缺血修饰白蛋白检测方法的分析性能评价

应用湖南长沙颐康科技开发有限公司开发的缺血修饰白蛋白(ischemia modified albumin,IMA)检测试剂盒,在OLYMPUS AU5400全自动生化分析仪上设计合理的实验参数,建立白蛋白-钴结合力(albumin cobalt binding,ACB)实验检测系统,用比色法测定IMA的浓度,参考美国临床实验室标准化协会(clinical and laboratory standards institute,CLSI)系列文件的要求,评价IMA检测系统的线性实验、精密度(用批内和批间变异系数CV表示)、干扰试验;收集表征健康人群血清(366例),检测该人群血清IMA浓度,建立本实验室的参考区间.结果表明白蛋白-钴结合线性分析方程式为y=1.470 6x+5.260 6,R2=0.974 8,线性良好;IMA的高、中、低值样本的批内CV和批间CV分别为3.01%和3.24%、2.63%和4.36%及4.77%和5.59%,均小于厂商说明书声明的5.06%和6.72%,表明本实验检测系统精密度性能符合临床实验室质量目标管理的要求.高、低两个浓度标本在干扰物为临床标本时可能出现的最高含量(甘油三酯8.5mmol/L、胆红素75.2mmol/L、血红蛋白160g/L)结果测定值均在95%置信区间内,表明在临床实验室该方法抗干扰性能良好;健康人群IMA的本实验室的参考区间为IMA>65.2U/mL.

Performance evaluation of ischemia modified album detection method

Abstract： Employed albumin cobalt binding （albumin cobalt binding, ACB） test （produced by YiKang Science and Technology Development Co. Ltd, Changsha）, designed rational parameters on the OLYMPUS AU 5400 automatic biochemical analyzer. The establishment of ACB test, colorimetric assay for detection of ischemia modified albumin（IMA） system refered to the Clinical and Laboratory Standards Institute（Clinical and Laboratory Standards Institute, CI.SI） EP documentation requirements. Evaluated the precision of IMA detection（with intra and inter specific variation coefficient,CV）, linearity and anti interference test. Selected healthy volunteers（366 cases）, established the health population IMA biological reference range by measured the serum IMA level. The linear equation of albumin cobalt binding test was y=1.470 6x＋5. 260 6, R2= 0. 974 8. The high, medium and low different concentrations of IMA specimens were detected, the intra and inter precision of IMA detection were 3.01%＆ 3.24%,2. 63%＆ 4. 36% and 4. 77%＆ 5. 59%. When high, low concentrations of two specimens for clinical specimens in interference may occur（the highest content of triglyceride, 75. 2 mmol/I., bilirubin 8. 5 mmol/L and hemoglobin 160 g/L）, the results of the measured values were in a 95% confidence interval, demonstrated the method be very good anti interference performance in clinical laboratory. The range of biological reference of IMA from health population was IMA〉65. 2 U/mL.