2种不同试剂检测血清免疫球蛋白结果的可比性及偏倚评估

目的进行2种不同免疫球蛋白诊断试剂对血清免疫球蛋白测定结果的可比性及偏倚评估研究,为血清免疫球蛋白测定的标准化和临床实验室认可提供实验数据。方法参考美国临床和实验室标准协会(CLSI)的EP9A2文件,分别用执诚试剂和优利特试剂在HITACHI7600-010全自动生化分析仪上测定免疫球蛋白IgG、IgA和IgM,以执诚试剂为对照组,优利特试剂为实验组。用线性回归统计法分析对照组(Y)和实验组(X)测定结果决定水平处的方法间误差,以美国临床实验室修正法规(CLIA′88)规定的室间质量评价允许误差范围的1/2为标准,判断不同试剂的临床可接受性。结果两种试剂对患者血清免疫球蛋白测定结果显示,方法内重复性良好,无离群点,除IgA在决定水平处的系统误差不能被接受外,其余项目测定结果的偏差临床可以接受。结论当同一实验室同一检验项目存在2个或以上的试剂时,应进行方法比对和偏差评估,判断其临床可接受性,以保证检验结果的可比性。

Comparability and bias evaluation of serum immunoglobulin levels determined by two different regents

Objective To evaluate the comparability and the bias of serum immunoglobulin results determined by two different diagnostic regents,whether the outcome of the immunoglobulin comparable to the standardization of serum immunoglobulins and clinical laboratory authorized to provide the experimental data.Methods According to the NCCLS EP9-A2 document,the immunoglobulin concentrations determination were carried out by HITACHI7600-010 automatic biochemical analyzer with zhicheng regent and youlite regent respectively,the control group was zhicheng reagent,the experimental group was youlite reagent.By linear regression analysis method(Y) and comparison(X) determined the relative mean Office deviation or medicine department decided to approach the level of inter-error in order to amend legislation in the U.S.clinical laboratory(CLIA′88) provides quality assessment of the permissible error range of 1/2 as the standard,a different detection regent to determine the clinical acceptability.Results Two types of immunoglobulin diagnostic regents showed that,there were not existence outlier.Detection regents in addition to the IgA results and comparison between the error or the mean relative deviation of the department can not be accepted,the remaining items of the deviation of clinical measurements is acceptable.Conclusion When the same laboratory the same tests over the existence of two detection regents,should be carried out and bias than on assessment,to determine its clinical acceptability,in order to ensure comparability of test results.