建立泸州地区糖化血红蛋白检测结果一致性

发布时间：2018-04-21 00:30

本文选题：糖化血红蛋白 + 一致性　；参考：《四川医科大学》2015年硕士论文

【摘要】：目的:本文旨在调查泸州地区糖化血红蛋白(glycosylated hemoglubin,GHb)相关项目的基本情况,为建立泸州地区糖化血红蛋白检测结果的一致性奠定基础;2015年四川医科大学附属第一医院检验科BIORAD D-10型糖化血红蛋白分析仪为基础,建立泸州县市级医疗机构糖化血红蛋白结果的一致性,实现检测结果的相互认可;通过评价新鲜全血调查品在糖化血红蛋白一致性建立前后的离散度趋势:包括标准差和变异系数。方法:采用问卷调查方式了解泸州县市级七家医院(以A,B,C,D,E,F,G字母代表七家医院名称)糖化血红蛋白分析仪的基本情况;四川医科大学附属第一医院医学检验科糖化血红蛋白仪为参考系统,其他参加实验室作为比对系统,由四川医科大学附属第一医院提供3份赋值新鲜全血校准品,20份比对样本品及5份不同浓度新鲜全血调查品,首先参加实验室测定3份新鲜全血校准品,20份比对样本品及5份不同浓度新鲜全血调查品,其次将各实验室3份新鲜全血校准品测定结果与赋值新鲜全血校准品建立直线回归方程,通过直线回归方程对参加实验室进行公式校准,最后将20份比对样本品及5份不同浓度新鲜全血调查品代入直线回归方程得到校准后的结果。比对通过判断标准按照美国国家糖化血红蛋白标准化计划(NGSP)认证Ⅱ级定值检测实验室的要求:糖化血红蛋白测定结果与定值偏倚的95%可信区间误差0.75%,比对系统与参比系统检测值百分偏倚的绝对值小于6%;通过检测实验室之间定值全血标本比对传递一致性,使比对区域范围内的结果有可比性,采用室间质评方式对五份新鲜全血样本进行检测,计算其标准差及变异系数,评估糖化血红蛋白一致性建立前后的改进情况。结果:调查获知泸州地区主要县级以上七家医院糖化血红蛋白使用情况,其中A医院检验科为美国普莱莫斯糖化分析仪,F医院检验科使用国产上海惠中MQ-2000PT分析仪,G医院检验科为日本东芝全自动生化分析仪,其余4家医疗机构使用美国BIORAD D-10型糖化分析仪,同时了解到各医院有关室内质量控制都在开展,由于省内室间质评未包含糖化血红蛋白项目,因此被调查七家医院均未参加,各大医院仪器维护保养状态良好,仪器保养记录完整;泸州地区的糖化血红蛋白一致性实验结果:A,B,C,D,E,F,G七家医院与四川医科大学附属第一医院医学检验科比对线形回归方程分别为:Y=1.0254X-0.2697,Y=1.0336X-0.3726,Y=0.9941X-0.0946,Y=0.9965X-0.1297,Y=1.0178X+0.0109,Y=0.9825X+0.1615,Y=0.9792X+0.2076;相关系数为:R2=0.9958,R2=0.9959,R2=0.993,R2=0.9986,R2=0.9975,R2=0.9967,R2=0.9953;95%可信区间误差均小于0.75%,分别为:(-0.28%,0.44),(-0.25%,0.49),(-0.28%,0.56),(-0.03%,0.34),(-0.41%,0.12),(-0.32%,0.26),(-0.42%,0.32)。结论:初步建立的泸州地区糖化血红蛋白具有较好的一致性,所在市县范围内检测结果无区别,实现糖化血红蛋白的标准化,促进糖尿病临床诊治一致性。
[Abstract]:Objective: This paper aims to investigate the basic situation of glycosylated hemoglubin (GHb) related projects in Luzhou and lay the foundation for establishing the consistency of the results of glycosylated hemoglobin in Luzhou; based on the BIORAD D-10 glycosylated hemoglobin analyzer of the First Affiliated Hospital of Sichuan Medical University in 2015, The consistency of the results of glycated hemoglobin in the municipal medical institutions of Luzhou county and the mutual recognition of the results were realized. The trend of dispersion of the fresh whole blood samples before and after the establishment of glycosylated hemoglobin consistency was evaluated, including the standard deviation and the coefficient of variation. Methods: seven hospitals at the municipal level in Luzhou county (A, B, C, D,) were investigated by questionnaire. E, F, G letters represent the basic situation of the glycosylated hemoglobin analyzer; the glycated hemoglobin instrument of the First Affiliated Hospital of Sichuan Medical University is the reference system. The other participating laboratories are used as the comparison system, and the first medical college affiliated to Sichuan Medical University provides 3 copies of the calibrated fresh whole blood and 20 comparison samples. This product and 5 different concentrations of fresh whole blood samples, first participated in the laboratory determination of 3 fresh whole blood calibrations, 20 comparative samples and 5 fresh whole blood samples of different concentrations. Secondly, a linear regression equation was established for the results of the 3 fresh whole blood calibrations in each laboratory and the calibrated fresh whole blood, through the linear regression equation. The calibration of the formula was carried out in the laboratory. Finally, the calibration results were obtained by replacing 20 samples of samples and 5 fresh whole blood samples with different concentrations of fresh whole blood. Compared to the requirements of the United States National glycosylated hemoglobin standardization plan (NGSP) certification grade II test laboratory, glycosylated hemoglobin was compared. The 95% confidence interval error of the test results and the fixed value bias was 0.75%, the absolute value of the ratio of the comparison system and the reference system was less than 6%, and the results were comparable to the results in the regional range by the determination of the whole blood sample ratio between the laboratories and the five fresh whole blood samples by interventricular quality assessment. Test, calculate its standard deviation and coefficient of variation, evaluate the improvement of glycated hemoglobin before and after the establishment of consistency. Results: the investigation was informed of the use of glycated hemoglobin in seven hospitals at the county level and above in Luzhou, among which the A hospital inspection department was the American Moss saccharification analyzer, and the F hospital laboratory used the home-made Shanghai Huizu MQ-2000PT The analyzer, G hospital inspection department is the Japanese Toshiba automatic biochemical analyzer, the other 4 medical institutions use the United States BIORAD D-10 saccharification analyzer. At the same time, we know that all the hospitals' indoor quality control is being carried out. Because the provincial room quality assessment is not included in the glycosylated hemoglobin item, all the seven hospitals have not participated in all the major doctors. A, B, C, D, E, F, G seven hospitals and the First Affiliated Hospital of Sichuan Medical University Kobe's linear regression equation are Y= 1.0254X-0.2697, Y=1.0336X-0.3726, Y=0.9941X-0.0946, Y=0.9965X-0.1297. 0178X+0.0109, Y=0.9825X+0.1615, Y=0.9792X+0.2076; the correlation coefficients are R2=0.9958, R2=0.9959, R2=0.993, R2=0.9986, R2=0.9975, R2=0.9967, R2=0.9953; 95% confidence interval errors are less than 0.75%, respectively (-0.28%, 0.44), (-0.25%, 0.49), (0.34), (0.12, 0.26), (0.26), (0.32, 0.32). Conclusion: preliminary establishment The glycosylated hemoglobin in Luzhou has a good consistency. There is no difference in the results of the city and county, and the standardization of glycosylated hemoglobin can promote the consistency of the clinical diagnosis and treatment of diabetes.

【学位授予单位】：四川医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.11

【参考文献】