铜陵地区三级医疗机构某品牌血细胞分析仪结果比对和偏倚评估

Result comparison and bias evaluation of hematocyte analyzers in tertiary medical institutions of Tongling district

目的对铜陵地区三级医疗机构Sysmex公司生产的血细胞分析仪进行结果比对和偏倚评估,使检测结果可比、互通。方法参考美国临床和实验室标准化委员会EP9-A2文件的要求,试验采用患者新鲜全血样品在参考仪器(A)和测试仪器(B、C、D、E、F)对白细胞(WBC)、红细胞(RBC)、血红蛋白(Hb)、红细胞压积(HCT)、血小板计数(PLT)5项指标进行检测,制作散点图和偏倚图,计算回归方程、相关系数(r)、相对偏倚、预期偏倚和其95%的可信区间,评估结果之间的可比性。结果参考仪器和5套测试仪器的WBC、RBC、PLT、Hb和HCT 5项指标检测结果经F检验,差异无统计学意义(P>0.05);各参数测定结果之间相关性密切(r≥0.975),一致性良好;B、C、D、F仪器的相对偏倚和预期偏倚在允许范围内。测试仪器E的PLT低值结果相对偏倚(12.61%)超出美国临床实验室改进法案修正案质量要求的1/2EA(12.5%),但其预期偏倚可信区间的上限小于可接受偏倚,结果仍可为临床接受。结论实验室间相同品牌血细胞分析系统对新鲜抗凝全血的比对试验通过;检验人员应定期对检测结果进行比对和偏倚评估,保证同地区检测结果间的可比性和互通性。

Objective To ensure the consistency of test results by comparing the results on the determination and bias evaluation obtained from Sysmex hematocyte analyzers in tertiary medical institutions of Tongling District.Methods According to NCCLS（national committee for clinical laboratory standards）EP9-A2,fresh whole blood samples of patients were selected,using the reference instrument（A）and test instruments（B,C,D,E,F）to measure the white blood cell（WBC）,red blood cell（RBC）,platelet（PLT）,hematocrit（HCT）,hemoglobin（Hb）,scatter diagram and bias map were made,regression equations,the correlation coefficient（r）,relative bias,expected bias and 95%confidence interval were calculated,and the comparability of results were assessed.Results The five test results,WBC,RBC,PLT,Hb and HCT,by F test showed no significant differences（P〉0.05）using the reference instrument（A）and five test instruments（B,C,D,E,F）.Various parameters of the results between reference instrument and test instrument were closely related（r≥0.975）.The instruments of B,C,D,F relative bias and the expected bias within the permissible range.The relative bias of PLT low value in test instrument E（12.61%）beyond CLIA′88quality requirements of 1/2EA（12.5%）,but the expected bias upper limit of the confidence interval is less than acceptable results can bias,for clinical acceptance.Conclusion Analysis and comparison of fresh anticoagulant blood test by the same brand of hematocyte analyzers in laboratory.Inspection personnel should be regularly carried out comparison and bias evaluation on the test results,to ensure the detection results of the same area comparability and interoperability.