体育类生化室不同血细胞分析仪检测结果的比对研究

目的探讨样本来源以中值浓度为主的体育类检测实验室不同血细胞分析仪比对的方法。方法按照美国临床和实验室标准化协会(CLSI)EP9-A2文件要求,以ADVIA120(简称120)作为对比仪器,ADVIA2120i(简称2120)作为实验仪器,通过连续监测1年中6个批次的正常值质控和非正常值2质控的靶值建立数据,与随机选取的42例新鲜样本检测数据相结合,以白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、红细胞比容(HCT)、平均红细胞容积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)和血小板(PLT)作为检测项目指标,进行精密度、准确度和可比性研究。结果两台仪器所测项目的精密度(CV%值在0.9~5.0范围内波动)均在CLIA′88规定的1/4允许误差的可接受范围内;各检测项目的差异百分率均符合国际血液标准化委员会(ICSH)制定的标准;42例新鲜血液标本在两台仪器上测得数据进行回归分析结果显示,所有检测项目相关系数r值均大于0.97。结论通过运用连续监测1年中6个批次的正常值质控和非正常值2质控的靶值建立数据,与随机一组新鲜血液样本检测数据相结合的方法可以较好地实现体育类检测实验室对两台不同血细胞分析仪进行检测结果可比性和一致性的实验研究。

Comparative study of test results of different hematology analyzer in Sports Biochemistry Laboratories

Objective To explore the method of comparing different hematology analyzer in Sports Biochemistry Laboratories with the median concentration.Methods In accordance with the American Society of Clinical and Laboratory Standards Institute EP9-A2 document requirements,ADVIA120(120) was chosen as a standard comparative instrument,ADVIA2120i(2120) as a test instrument,six different batches of normal and non-normal 2 quality control were monitored continuously for one year,combined with 42 cases of fresh sample which were selected randomly,the author analyzed the precision,accuracy and comparability of the two instruments,and white blood cell(WBC),red blood cell (RBC),hemoglobin(HGB),hematocrit (HCT),mean corpuscular volume(MCV),mean corpuscular hemoglobin(MCH),mean corpuscular hemoglobin concentration(MCHC) and platelet(PLT) were chosen as the test indicators.Results The precision(CV％ values within a range of 0.9-5.0) of the two instruments were all within the CLIA'88 1/4 tolerance accepted range;All indicators' percentage difference between the two instruments are fit with the International Blood Standardization Committee(ICSH) Standard.The test results of 42 blood samples detected by different hematological analyzers were analyzed by regression analysis,which showed that the correlative coefficient (r) was over 0.97.Conclusion The method of continuously monitored the normal and non-normal 2 quality control for one year,combined with 42 cases of fresh sample which were selected randomly can well be used in the study of tests results comparability and consistency of two different hematological analyzers in Sports Biochemistry Laboratories.