医疗机构内不同血细胞分析仪的结果比对与溯源性评价

Result comparison and traceability evaluation of medical institutions of different hematocyte analyzer

目的对某医院内不同血细胞分析仪进行结果比对和室内质量控制,探讨结果可比性和溯源性。方法按照美国实验室标准化委员会(NCCLS)EP9-A2文件要求,以多次取得全国质控优秀成绩的XT-2000i血细胞分析仪为参考仪器,XT-1800i血细胞分析仪和MEK-6318K血细胞分析仪为测试仪器,每天随机选取高、中、低值患者标本8例,共分析5 d,来评价白细胞(WBC)、红细胞(RBC)、血小板(PLT)、血红蛋白(HGB)、红细胞比积(HCT)的结果,计算回归方程和相关系数,评估结果之间的可比性。结果3种仪器检测的WBC、RBC、PLT、HGB和HCT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;偏差在允许范围内。结论实验室使用两个以上检测系统检测同一项目时,应每天进行室内质量控制,定期进行不同检测系统间结果比对和溯源性评估,对结果偏差进行校正,确保结果的准确性。

Objective To investigate the comparability and traceability of results by comparing the results and internal quality con-trol analysis obtained from the different hematocyte analyzers in the hospital.Methods According to NCCLS(National Committee for Clinical Laboratory Standards)EP9-A2,with XT-2000i hematocyte analyzer,which repeatedly achieved excellent results in external quality assessment as reference instrument,XT-1 800i hematocyte analyzer and MEK-631 8K hematocyte analyzer as test instrument,eight species with high,medi-um and low value were selected daily at random,and the hematocyte analyzers were used to measure the white blood cell(WBC),red blood cell(RBC),platelet(PLT),hemoglobin(HGB),and hematocrit(HCT)for five days.The results were recorded,regression equations were cre-ated,the correlation coefficient (r)was calculated,and comparability between the results were evaluated.Results There were no statistical differences via F test in test results of WBC,RBC,PLT,HGB and HCT among the three detection systems(P>0.05).Various parameters of the results between reference instrument and test instrument were closely related (r≥0.975)with good consistency.The deviations were with-in the allowable range.Conclusion When two or more laboratory detection systems using the same project were performed,daily internal quality control should be carried out ,regular results among different detection systems should be compared ,the traceability should be assessed,and the results of bias should be corrected to ensure the accuracy of the results.