三种血细胞分析仪检测结果可比性研究

目的探讨三种不同品牌型号血细胞分析仪检测结果之间的可比性,为实现区域内检测结果的一致性提供依据。方法在对血细胞分析仪完成精密度检测后,依据美国临床实验室标准协会(CLSI)批准文件EP9-A2所列标准,以XT-1800i系统为基准系统,对CD-1800和BC3000plus所得数据进行比对与系统偏差评估。结果三种血细胞分析仪测定数据显示其批内精密度符合美国临床实验室改进修正法案(CLIA’88)允许范围,三种仪器测定数据间系统偏差不具备统计学显著性,均符合临床报告要求。结论三台血细胞分析仪检测结果可比性良好,符合临床诊疗要求。

COMPARATIVE ANALYSIS ON THE RESULTS OF THREE TYPES OF BLOOD CELL ANA- LYZER

Objective To evaluate the comparability between three different types of hematology analyzer test results, and provide the experimental data for the consistency of test results in the region. Methods After completed the precision detection test of three types of hematology analyzer, according to the American Society of Clinical Labo- ratory Standards Institute （CLSI） approved document EP9 -A2 criteria listed, XT - 1800i as a reference system for the CD -1800 and BC3000plus for obtained data, the comparison and system deviation assessment were carried out. Results Three types of hematology analyzer data showed that the within - run precisions were intra - compliance with the allowable range by the American Society of Clinical Laboratory Improvement Amendment Act （CLIA＇88） , and it also showed the system deviation does not have statistically significant. They are conforming to the clinical reporting requirements. Conclusion Three types of hematology analyzer have the comparability of test results, in line with the requirements of clinical diagnosis and treatment.