同一医院内不同血细胞分析系统检测结果可比性验证

Comparability verification of detection results of different blood cell analysis systems in same hospital

目的评估同一医院不同血细胞分析系统检验结果的可比性。方法参照《医疗机构内定量检测结果的可比性验证指南》建立可比性验证方案,用适合浓度的患者新鲜EDTA-K2抗凝全血在4台血细胞分析仪Sysmex XT-1800i、Sysmex XT-2000i、Sysmex XT-4000i、迈瑞BC-5800上检测HGB、RBC、HCT、PLT、WBC等5项参数,计算其极差,并进行检测结果一致性分析。结果临界差值可接受标准定为HGB3.5%、RBC3%、HCT3%、PLT12.5%、WBC 7.5%。各比对样本的重复检测次数最少2次,最多5次。重复检测比对样本后得出4套检测系统HGB、RBC、HCT、PLT、WBC的3个浓度水平极差范围分别为2.87%～6.29%、1.57%～2.99%、1.95%～4.77%、12.81%～25.74%、6.72%～11.13%。RBC在4套检测系统的检测结果极差均小于临界差值,验证通过。HGB、HCT、PLT、WBC在4套检测系统的检测结果极差均有大于临界差值的情况,验证未通过。剔除有明显偏倚的检测系统后,其余检测系统检测结果验证通过。结论 4套检测系统对RBC的检测结果具有可比性,Sysmex XT-1800i、Sysmex XT-2000i、Sysmex XT-4000i对HGB、HCT、PLT的检测结果具有可比性,Sysmex XT-1800i、Sysmex XT-2000i、迈瑞BC-5800对WBC的检测结果具有可比性。

Objective To evaluate the comparability of the detection results of different blood cells analysis systems in same hospital.Methods Referring to the Guideline for Comparability Verification of Quantitative Test Results in Medical Institutions,the comparability validation protocol was established.The EDTA-K2 anticoagulation fresh whole blood samples with proper concentration were detected for 5parameters of HGB,RBC,HCT,PLT and WBC by 4systems（Sysmex XT-1800 i,Sysmex XT-2000,Sysmex XT-4000 iand Mindray BC-5800）.The range was calculated and the detection results consistency analysis was performed.Results The acceptable standard of critical differentials was intended to be HGB3.5%,RBC3%,HCT3%,PLT12.5% and WBC7.5%.The replication detection was at least 2times and up to 5times.The ranges of 3concentrations after replication detection and sample comparison were 2.87%-6.29%,1.57%-2.99%,1.95%-4.77%,12.81%-25.74%and 6.72%-11.13%respectively.The ranges of RBC detection results in 4systems were smaller than the critical differentials,the validation was passed.The ranges of HGB,HCT,PLT and WBC detection results in 4systems all had the condition of more than the critical differentials,the validation did not passed.After removing the test system with obvious bias,the validation of the detection results by other test systems was passed.Conclusion The RBC detection results by 4systems have the comparability;the HGB,HCT and PLT detection results by Sysmex XT-1800 i,Sysmex XT-2000 iand Sysmex XT-4000 ihave the comparability;the WBC detection results by Sysmex XT-1800 i,Sysmex XT-2000 iand Mindray BC-5800 have the comparability.