干式生化分析方法的建立及其方法学评价
发布时间：2018-10-22 15:03
【摘要】：在临床检验中,干化学法与传统的湿化学相比具有操作简单、检测速度快、不需使用液体试剂等优点。但是国内干化学研究起步较晚,大多应用国外成熟技术,因此开发具有自主知识产权的干化学试剂对干化学分析技术在国内的推广和应用具有重要意义。 本文研制了一类不同于国外的生化干片,即通过将生化试剂固定在高分子膜载体上来制备干片,制备的干片包括血红蛋白干片、白蛋白干片、总蛋白干片。并结合全光谱干式生化分析仪原理机,建立了测定血红蛋白、白蛋白、总蛋白的干式生化分析法,并对所建立的方法进行一系列方法学评价,包括线性试验、稳定性试验、重复性试验、方法学比较。 制备出的三种干片显色均匀、显色梯度明显；所建立的干式生化分析法测定血红蛋白、白蛋白、总蛋白的线性范围分别为10-160g/L.5.87-47.0g/L、18-72g/L；以血红蛋白干片为例,该种干片在保存于4℃冰箱中时,在30天之内的稳定性良好；批内和批间变异系数均小于5%,说明本方法的重复性良好；并且与湿化学法相比表现出良好的相关性。
[Abstract]:Compared with traditional wet chemistry, dry chemical method has the advantages of simple operation, high detection speed and no need for liquid reagent. But the domestic dry chemistry research started relatively late, most of the foreign mature technology is applied, so the development of dry chemical reagent with independent intellectual property rights is of great significance to the promotion and application of dry chemical analysis technology in China. In this paper, a kind of biochemical dried tablets, which are different from foreign ones, were prepared by immobilization of biochemical reagents on the polymer membrane carrier to prepare dry slices, including hemoglobin, albumin and total protein. The dry biochemical analysis method for the determination of hemoglobin, albumin and total protein was established by combining with the principle machine of full spectrum dry biochemical analyzer. A series of methods were evaluated, including linear test and stability test. Repeatability test, methodology comparison. The linear range of the established dry biochemical analysis for the determination of hemoglobin, albumin and total protein is 10-160 g / L 5.87-47.0 g / L ~ (18 ~ 72) g / L, respectively. When stored in 4 鈩，
本文编号：2287497
[Abstract]:Compared with traditional wet chemistry, dry chemical method has the advantages of simple operation, high detection speed and no need for liquid reagent. But the domestic dry chemistry research started relatively late, most of the foreign mature technology is applied, so the development of dry chemical reagent with independent intellectual property rights is of great significance to the promotion and application of dry chemical analysis technology in China. In this paper, a kind of biochemical dried tablets, which are different from foreign ones, were prepared by immobilization of biochemical reagents on the polymer membrane carrier to prepare dry slices, including hemoglobin, albumin and total protein. The dry biochemical analysis method for the determination of hemoglobin, albumin and total protein was established by combining with the principle machine of full spectrum dry biochemical analyzer. A series of methods were evaluated, including linear test and stability test. Repeatability test, methodology comparison. The linear range of the established dry biochemical analysis for the determination of hemoglobin, albumin and total protein is 10-160 g / L 5.87-47.0 g / L ~ (18 ~ 72) g / L, respectively. When stored in 4 鈩，
本文编号：2287497
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