糖化血红蛋白五种检测方法的评价

发布时间：2018-11-08 07:55

【摘要】：目的将糖化血红蛋白测定的电泳法、亲和层析法、酶法和免疫法和HPLC法进行比较及评估,为临床医师及实验室在分析不同方法检测糖化血红蛋白结果时提供参考。方法正常对照组45例,DM患者44例,每一份标本在同样条件下用五种方法检测HbA1c,记录测定结果,用于对比分析;选择具有医学决定水平的正常和异常浓度的样本,分别采用5个样本,批内在同一天内重复20次;批间分别在7 d内进行10次测试。计算出批内和批间的均值、标准差和CV值;收集HbA1c高的糖尿病患者的抗凝血,同时收集当天健康者的抗凝血。在各种干扰物不同浓度的影响下,如果HbA1c的值上下浮动0.3%,则将视为受到干扰。采用SPSS16.0统计软件包对所测结果进行配对t检验(以HPLC组的实验数据为参照组),检验水准α=0.05。结果 5种方法中除外硼酸亲和法,其他四种方法均符合要求;5种方法在4.0%~14.2%范围内线性良好,实测值与理论值的相关系数(r)在0.971~0.996之间,其中HPLC法最好;当加入各种干扰因素时,结果显示HPLC法、酶法、胶乳凝集法测得的HbA1c值上下浮动0.1%,可见性能稳定、不易受到各种干扰物的影响;电泳受溶血影响非常大;硼酸亲和法对溶血标本显示浓度太低时测不出数,脂血标本显示浓度太高时测不出数;通过标本量、测定时间、CV、r等指标进行比较,HPLC法各种指标远优于其他方法。结论高校液相色谱法(HPLC)作为金标准,批内和批间精密度在所采用的5种方法中是最好的,其次为酶法和胶乳凝集法,而硼酸亲和法的重复性则相对较差。电泳法结果与实验人员扫描和对电泳的波峰判断有关,主观随意性较大,现将HPLC法和电泳法、亲和层析法、酶法和免疫法进行比较,旨在为临床医师及检验科实验室在分析不同方法检测糖化血红蛋白结果时提供参考。
[Abstract]:Objective to compare and evaluate glycosylated hemoglobin (HbA1c) by electrophoresis, affinity chromatography, enzyme and immunoassay and HPLC method, and to provide reference for clinical doctors and laboratories in analyzing the results of different methods for detection of glycosylated hemoglobin (HbA1c). Methods 45 cases of normal control group and 44 cases of DM patients, each specimen under the same conditions using five methods to detect the results of HbA1c, records, for comparative analysis; The normal and abnormal concentration samples with the level of medical determination were selected, 5 samples were used, 20 times were repeated within the same day, and 10 tests were carried out within 7 days between batches. The mean value, standard deviation and CV value of intra- and inter-batches were calculated, and the anticoagulant blood of diabetic patients with high HbA1c was collected, and the anticoagulant blood of healthy people on the same day was collected. If the value of HbA1c fluctuates up or down 0.3, it will be considered to be disturbed under the influence of different concentrations of interferences. SPSS16.0 software package was used to carry out the paired t test (taking the experimental data of HPLC group as the reference group), and the test level was 伪 = 0.05. Results except boric acid affinity method, the other four methods met the requirements. The linearity of the five methods is good in the range of 4.0% and 14.2%, and the correlation coefficient between the measured value and the theoretical value is between 0.971 and 0.996, among which the HPLC method is the best. When various interference factors were added, the results showed that the HbA1c values measured by HPLC method, enzymatic method and latex agglutination method fluctuated 0.1 up and down. The boric acid affinity method can not be measured when the concentration of hemolysis specimen is too low, but the fat blood sample can not be measured when the concentration is too high. Through the comparison of sample quantity, measuring time, CV,r and so on, all kinds of indexes of HPLC method are far superior to other methods. Conclusion (HPLC) is the gold standard in colleges and universities. The intra-and inter-batch precision is the best among the five methods, followed by enzymatic method and latex agglutination method, but the reproducibility of boric acid affinity method is relatively poor. The results of electrophoretic method were related to the scanning of the experimenter and the judgement of the peak of the electrophoretic wave, and the subjective randomness was relatively large. The HPLC method was compared with the electrophoresis method, the affinity chromatography method, the enzymatic method and the immunoassay. The aim is to provide reference for clinical doctors and laboratory laboratories in analyzing the results of different methods for detection of glycosylated hemoglobin (HbA1c).
【作者单位】：天津市天津医院检验科;天津市泰达医院检验科;
【分类号】：R446.62;R587.1

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