摘要
目的研究Bio-Rad D10糖化血红蛋白仪更换新色谱柱后活化的平衡时间,以及对糖化血红蛋白（HbA1c）测定准确性的影响。方法新色谱柱安装并活化后校标使用,每3h测1次卫生部临床检验中心HbA1c室间质评标本,连续比较相邻两时间点间结果的差异。无显著性差异后再次校标测试,比较校标前后准确性的变化;以室间质评通过标准（靶值±8%×靶值）为水平,绘制各时间点偏倚散点图及其绝对平均值的趋势线,根据范围大小及线性变化判断活化平衡时间;为排除进样对活化时间的干扰,用另一根同批号的新色谱柱做验证实验,即经活化静置该段平衡时间后校标测试,观察其变异系数（CV）及与靶值的偏差,以检测指南中的质量目标来判断其测定准确性。结果 0、3、6h间比较,差异有统计学意义（P〈0.05）,6h与9h比较及9h校标后与12h比较,差异均无统计学意义（P〉0.05）。偏倚从-11.3%-28.9%逐渐下降为-5.7%-11.6%后趋于平稳,6h处为拐点,校标后继续维持在-1.1%-4.3%。校标前后两段时间偏倚绝对值比较,差异有统计学意义（P〈0.05）;验证实验批内和日间CV分别为1.58%-1.87%和1.72%-2.64%,偏差在±5%以内,符合质量目标的要求。结论 Bio-Rad D10糖化血红蛋白仪色谱柱活化6h已达到平衡,未充分活化即开始校标测定,可导致测定结果不准确。
Objective To study the activation equilibrium time after replacing the chromatographic column in the Bio-Rad D10 glycated hemoglobin analyzer,and its influence on the detection accuracy of glycosylated hemoglobin（HbA1c）.Methods The new chromatographic column was installed,activated,calibrated and used.Then the HbA1 cexternal quality assessment（EQA）samples provided by of the Clinical Laboratory Center of the Ministry of Health（NCCL）were detected once per 3h.The difference of the detection results was compared between the two adjacent time points.The calibration and detection were performed again when without significant difference,the change of accuracy was compared before and after calibration;the bias scattered plot at each time point and the trend line of its average absolute values were drawn with the EQA passing criteria（target value±8%×target value）as the level,the activation equligrium time was judged according to the range size and linear change;another new chromatographic column with the same batch was used to perform the verification test for excluding the interference of sample injection on the activstion time,i.e.after activation and atanding for this equilibrium time,then the calibration and detection were conducted,the bias of coefficient of variation（CV）with the target value was observed,the quality target in the detection duidance was detected for determining its accuracy.Results The difference among the time points of 0,3,6hwas statistically significant（P〈0.05）,there were no statistically significant differences between6 hand 9hand between 9hand 12h（P〈0.05）.The bias was gradually decreased from-11.3%-28.9% to-5.7%-11.6% and then trended to stabilize,the inflection point was at 6h,after calibration,the bias continueously maintained at-1.1%-4.3%.The absolute values of bias had statistically significant difference in the two time perids before and after calibration（P 〉0.05）.In the verification tests,the intra and inter day CV were1.58%-1.87% and 1.72%-2.64%,and the bias was less within ±5%,which were accordance with the requirements of quality objectives.Conclusion The chromatographic column of the Bio-Rad D10HbA1 canalyzer can reach equilibrium.Starting calibration and detection without sufficient activation could lead to inaccuracy of the detection results.
出处
《检验医学与临床》
CAS
2016年第2期176-178,共3页
Laboratory Medicine and Clinic
基金
四川省卫生厅科研项目(100330)
