摘要
目的评价分析血细胞分析流水线中各模块的工作性能,建立出模块化血液分析系统中的参考仪器,确保检验结果的准确性和可比性。方法分别对该实验室使用的模块化血液分析系统XN-9000血细胞分析流水线中的6个模块进行校准,校准各项指标均通过后,分别对6个模块的本底测试、携带污染率、批内精密度、批间精密度、准确度、不确定度、线性、可报告范围、实验室内部比对等方面进行综合性能评估,从6个模块中选择综合性能最好的模块为本实验室的参考仪器(即靶仪器)。结果6个模块的本底测试均满足要求,通过横向比较,在6个模块中模块1和模块6的携带污染率比较小;批内精密度模块6最好,其次为模块2;日间精密度模块2最好,其次为模块6;准确度以模块6最优其次为模块3。6个模块血液常规检验直接测量项目[白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白(Hb)、血小板计数(PLT)]不确定度结果较理想,通过综合的比较模块2较优其次为模块6;6个模块的比对结果偏移最小的为模块2,其次为模块6;线性和可报告范围验证结果均符合相关规定的要求[a值在(1.00±0.05)范围内,相关系数r≥0.975]。结论通过横向和纵向的综合比较分析,在6个模块中模块6的工作性能最优,最终选择模块6当做该实验室的参考仪器(靶机),用于ISO15189认可、等级医院评审、室间质评上报等日常工作当中。
Objective To evaluate and analyze the performance of each module in the blood cell analysis pipeline,and establish the reference instrument in the modular blood analysis system to ensure the accuracy and comparability of the test results.Methods Calibrated the six modules of the modular blood analysis system of XN-9000 blood cell analysis line respectively.After all the calibration indexes were passed,we investigated the background test,residual contamination rate,inner-group precision,inter-group precision,accuracy,uncertainty,linearity range,reportable range and intra-laboratory comparison of the six modules and choose the best comprehensive performance module as the reference instrument(target instrument).Results The background tests of the six modules all met the requirements.Through horizontal comparison,the residual contamination rate of module 1 and module 6 was relatively small;the inner-group precision of module 6 was the best,followed by module 2;the in-day precision of module 2 was the best,followed by module 6;the accuracy of module 6 is the best,followed by module 3.The results of uncertainty of the direct measurement items for routine blood tests(WBC,RBC,Hb,PLT)in six modules were ideal,the module 2 was the best and the second one was the module 6 by comprehensive comparison.The smallest deviation of the six modules is module 2,followed by module 6,both the linearity and reportable range were met the requirements of relevant regulations[a value was in the range of(1.00±0.05),the coefficient of correlation r≥0.975].Conclusion The working performance of module 6 was the best among the six modules by horizontal and vertical comparison.Finally,we choose the module 6 as the reference instrument(target instrument),which is used for ISO15189 accreditation,grade hospital accreditation,external quality assessment and other daily works.
作者
韩启福
曾园红
聂静
李子安
彭海
阿祥仁
HAN Qifu;ZENG Yuanhong;NIE Jing;LI Zian;PENG Hai;A Xiangren(Department of Medical Inspection,People′s Hospital of Qinghai Province,Xining,Qinghai 810007,China)
出处
《国际检验医学杂志》
CAS
2019年第24期3022-3027,3032,共7页
International Journal of Laboratory Medicine
关键词
分析系统
工作性能
参考仪器
analysis system
working performance
reference instruments