摘要
目的建立新鲜血比对方案,完善血液分析仪日常室内质量控制(IQC),保证临床标本检测结果的可比性和一致性。方法每日采用血液分析仪配套质控品完成IQC后,抽取检测结果在参考区间内,且血量约为2 mL的新鲜血标本。选择性能良好的血液分析仪作为靶机,以其他血液分析仪为比对仪器。以新鲜血标本在靶机中测定的结果作为靶值,比对仪器的测定结果作为测定值,比较靶值和测定值的差异,计算白细胞(WBC)计数、红细胞(RBC)计数、血红蛋白(Hb)、血细胞比容(HCT)、血小板(PLT)计数项目的相对偏差。仪器间相对偏差标准为1988年美国临床实验室改进法案(CLIA'88)允许误差的1/2,血液分析仪运行过程中的相对偏差标准为CLIA'88允许误差的1/3。根据偏差标准对相对偏差进行评价。结果比对仪器与靶机的相对偏差符合1/2 CLIA'88允许误差的偏差范围的要求,仪器间检测结果具有可比性;血液分析仪运行过程比对数据的相对偏差符合1/3 CLIA'88允许误差的偏差范围的要求。结论建立的新鲜血比对方案既能保证血液分析仪间检测结果的可比性和仪器运行过程中的稳定性,又能对血液分析仪进行方便、经济、有效的日常IQC。
Objective To establish a fresh blood comparison program so as to ensure the comparable and consistent results of clinical specimens,and to improve the daily internal quality control(IQC)of hematology analyzers.Methods After the completion of daily IQC with supporting quality control products,2 mL fresh blood sample was drawn with test results within reference ranges.A hematology analyzer with good performance was selected as the target,and the remaining instruments were used as comparison instruments.The results tested by the target instrument were used as the target values,while the results tested by the comparison instruments were used as the measured values.Comparing the target values and the measured values,the relative deviations of white blood cell(WBC),red blood cell(RBC),hemoglobin(Hb),hematocrit(HCT)and platelet(PLT)were calculated.The 1/2 of allowable error in the Clinical Laboratory Improvement Amendments of 1988(CLIA'88)was the relative deviation standard between different instruments,while the 1/3 of allowable error was the relative deviation standard of the same hematology analyzer at different times.The relative deviation was evaluated according to the relative deviation standard.Results The relative deviations of the comparison data among the comparison instruments and the reference instrument met the requirements of 1/2 CLIA'88 deviation range,showing the accurate and comparable determination results among the instruments.The relative deviations of the comparison data during the operation of the whole cell analyzers met the requirements of the 1/3 CLIA'88 deviation range,indicating the stable instruments.Conclusions The fresh blood comparison program could not only ensure the comparability of determination results among hematology analyzers and the stability of the same instrument during operation,but also perform convenient,economical and effective IQC on the hematology analyzers.
作者
郑翠玲
王力
程焱
崔巍
ZHENG Cuiling;WANG Li;CHENG Yan;CUI Wei(Department of Clinical Laboratory,the National Cancer Center,the National Clinical Research Center for Cancer,Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)
出处
《检验医学》
CAS
2021年第6期662-666,共5页
Laboratory Medicine
基金
国家科技重大专项项目(2018ZX10302-205)
中国医学科学院肿瘤医院教学研究课题(E2019D07)。
关键词
血液分析仪
新鲜血
比对方案
室内质量控制
Hematology analyzer
Fresh blood
Comparison program
Internal quality control
