申请人:DxGen Corp.
公开号:EP3726215A1
公开(公告)日:2020-10-21
The present invention relates to silica nanoparticles for biomarker diagnosis and a method of manufacturing the same, and more particularly to silica nanoparticles for biomarker diagnosis capable of measuring glycated proteins such as glycated hemoglobin, glycated albumin, etc. used as diabetes diagnosis markers, and a method of manufacturing the same. According to the present invention, silica nanoparticles for biomarker diagnosis, containing a reactive polymer and a nonreactive polymer immobilized on the surface and a dye immobilized inside, immobilize the dye therein through covalent bonding, whereby the dye is not affected by external environmental factors such as heat, pH, etc., and stability is enhanced even upon long-term storage. Also, since multiple dye molecules are immobilized in a single silica nanoparticle, the amount of light absorbed by a single particle is increased compared to that of a single dye molecule, making it possible to accurately measure the amount of glycated protein with a low detection limit. Moreover, since the nonreactive polymer for increasing dispersion stability and the probe-bound reactive polymer are immobilized on the surface of the silica nanoparticles containing the dye immobilized inside, the influence of various proteins and salts included in a sample is minimized, whereby the silica nanoparticles can be applied to a point-of-care testing system using an actual biological material to thus quickly and accurately measure a biomarker to be detected in a stable manner.
本发明涉及生物标志物诊断用二氧化硅纳米粒子及其制造方法,特别是涉及能够测量作为糖尿病诊断标志物的糖化蛋白质(如糖化血红蛋白、糖化白蛋白等)的生物标志物诊断用二氧化硅纳米粒子及其制造方法。根据本发明,用于生物标记诊断的二氧化硅纳米粒子表面固定有活性聚合物和非活性聚合物,内部固定有染料,通过共价键将染料固定在其中,因此染料不受热量、pH 值等外部环境因素的影响,即使长期储存也能提高稳定性。此外,由于多个染料分子被固定在单个二氧化硅纳米粒子中,因此单个粒子吸收的光量比单个染料分子吸收的光量要多,从而能够以较低的检测限精确测量糖化蛋白质的量。此外,由于用于提高分散稳定性的非反应性聚合物和探针结合的反应性聚合物被固定在内部固定有染料的二氧化硅纳米粒子的表面,因此样品中包含的各种蛋白质和盐类的影响降到了最低,从而使二氧化硅纳米粒子可以应用于使用实际生物材料的护理点检测系统,从而以稳定的方式快速准确地测量待检测的生物标记物。