胃癌标志物磁层析检测数据集

与企业合作，开发了幽门螺旋杆菌分型检测芯片（检测血液中CagA, VacA, Ure IgG抗体），获得医疗器械注册证，国械注准20213400830，研发了蛋白芯片阅读仪，获得医疗器械注册证，苏械注准20182220049。
建立了高温热分解法制备磁性纳米粒子的工艺流程，建立了抗体偶联磁性纳米粒子工艺流程，建立了磁性纳米粒子的表征方法，偶联抗体后生物活性评价标准的建立。制备的磁性纳米粒子获得第三方CNNS报告(报告编号NERCN-22-18187)。与苏州康立达纳米生物医学工程有限公司合作，研发了磁定量免疫层析分析仪，通过第三方注册检，磁定量免疫层析分析仪标准卡标定通过注册检。开发了系列磁性纳米粒子标记的胃癌血清中蛋白标志物检测的磁层析芯片，在申报注册证。在数据信号处理方面，采用了机器学习的方法，针对低浓度芯片的信号实现了准确的分类处理，大大提高了弱信号芯片的检出率和准确性。与南京中科拜尔医学科技有限公司合作，研发的基于磁性纳米粒子的核酸提取纯化试剂盒，获得医疗器械注册证书；研发的全自动核酸提取纯化仪获得医疗器械注册证书。与江苏吉诺思美精准医学科技有限公司合作，研发了新一代的基于磁性纳米粒子的核酸提取纯化试剂盒与全自动核酸提取纯化仪，获得医疗器械证书（苏宁械备20200122；苏宁械备20200121；苏宁械备20200199）。研发的胃蛋白酶原Ⅰ/胃蛋白酶原Ⅱ检测试剂盒, 获医疗器械注册证：苏械注准字20202400768。胃泌素-17 检测试剂盒，获医疗器械注册证, 苏械注准字20212401412。

In collaboration with enterprises, we developed a Helicobacter pylori genotyping detection chip (detects CagA, VacA, Ure IgG antibodies in blood) and obtained the national medical device registration approval No. 20213400830; we also developed a protein chip reader, which obtained the Jiangsu Provincial Medical Device Registration Approval No. 20182220049. We established the technical process for preparing magnetic nanoparticles via high-temperature thermal decomposition method, the process for coupling antibodies to magnetic nanoparticles, the characterization method for magnetic nanoparticles, and the biological activity evaluation standard after antibody coupling. The prepared magnetic nanoparticles obtained a third-party CNNS test report with the serial number NERCN-22-18187. In collaboration with Suzhou Kanglida Nano Biomedical Engineering Co., Ltd., we developed a magnetic quantitative immunochromatography analyzer, which passed the third-party registration inspection, and the standard card calibration of this analyzer also passed the registration inspection. We developed a series of magnetic chromatography chips for detecting protein markers in gastric cancer serum labeled with magnetic nanoparticles, which are currently under registration certificate application. For data signal processing, machine learning methods were adopted to achieve accurate classification and processing of signals from low-concentration chips, greatly improving the detection rate and accuracy of weak-signal chips. In collaboration with Nanjing Zhongke Baier Medical Technology Co., Ltd., the developed magnetic nanoparticle-based nucleic acid extraction and purification kit obtained the medical device registration certificate, and the fully automatic nucleic acid extraction and purification instrument also obtained the corresponding medical device registration certificate. In collaboration with Jiangsu Jinuosmei Precision Medicine Technology Co., Ltd., we developed a new generation of magnetic nanoparticle-based nucleic acid extraction and purification kits and fully automatic nucleic acid extraction and purification instruments, which obtained medical device registration certificates with the filing numbers Su Ning Xie Bei 20200122, Su Ning Xie Bei 20200121, and Su Ning Xie Bei 20200199. The developed pepsinogen I/pepsinogen II detection kit obtained the medical device registration certificate: Jiangsu Provincial Medical Device Registration Approval No. 20202400768. The gastrin-17 detection kit also obtained the medical device registration certificate: Jiangsu Provincial Medical Device Registration Approval No. 20212401412.

搜集汇总

背景与挑战

背景概述

该数据集聚焦于胃癌标志物的磁层析检测技术，涉及磁性纳米粒子的制备、抗体偶联工艺及基于机器学习的数据信号处理方法的开发。相关成果已转化为多项获得医疗器械注册证的检测芯片、试剂盒及分析仪器。