rapid Immunoassay Test Paper Card for COVID-19 Antigen and Antibody
技术编号
HUB-054
提供单位
华中科技大学
技术大类
其他技术
联系人
杨祥良
技术类型
其他技术
电话
13807172067
邮箱
yangxl@hust.edu.cn
适用范围
生物医药,体外诊断试剂
推荐单位
湖北省科技厅
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Technical principle and process routeBased on nano-labeling technology (colloidal gold, rare earth fluorescent nanoparticles, supermagnetic microspheres), a series of rapid detection methods and products for new coronavirus antigen and antibody based on immunochromatography have been developed, realize antibody detection in human serum, COVID-19 antigen (protein) detection in human samples and environmental samples. It can be interpreted by the naked eye or an optical detector, and the test result can be obtained in about 10 minutes. It is suitable for on-site rapid screening of COVID-19 in non-laboratory environments.
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技术提供方华中科技大学,武汉纳达康生物科技有限公司
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技术主要指标信息体积不超过20cm x 10cm x 5cm;重量≤500 g;常温稳定18个月。
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商业应用情况0
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希望在技术转移过程中得到的帮助/支持
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商业应用单位联系人/电话/邮箱
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设备投资根据生产规模,需要数百至数千平米的十万级洁净车间(含空气过滤净化系统)。组装车间要求湿度<30%,需要有相应的空气除湿设备。 试剂盒生产所需半成品(大板)可由国内生产后发往国外组装。组装工作所需设备简单,可手工操作。无其他大型生产设备需求。 按1000平米生产车间面积估算(不含仓库及办公区),车间改造及设备投资约500万元人民币
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年运行维护费用系统正常运行时主要费用是十万级洁净车间的空气过滤净化系统和空气除湿设备所产生电费、维修费等。半成品大板可由国内提供。 组装工人无特殊技能要求,熟练工人每人每天可生产1000~3000条。 按1000平米生产车间面积估算,每年运行维护费用约30万元(不含场地租金)。
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投资回收期该项投资资金需要500万元左右,根据目前国外市场调研情况,新冠抗原检测目前需求非常旺盛,仅德国一个州的采购需求量就在1000万人份,而且在目前新冠疫苗开始注射的背景下,新冠抗原检测也是将来市场所急需的产品,目前江浙区域的新冠抗原抗体公司年收入都在1亿元以上,我们根据实际情况预计该项目两年内销售预测可达5000万元,在目前行业平均净利润率在15%的背景下,该项目可以在两年内收回投资。
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附加效益我们比较同类技术增加了流感抗原的检测,并在检测卡中增加了水溶微球的制备,比较同类产品可以增加额外产值,目前出口的新冠抗原试剂价格在三美元至六美元不等,但是如果增加了流感抗原检测,同等需求下,销售价格可以达到六美元至十二美元,明显获得了额外的经济收益
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综合效益纳米标记检测技术解决了新冠抗原抗体高灵敏快速测量的关键问题。采用稀土荧光纳米粒标记的检测仪,配合荧光检测仪,方法灵敏度比传统胶体金检测卡提高3~5倍。 该试剂成本低廉,非常适合新冠疫情高发区域的现场快筛检测。
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障碍对技术转移影响等级0
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提交日期2020/12/31
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技术成熟度已完成产品研发工作。新冠抗原检测卡和抗体检测卡均已获得欧盟CE认证,并进入商务部出口白名单。
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Technical adaptability analysisThe COVID-19 test meets the needs of the sustainable development of the " the Belt and Road" countries. It is the on-site rapid detection technology required by the current countries, and the comprehensive benefits are obvious. The reagent is low-cost and very suitable for on-site rapid screening in areas with high incidence of the new crown epidemic. The technical intellectual property rights are clear, the technical risks are controllable, and the technical economy is outstanding. Many domestic companies have similar technologies. This product does not require large-scale production equipment, and only requires a minimum of hundreds of square meters of clean workshops and drying workshops (humidity <30%). The technical side can provide semi-finished slabs, which are assembled and sold by local enterprises.
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echnical stability analysisBoth the COVID-19 antigen test card and antibody test card have obtained EU CE certification and entered the export white list of the Ministry of Commerce. The product can be stored at room temperature for more than 18 months.
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Technical safety analysisThis project is an in-vitro diagnostic reagent in medical devices, which conforms to the industrial policies, standards and relevant laws of the "the Belt and Road" countries, and can be quickly implemented and market-oriented in the " the Belt and Road" countries. There is no secondary pollution in the production and assembly process, and no leakage of flammable, explosive, and highly toxic substances. No virus and nucleic acid materials are involved, and there is no biological safety issue.
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技术转移推广障碍0
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知识产权转让该技术由华中科技大学和武汉纳达康生物科技有限公司联合开发。已授权中国发明专利4项,已申请中国实用新型专利3项。 ① 一种免疫层析试纸卡定量检测方法 中国专利 201410314400.X. 2016 2016-03-02授权 ② 一种水溶性微球的制备方法及其应用 中国专利 201610416623.6. 2018 2018-06-26授权. ③ 一种免疫层析试纸卡的快速检测方法 中国专利 201710488721.5. 2019 2019-06-28授权. ④ 一种免疫层析试纸卡的快速定量检测方法. 中国专利 201810145287.5. 2020 2020-04-21授权. ⑤ 一种新型冠状病毒抗体胶体金免疫层析检测卡及检测方法 中国专利 202010866742.8.已申请 ⑥ 一种新型冠状病毒抗体检测试纸条及其应用 中国专利 202010866730.5. 已申请 ⑦ 一种新型冠状病毒抗体磁免疫化学发光检测试剂盒及应用 中国专利 202010889966.0. 已申请 本技术所有权主体清晰无知识产权纠纷。华中科技大学为相关专利的第一专利权所有人。所有专利权人有转让意愿将该技术授