本文選題：糖化血紅蛋白 + 一致性��； 參考：《四川醫(yī)科大學(xué)》2015年碩士論文

【摘要】：目的:本文旨在調(diào)查瀘州地區(qū)糖化血紅蛋白(glycosylated hemoglubin,GHb)相關(guān)項目的基本情況,為建立瀘州地區(qū)糖化血紅蛋白檢測結(jié)果的一致性奠定基礎(chǔ);2015年四川醫(yī)科大學(xué)附屬第一醫(yī)院檢驗科BIORAD D-10型糖化血紅蛋白分析儀為基礎(chǔ),建立瀘州縣市級醫(yī)療機構(gòu)糖化血紅蛋白結(jié)果的一致性,實現(xiàn)檢測結(jié)果的相互認(rèn)可;通過評價新鮮全血調(diào)查品在糖化血紅蛋白一致性建立前后的離散度趨勢:包括標(biāo)準(zhǔn)差和變異系數(shù)。方法:采用問卷調(diào)查方式了解瀘州縣市級七家醫(yī)院(以A,B,C,D,E,F,G字母代表七家醫(yī)院名稱)糖化血紅蛋白分析儀的基本情況;四川醫(yī)科大學(xué)附屬第一醫(yī)院醫(yī)學(xué)檢驗科糖化血紅蛋白儀為參考系統(tǒng),其他參加實驗室作為比對系統(tǒng),由四川醫(yī)科大學(xué)附屬第一醫(yī)院提供3份賦值新鮮全血校準(zhǔn)品,20份比對樣本品及5份不同濃度新鮮全血調(diào)查品,首先參加實驗室測定3份新鮮全血校準(zhǔn)品,20份比對樣本品及5份不同濃度新鮮全血調(diào)查品,其次將各實驗室3份新鮮全血校準(zhǔn)品測定結(jié)果與賦值新鮮全血校準(zhǔn)品建立直線回歸方程,通過直線回歸方程對參加實驗室進行公式校準(zhǔn),最后將20份比對樣本品及5份不同濃度新鮮全血調(diào)查品代入直線回歸方程得到校準(zhǔn)后的結(jié)果。比對通過判斷標(biāo)準(zhǔn)按照美國國家糖化血紅蛋白標(biāo)準(zhǔn)化計劃(NGSP)認(rèn)證Ⅱ級定值檢測實驗室的要求:糖化血紅蛋白測定結(jié)果與定值偏倚的95%可信區(qū)間誤差0.75%,比對系統(tǒng)與參比系統(tǒng)檢測值百分偏倚的絕對值小于6%;通過檢測實驗室之間定值全血標(biāo)本比對傳遞一致性,使比對區(qū)域范圍內(nèi)的結(jié)果有可比性,采用室間質(zhì)評方式對五份新鮮全血樣本進行檢測,計算其標(biāo)準(zhǔn)差及變異系數(shù),評估糖化血紅蛋白一致性建立前后的改進情況。結(jié)果:調(diào)查獲知瀘州地區(qū)主要縣級以上七家醫(yī)院糖化血紅蛋白使用情況,其中A醫(yī)院檢驗科為美國普萊莫斯糖化分析儀,F醫(yī)院檢驗科使用國產(chǎn)上海惠中MQ-2000PT分析儀,G醫(yī)院檢驗科為日本東芝全自動生化分析儀,其余4家醫(yī)療機構(gòu)使用美國BIORAD D-10型糖化分析儀,同時了解到各醫(yī)院有關(guān)室內(nèi)質(zhì)量控制都在開展,由于省內(nèi)室間質(zhì)評未包含糖化血紅蛋白項目,因此被調(diào)查七家醫(yī)院均未參加,各大醫(yī)院儀器維護保養(yǎng)狀態(tài)良好,儀器保養(yǎng)記錄完整;瀘州地區(qū)的糖化血紅蛋白一致性實驗結(jié)果:A,B,C,D,E,F,G七家醫(yī)院與四川醫(yī)科大學(xué)附屬第一醫(yī)院醫(yī)學(xué)檢驗科比對線形回歸方程分別為: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;相關(guān)系數(shù)為:R2=0.9958,R2=0.9959,R2=0.993,R2=0.9986,R2=0.9975,R2=0.9967,R2=0.9953;95%可信區(qū)間誤差均小于0.75%,分別為:(-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)。結(jié)論:初步建立的瀘州地區(qū)糖化血紅蛋白具有較好的一致性,所在市縣范圍內(nèi)檢測結(jié)果無區(qū)別,實現(xiàn)糖化血紅蛋白的標(biāo)準(zhǔn)化,促進糖尿病臨床診治一致性。
[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.

【學(xué)位授予單位】：四川醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R446.11

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