三种生化试剂干片的制备及检验方法的建立

Development of a dry biochemistry method for the measurement of blood hemoglobin,albumin and total protein in clinical laboratory

目的建立一种简便、快速测定血液中血红蛋白（Hb）、白蛋白（Alb）、总蛋白（Tp）含量的干式生化分析方法。方法筛选出合适的高分子膜材料作为载体,通过将生化试剂固定在载体上来制作干片,利用仪器建立测定血液中Hb、Alb、Tp含量的标准曲线,最后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。结果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Hb、Alb、Tp的线性范围分别为10-160g/L、2.94-47.00g/L、4.5-72g/L;以Hb干片为例,该干片在保存于4℃冰箱中,在30d内的稳定性良好;批内和批间变异系数均〈5%,说明本方法的重复性良好;本方法与湿化学法相比表现出良好的相关性,相关系数〉0.995。结论本研究研制的三种试剂干片,建立了一种简便、快速检测血液中Hb、Alb、Tp的干式生化检验方法,为干化学产品的国产化提供方法学和试验技术基础。

Objective To develop a dry biochemistry testing for simple and rapid measurement of blood hemoglobin,albumin and total protein. Methods Biochemical dry slides were made by fixing the biochemical reagents to a suitable carrier which was screened out from some polymer films.Standard curves for the quantification of hemoglobin,albumin and total protein were established using the dry slides and an instrument.A series of methodological evaluation were performed including linearity test,stability test,repeatability test. Results All three dry slides showed uniform colors with obvious color gradients.The linear ranges of dry biochemistry method were 10-160g/L for hemoglobin,2.94-47.00g/L for albumin and 4.5-72g/L for total protein.Hemoglobin dry slide showed excellent stability within 30 days when stored at 4 ℃ refrigerator.This method also had a good repeatability as the inter-assay and intra-assay coefficient of variation were all less than5%.The correlation between dry chemistry method established and wet chemistry method proved to be good as their correlation coefficients were all more than 0.995. Conclusions A simple and rapid dry biochemistry method for the test of blood hemoglobin,albumin and total protein is developed and proved to be stable and repeatable,which provides methodological and technical basis for localization of dry chemical products.