两种血细胞分析系统检测结果的可比性研究

Two Blood Cell Analysis System Testing Results Comparability Studies

目的 探讨Beckman Coulter AC.T 5diff血细胞分析系统和Abbot Cell-Dyn3200血细胞分析系统测定结果的可比性.方法 参考美国临床实验室标准化协会（CLSI）的EP9-A2文件[1],选取检测项目[白细胞（WBC）、红细胞（RBC）、血红蛋白（HGB）、血小板（PLT）]覆盖各医学决定水平的新鲜全血40份.样本在非连续5天中,每天以1～8,8～1的顺序在已校准的目标系统和检测系统同时完成检测.各项目检测结果做离群值检验,检测系统双份检测的均值（i）对目标系统双份检测的均值（i）做线性回归并计算线性回归方程,两个系统双份测定的均值差（i-i）对目标系统双份检测的均值（i）作偏差图.根据线性回归方程计算各项目医学决定水平的偏倚（bias）和不正确度（bias%）,以1/2CLIA＇88为实验室允许总误差（TEa）的临床可接受范围判断检测系统与目标系统检验之间的可比性.结果 离群值检验通过.两个血细胞分析系统的WBC检测具有可比性.RBC,PLT的低医学决定水平检测超出临床可接受范围,HGB的低、高医学决定水平检测均超出临床可接受范围,不具有可比性.结论 实验室内各血细胞分析系统之间的比对试验非常必要.EP9-A2文件在评价不同血细胞分析系统检测的可比性具有很好的参考价值,值得推广和应用.

Objective To investigate comparability of results between Beckman Coulter AC. T 5diff blood cell analysis system and Abbot Cell-Dyn 3200 blood cell analysis system. Methods By referring to the U. S. Clinical and Laboratory Stan- dard Institute （CLSI） EP9-A2 document,forty fresh whole blood samples were selected whose test parameters [white blood cell （WBC）,red blood cell （RI^C）,hemoglobin （HGB）,platelet （PLT）] were representative to the suggested distri- bution in EP9-A2. In non-consecutive five days,these samples were measured simultaneously in the order of 1-8 and 8- 1 using the pre-calibrated comparative system and the test system. Outlier analysis was performed and linear regression analysis was performed using mean value of duplicated measure in test system （Yi） and comparative system （Xi）. The Bias plot was constructed using the delta of mean（Yi--Xi）against mean of the comparative system （Xi）. Bias and bias% was calculated according to the linear regression equation. Comparability between test system and target system was assessed according to 1/2 CLIA＇ 88 standard as clinical acceptable TEa. Results All the four parameters passed outlier tests. Com- parability test passed in the white blood cell. However,the low medical level of RBC,PLT and both high and low level of HGB exceeded the acceptable level of comparability. Conclusion Comparability test for different blood cell analysis systems is highly necessary. EP9-A2 document is a favorable reference for comparability test in blood cell analysis systems and should be generally applied.