3台血细胞分析仪的比对分析

目的：评价本科室3台血细胞分析仪检测结果的准确性和一致性。方法：使用重复性试验来检测3台仪器的精密度；使用比对试验来评价3台仪器检测项目（包括WBC、RBC、Hb、Hct和Pit）的准确性和一致性。根据美国临床实验室改进修正案（CLIA，88）标准（1／2）来判断测试仪器与参比仪器的相对偏差，是否符合判断标准。结果：3台仪器的精密度和稳定性均较好，其CV值均不大于5％：与LH750相比，Gens五分类和ACT-5diff的检测结果与其具有良好的相关性，相关系数γ均大于0．975；根据判断标准，2台测试仪器检测的RBC和Hct相对偏差均超出允许误差．WBC、Hb和Pit的相对偏差都在允许误差范围内。结论：在保证每台仪器的重复性和稳定性均良好的前提下，定期对仪器进行比对分析，能够及时发现仪器存在的系统误差，通过调整与校准可以确保检验科为临床回报出准确和一致的结果。

Verification Assessment in Three Hematology Analyzers

Objective To evaluate the veracity and consistency of the results obtained from three automated hematology analyzers. Methods The reproducibility tests were used to assess the precision, the verification tests were exerted to evaluate the accuracy and consistency of test parameters（WBC, RBC, Hb, Het and Plt） of the three hematology analyzers. According to the 1/2 standard of American Clinical Laboratory Improvement Amendment （CLIA, 88）, the relative bias of the reference analyzer and other assessed analyzers were determined. Results The results obtained from the three analyzers showed excellent precision and stability, the coefficients of variation （CV） were all less than 5%; compared with the results of LH750, the results of Gens 5diff and ACT-5diff showed excellent correlation, all coefficients of correlation（γ） exceeded 0.975. The results of both RBC and Hct obtained from Gens 5diff and ACT-Sdiff exceeded allowable error; the results of WBC, Hb and Ph were in the allowable error rangel Conclusion In the condition of the excellent precision and stability, system errors existed in the analyzer can be found by verification on time. Through being adjusted and calibrated, the hematology analyzers can meet the requirements and these results are consistent.