CAJ | 학술논문

目的探讨免疫抑制透射比浊法(TINIA)和离子交换高效液相色谱法(HPLC)测定糖化血红蛋白(HbAlc)的相关性及其临床应用.方法根据美国临床实验室标准化委员会(NCCLS)实验评价方案进行精密度、线性、方法比对及偏倚实验,结果采用回归方程和t检验进行统计分析.结果 HbAlc浓度在3.9％～15.2％范围时无论是TINIA还是HPLC法,都有良好的重复性和线性关系,但以HPLC法更佳.偏倚对比分析显示在高水平TINIA与HPLC成负偏倚,低水平时成正偏倚.在方法比对实验中的两组数据没有统计学意义(P＞0.05),以TINIA测定结果为Y轴、HPLC的为X轴进行相关性分析:y=0.7857x+1.264,r =0.89两者呈正相关.结论通过方法学评价,本实验室两种方法测定HbAlc的精密度、线性范围符合临床要求,结果具有可比性；HPLC法的重复性更佳、更适合临床用于糖尿病的治疗监测.
목적 탐토면역억제투사비탁법(TINIA)화리자교환고효액상색보법(HPLC)측정당화혈홍단백(HbAlc)적상관성급기림상응용.방법 근거미국림상실험실표준화위원회(NCCLS)실험평개방안진행정밀도、선성、방법비대급편의실험,결과채용회귀방정화t검험진행통계분석.결과 HbAlc농도재3.9％～15.2％범위시무론시TINIA환시HPLC법,도유량호적중복성화선성관계,단이HPLC법경가.편의대비분석현시재고수평TINIA여HPLC성부편의,저수평시성정편의.재방법비대실험중적량조수거몰유통계학의의(P＞0.05),이TINIA측정결과위Y축、HPLC적위X축진행상관성분석:y=0.7857x+1.264,r =0.89량자정정상관.결론 통과방법학평개,본실험실량충방법측정HbAlc적정밀도、선성범위부합림상요구,결과구유가비성；HPLC법적중복성경가、경괄합림상용우당뇨병적치료감측.
Objective To explore the correlation and clinical application of turbidimetric inhibition immunoassay (TINIA) and ion-exchange high-performance liquid chromatography (HPLC) for detecting glycosylated hemoglobin (HbAlC).Methods According to the criteria on NCCLS,experiments of precision,linearity,method comparison,and bias were conducted.The results were analyzed by regression equation and t test.Results The concentration of HbAlc at a range of 3.9％-15.2％ had good repeatability and linearity for TINIA or HPLC.Bias analysis showed TINIA and HPLC were negative bias as HbAlc was at higher level,and were positive bias at lower level.The data in the two groups had no statistical significance in method comparison (P＞0.05).The correlation analysis with the result of TINIA determination as Y axis and that of HPLC as X axis revealed y =0.7857x +1.264 and r =0.89,being positively related.Conclusions Through methodological evaluation,these two methods for determining HbAlC precision and linear range meets clinical requirement,with comparable results.HPLC,which has better repeatability,is more suitable for clinical monitoring in the treatment of diabetes mellitus.