不同检测系统检测糖化血红蛋白的实验研究

发布时间：2018-06-28 01:46

  本文选题：糖化血红蛋白 + 性能评价　； 参考：《广州中医药大学》2015年硕士论文

【摘要】：第一部分4种不同检测系统检测HbA1c的性能验证目的：对4种不同检测系统常规检测HbAlc的分析性能进行验证。方法：对4种不同检测系统检测HbAlc进行精密度、正确度、线性、方法学比对和分析干扰进行验证。结果：4种检测系统的批内不精密度：0.32-1.9%,总不精密度：0.93-1.94%;4种系统检测4份不同浓度全血标本的HbAlc,结果与IFCC参考方法检测结果比较,偏移小于5mmol/mol或0.5%；在4.2%-13.3%范围内线性相关良好(r=0.99)；在80份全血标本的比对中,4种方法测定HbAlc结果明显相关(r0.97,P0.001),在浓度为6.5%处的偏移均小于5mmol/mol (0.5%);4种系统在总胆红素(TBIL)445.50umolL、甘油三酯(TG)10.21mmol/L、胆固醇(CHOL)10.29mmol/L、TG和CH0L,19.10和10.90mmol/L、葡萄糖(GLU)277.8mmol/L、维生素C (VitC) 50mg/mL、阿司匹林(aspirin)33.3mg/mL下检测HbAlc没有干扰,不同浓度的HbF则存在干扰,Capillarys 2FP (10%), Tosoh G8(校正前5%,校正后30%),Premier Hb9210(15%)和Roche c501(校正前5%,校正后20%)。结论：这4种不同检测系统在检测HbAlc中显示出良好的分析性能,可应用于临床标本的检测。第二部分地贫对4种不同检测系统检测HbA1c的影响和Capillarys 2FP对地贫的筛查价值目的：探讨地贫对4种不同检测系统检测HbAlc的影响以及Capillarys 2FP在测定HbAlc过程中对地贫筛查的价值。方法：各选取99例正常人群和地贫患者的标本分别在4种不同检测系统上检测HbAlc,比较各系统结果的差异以及不同类型的地贫标本的结果与正常人群的结果的差异；选取不同类型地贫标本中的10例,采用参考方法高效液相色谱-毛细管电泳法进行赋值,判断各系统结果的准确性；通过Capillarys 2FP检测不同类型地贫的HbA2值,通过作ROC曲线确定筛查地贫的cut-off值。结果：正常人群标本4种检测系统检测结果均无差别,P0.05。地贫标本,PremierHb9210和Roche c501检测结果比正常人群结果低,Tosoh G8检测结果则偏高P0.01,而Capillarys 2FP检测结果则无差别,P0.05。 Premier Hb9210、 Capillarys 2FP和Roche c501检测静止型α-地贫和中间型α-地贫结果均与正常人群标本无差别,P0.05,而检测HbH病和轻型β-地贫检测结果则明显低于正常人,P0.01。各系统检测10例地贫标本结果与参考方法比较,Premier Hb9210、 Roche c501和Capillarys 2FP的相对偏差均5 mmol/mol或者0.5%,但有4个HbH病的标本Capillarys 2FP未检测出结果。而Tosoh G8检测结果中,有7个标本的结果与靶值比较,相对偏差5 mmol/mol或者0.5%。Capillarys 2FP检测地贫标本的HbA2结果,通过ROC曲线得出,筛查α-地贫最佳的HbA2值为≤2.2%,此时ROC曲线面积AUC=0.85,敏感度为80%,特异度为74.5%。筛查β-地贫最佳的HbA2值为3%,此时ROC曲线面积AUC=1.0,敏感度为100%,特异度为100%结论：地贫标本对Tosoh G8检测HbAlc结果有影响,静止型α-地贫和中间型α-地贫对Premier Hb9210、Capillarys 2FP和Roche c501检测结果无影响,HbH病和轻型β-地贫则对结果有影响；Capillarys 2FP在检测HbAlc过程中具有筛选地贫的价值。
[Abstract]:The first part of the 4 different detection systems test HbA1c performance verification purpose: to verify the analysis performance of the 4 different detection systems routine detection of HbAlc. Method: 4 different detection systems to detect HbAlc precision, accuracy, linearity, methodological comparison and analysis of interference verification. Results: 4 detection systems are not in batch. Precision: 0.32-1.9%, total inseminal density: 0.93-1.94%; 4 systems detected 4 HbAlc of all blood samples of different concentrations. The results were less than 5mmol/mol or 0.5% compared with the IFCC reference method; in the 4.2%-13.3% range, the linear correlation was good (r=0.99); in the comparison of 80 whole blood specimens, 4 methods determined the obvious phase of HbAlc results. The migration of (r0.97, P0.001) is less than 5mmol/mol (0.5%) at the concentration of 6.5%; the 4 systems are in the total bilirubin (TBIL) 445.50umolL, triglyceride (TG) 10.21mmol/L, cholesterol (CHOL) 10.29mmol/L, TG and CH0L, 19.10 and 10.90mmol/L. Interference, different concentrations of HbF have interference, Capillarys 2FP (10%), Tosoh G8 (correction 5%, correction 30%), Premier Hb9210 (15%) and Roche C501 (correction 5%, correction 20%). Conclusion: these 4 different detection systems in the detection of HbAlc showed good analysis performance, can be applied to clinical specimens detection. Second part of the poor to 4 The effects of different detection systems on detecting HbA1c and the value of Capillarys 2FP for the screening of land poverty: the influence of 4 different detection systems on the detection of HbAlc and the value of Capillarys 2FP for the detection of poverty in the HbAlc process. Methods: the specimens of 99 normal people and the poor patients were selected in 4 different tests. On the test system, HbAlc was detected, the differences of the results of various systems and the differences between the results of the different types of ground poor specimens and the results of the normal population were compared. 10 cases of different types of ground poor specimens were selected, and the accuracy of the results of each system was judged by the reference method high performance liquid chromatography capillary electrophoresis, and the results were judged by Capillarys 2FP. The HbA2 values of different types of land poverty were detected and the cut-off values were determined by ROC curve. Results: there was no difference between the results of 4 detection systems in normal population specimens, P0.05. poor specimens, PremierHb9210 and Roche C501 results were lower than those of normal population, Tosoh G8 test results were higher P0.01, and Capillarys 2FP test results. The results of P0.05. Premier Hb9210, Capillarys 2FP and Roche C501 were not different from those of normal population, P0.05, but the results of detecting HbH disease and light beta poor were obviously lower than those of normal people. The results of 10 cases of P0.01. were compared with those of reference, Premier H. The relative deviations of b9210, Roche C501 and Capillarys 2FP were 5 mmol/mol or 0.5%, but 4 specimens of HbH disease were not detected in Capillarys 2FP. And in the Tosoh G8 test results, the results of 7 specimens were compared with the target values, and the relative deviation was 5 mmol/mol or the results of testing the poor specimens. The optimal HbA2 value for screening alpha poverty was less than 2.2%, at this time the ROC curve area was AUC=0.85, the sensitivity was 80%, the best degree of specificity was 3% for 74.5%., the ROC curve area AUC=1.0, the sensitivity of 100%, and the specificity of 100% conclusion: the ground poor specimens had an influence on the Tosoh G8 detection HbAlc results, the static alpha poor and intermediate alpha alpha. Land poverty had no effect on the results of Premier Hb9210, Capillarys 2FP and Roche C501. HbH disease and light beta poor were the result of the results, and Capillarys 2FP had the value of screening the poor in the detection of HbAlc.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.1

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