不同检测系统IgG测定结果可比性探究.docVIP

不同检测系统IgG测定结果可比性探究 　【摘要】 目的 探讨同一临床实验室不同检测系统间免疫球蛋白G(IgG)测定结果是否具有可比性，为免疫球蛋白G测定的标准化提供实验数据。方法 参考NCCLS的EP9A文件，以德灵BNⅡ(仪器编号MY05)特定蛋白分析仪、德灵原装试剂、德灵校准品和德灵质控品组成的检测系统(已通过ISO15189实验室认可)为比较方法，以德灵BNⅡ(仪器编号MY19)特定蛋白分析仪、德灵原装试剂、德灵校准品和德灵质控品组成的检测系统为实验方法，用患者新鲜血清对IgG进行检测，计算试验方法(Y)和比较方法(X)之间的相对偏差(SE%)，以CLIA’88规定的室间质量评价允许误差范围的1/2为标准，判断不同检测系统的可比性。 结果 IgG测定结果各系统的误差临床可以接受。 结论 各检测系统测定IgG结果具有可比性。当同一实验室同一检验项目存在2个以上的检测系统时，应进行方法比对和偏差评估，以保证检验结果的可比性。 【关键词】 免疫球蛋白类; 检测; 比对试验 　　【Abstract】 Objective To investigate the comparability of immune globulin G (IgG) measurement results among different detection systems in the same clinical laboratory so as to provide experimental data for IgG standardization.Methods Based on NCCLS EP9A documents, the study took Dade Behring BNII specific protein analyzer (Instrument No. MY05), Dade Behring original reagent, Dade Behring calibration products and Dade Behring quality control product composition detection system (having passed the ISO15189 Laboratory Accreditation)as comparison means; Dade Behring BNII specific protein analyzer (Instrument No. MY19), Dade Behring original reagent, Dade Behring calibration products and Dade Behring quality control product composition detection system as means of experiment. Patients’ fresh serum was adopted to test IgG. The relative deviation (SE%)between the test method (Y) and the comparative method (X) was calculated, with 1/2 permissible error range of CLIA88 EQA as the standard, to determine the comparability of different detection systems.Results The IgG detection errors from various systems could be clinically accepted.Conclusion The IgG results from various detection systems are comparable in nature. When more than two detection systems are available in the same detection program in the same laboratory, methods should be compared and deviation assessed in order to ensure the comparability of the test result. 　　【Key words】 Immune globulins; Detection; Comparison experiment 　　IgG是血清主要的抗体成分，最常用的检测方法是散射比浊法