多台全自动血液分析仪检验结果的可比性验证

The comparability verification for the results of different automated hematology analyzers

目的对实验室内多台血液分析仪检测白细胞(WBC)、红细胞(RBC)、血小板(PLT)等项目的检测结果进行比对分析,评估同一实验室内不同型号血液分析仪测定结果的一致性,为临床提供准确、可信的检验结果。方法依照《医疗机构定量检验结果的可比性验证指南》要求,选取样本分别在不同血液分析仪上进行WBC、PLT、RBC、血红蛋白(Hb)、RBC压积(HCT)、平均RBC体积(MCV)、平均RBC Hb含量(MCH)和平均RBC Hb浓度(MCHC)检测,并计算比对偏差(R)。以美国临床实验室改进修正法案CLIA'88的1/3允许总误差(TEa)为判断标准,判断仪器间的可比性。结果各项检测指标在多台血液分析仪的R均<1/3 CLIA'88TEa要求,均在临床可接受范围内。结论通过应用不同检测系统检测WBC、PLT、RBC、Hb、HCT、MCV、MCH、MCHC的结果并计算R,可确保检测结果的一致性和可比性,满足临床要求。

Objective To analyze comparatively for white blood cell（WBC）,red blood cell（RBC） and platelet（PLT） results of different automated hematology analyzers,to evaluate the consistency,in order to provide reliable results for clinic.Methods According to THE Guideline for Comparability Verification of Quantitative Results within One Health Care System,the WBC,PLT,RBC,HGB,HCT,MCV,MCH and MCHC were detected by different automated hematology analyzers,and their relative bias（R） was calculated.As the standard of 1 /3 allowed total error（TEa） of Clinical Laboratory Improvement Amendments（CLIA） ＇88,the comparability among different analyzers was analyzed.Results The R of WBC,PLT,RBC,HGB,HCT,MCV,MCH and MCHC by different automated hematology analyzers were 1 /3 CLIA＇88 TEa,which were all acceptable.Conclusions The results of WBC,PLT,RBC,HGB,HCT,MCV,MCH and MCHC by different analyzers have good consistency and comparability which is suitable for clinic.