本文選題：糖化血紅蛋白 + 性能評價��； 參考：《廣州中醫(yī)藥大學(xué)》2015年碩士論文

【摘要】：第一部分4種不同檢測系統(tǒng)檢測HbA1c的性能驗證目的：對4種不同檢測系統(tǒng)常規(guī)檢測HbAlc的分析性能進行驗證。方法：對4種不同檢測系統(tǒng)檢測HbAlc進行精密度、正確度、線性、方法學(xué)比對和分析干擾進行驗證。結(jié)果：4種檢測系統(tǒng)的批內(nèi)不精密度：0.32-1.9%,總不精密度：0.93-1.94%;4種系統(tǒng)檢測4份不同濃度全血標本的HbAlc,結(jié)果與IFCC參考方法檢測結(jié)果比較,偏移小于5mmol/mol或0.5%；在4.2%-13.3%范圍內(nèi)線性相關(guān)良好(r=0.99)；在80份全血標本的比對中,4種方法測定HbAlc結(jié)果明顯相關(guān)(r0.97,P0.001),在濃度為6.5%處的偏移均小于5mmol/mol (0.5%);4種系統(tǒng)在總膽紅素(TBIL)445.50umolL、甘油三酯(TG)10.21mmol/L、膽固醇(CHOL)10.29mmol/L、TG和CH0L,19.10和10.90mmol/L、葡萄糖(GLU)277.8mmol/L、維生素C (VitC) 50mg/mL、阿司匹林(aspirin)33.3mg/mL下檢測HbAlc沒有干擾,不同濃度的HbF則存在干擾,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%)。結(jié)論：這4種不同檢測系統(tǒng)在檢測HbAlc中顯示出良好的分析性能,可應(yīng)用于臨床標本的檢測。第二部分地貧對4種不同檢測系統(tǒng)檢測HbA1c的影響和Capillarys 2FP對地貧的篩查價值目的：探討地貧對4種不同檢測系統(tǒng)檢測HbAlc的影響以及Capillarys 2FP在測定HbAlc過程中對地貧篩查的價值。方法：各選取99例正常人群和地貧患者的標本分別在4種不同檢測系統(tǒng)上檢測HbAlc,比較各系統(tǒng)結(jié)果的差異以及不同類型的地貧標本的結(jié)果與正常人群的結(jié)果的差異；選取不同類型地貧標本中的10例,采用參考方法高效液相色譜-毛細管電泳法進行賦值,判斷各系統(tǒng)結(jié)果的準確性；通過Capillarys 2FP檢測不同類型地貧的HbA2值,通過作ROC曲線確定篩查地貧的cut-off值。結(jié)果：正常人群標本4種檢測系統(tǒng)檢測結(jié)果均無差別,P0.05。地貧標本,PremierHb9210和Roche c501檢測結(jié)果比正常人群結(jié)果低,Tosoh G8檢測結(jié)果則偏高P0.01,而Capillarys 2FP檢測結(jié)果則無差別,P0.05。 Premier Hb9210、 Capillarys 2FP和Roche c501檢測靜止型α-地貧和中間型α-地貧結(jié)果均與正常人群標本無差別,P0.05,而檢測HbH病和輕型β-地貧檢測結(jié)果則明顯低于正常人,P0.01。各系統(tǒng)檢測10例地貧標本結(jié)果與參考方法比較,Premier Hb9210、 Roche c501和Capillarys 2FP的相對偏差均5 mmol/mol或者0.5%,但有4個HbH病的標本Capillarys 2FP未檢測出結(jié)果。而Tosoh G8檢測結(jié)果中,有7個標本的結(jié)果與靶值比較,相對偏差5 mmol/mol或者0.5%。Capillarys 2FP檢測地貧標本的HbA2結(jié)果,通過ROC曲線得出,篩查α-地貧最佳的HbA2值為≤2.2%,此時ROC曲線面積AUC=0.85,敏感度為80%,特異度為74.5%。篩查β-地貧最佳的HbA2值為3%,此時ROC曲線面積AUC=1.0,敏感度為100%,特異度為100%結(jié)論：地貧標本對Tosoh G8檢測HbAlc結(jié)果有影響,靜止型α-地貧和中間型α-地貧對Premier Hb9210、Capillarys 2FP和Roche c501檢測結(jié)果無影響,HbH病和輕型β-地貧則對結(jié)果有影響；Capillarys 2FP在檢測HbAlc過程中具有篩選地貧的價值。
[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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R446.1

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