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干式生化分析方法的建立及其方法學(xué)評(píng)價(jià)

發(fā)布時(shí)間:2018-10-22 15:03
【摘要】:在臨床檢驗(yàn)中,干化學(xué)法與傳統(tǒng)的濕化學(xué)相比具有操作簡(jiǎn)單、檢測(cè)速度快、不需使用液體試劑等優(yōu)點(diǎn)。但是國(guó)內(nèi)干化學(xué)研究起步較晚,大多應(yīng)用國(guó)外成熟技術(shù),因此開發(fā)具有自主知識(shí)產(chǎn)權(quán)的干化學(xué)試劑對(duì)干化學(xué)分析技術(shù)在國(guó)內(nèi)的推廣和應(yīng)用具有重要意義。 本文研制了一類不同于國(guó)外的生化干片,即通過將生化試劑固定在高分子膜載體上來制備干片,制備的干片包括血紅蛋白干片、白蛋白干片、總蛋白干片。并結(jié)合全光譜干式生化分析儀原理機(jī),建立了測(cè)定血紅蛋白、白蛋白、總蛋白的干式生化分析法,并對(duì)所建立的方法進(jìn)行一系列方法學(xué)評(píng)價(jià),包括線性試驗(yàn)、穩(wěn)定性試驗(yàn)、重復(fù)性試驗(yàn)、方法學(xué)比較。 制備出的三種干片顯色均勻、顯色梯度明顯;所建立的干式生化分析法測(cè)定血紅蛋白、白蛋白、總蛋白的線性范圍分別為10-160g/L.5.87-47.0g/L、18-72g/L;以血紅蛋白干片為例,該種干片在保存于4℃冰箱中時(shí),在30天之內(nèi)的穩(wěn)定性良好;批內(nèi)和批間變異系數(shù)均小于5%,說明本方法的重復(fù)性良好;并且與濕化學(xué)法相比表現(xiàn)出良好的相關(guān)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,

本文編號(hào):2287497

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