【摘要】 目的探讨速率散射比浊法和透射比浊法测定血清免疫球蛋白(Ig)的结果偏差及其纠正措施。方法参考EP9-A文件,对两种方法检测系列血清标本IgG、IgA、Ig M的结果进行对比及偏差评估;并将透射比浊法使用的校准品分别用I MMAGE免疫化学系统重新定值,透射法量值溯源而构成新的检测体系,其检测结果与散射法的结果进行偏差评估。结果两种方法测定IgG,在一定线性范围内,预期偏差可以接受;IgA测定结果透射比浊法均低于速率散射比浊法,两方法的预期偏差尚可以接受,但低于0·6g/L时,预期偏差可达15·6%;两种方法测定Ig M的结果差异很大,在给定值范围内相对误差平均为42%,预期偏差不能接受。新的透射比浊检测体系中,测定Ig M的系统偏差得到纠正,但IgA的预期偏差明显增大。结论建立良好的检测体系及其准确度性能评价是检测结果准确性的根本保证。更多还原

【Abstract】 Objective To study the bias of serum immunoglobin(Ig) results measured with nephelometry and transmission turbidimetry and the measure to rectify the bias.Methods The comparability and evaluation of bias on serum IgG,IgA,IgM were performed with different detection systems according to the profile NCCLS-EP9-A;the calibrator of transmission turbidimetry was calibrated with IMMAGE immunochemistry system,the new detection system and bias estimation was established.Results When measuring the serum Ig by nephelometuy and transmission turbidimetry,the outcome bias of IgG was accepted in the linear range.The results of IgA by transmission turbidimetry were lower than that by nephelometry,their outcome bias was accepted,but<0.6 g/L,the outcome bias could be more than 15.6%.The average relativity bias of IgM could reach 42% and outcome bias was not acceptable. In new detection system,the systematic error of IgM was rectified,but the outcome bias of IgA increased.Conclusion In order to ensure the accuracy and the stability of the rest outcome,the excellent detection system and method of comparison and bias evaluation should be employed.更多还原