SYSMEX XN-550全自动血液分析仪的校准及性能评价

Calibration and performance evaluation of the SYSMEX XN-550 fully automatic blood analyzer

目的对SYSMEX XN-550全自动血液分析仪检测系统进行校准及性能评价.方法按照WS/T 347-2011《血细胞分析的校准指南》及WS/T 406-2012《临床血液学检验常规项目的分析质量要求》,对血细胞分析仪XN-550进行校准及性能评价,即对血细胞分析中白细胞(WBC)、红细胞(RBC)、血红蛋白(HB)、平均红细胞体积(MCV)、平均红细胞血红蛋白浓度(MCHC)、红细胞压积(HCT)、血小板(PLT)等7个主要检测项目进行本底计数、携带污染率、批内精密度、日间精密度、线性、正确度、不同吸样模式的结果可比性、实验室内结果可比性、准确度、仪器五分类比对及人员与仪器间白细胞分类计数的比较(人机五分类)等性能进行检测.结果SYSMEX XN-550全自动血液分析仪校准合格,在规定校准时效内可进行相关检测.其性能测试包括本底计数、携带污染率、批内精密度、日间精密度、线性、正确度、不同吸样模式的结果可比性、实验室内结果可比性、准确度、仪器间五分类比对、人机五分类实验等检测均通过验证.结论SYSMEX XN-550全自动血液分析仪校准合格,各分析性能良好,达到了临床血液实验室要求,且满足ISO 15189现场评审要求.

Objective To calibrate and evaluate the performance of SYSMEX XN-550 automated hematology analyzer.Methods According to WS/T 347-2011 calibration guidelines for blood cell analysis and WS/T 406-2012 analysis quality requirements for routine items of clinical hematology testing,the automated hematology analyzer XN-550 was calibrated and the performance of the instrument was evaluated.The seven major evaluated items included WBC,RBC,HB,MCV,MCHC,HCT and PLT.And we evaluated these items in background count,carryover rate,between-run precision,inter-day precision,linear range,accuracy,precision,the comparability of different sample absorption mode,and the comparison of five classification between instrument and manual-counting.Results SYSMEX XN-550 automatic hematology analyzer was qualified for calibration,and relevant tests could be carried out within the prescribed calibration time.Its performance tests include background count,carryover rate,between-run precision,inter-day precision,linear range,accuracy,precision,the comparability of different sample absorption mode,and the comparison of five classification between instrument and manual-counting,and these tests all passed validation.Conclusion The SYSMEX XN-550 automatic hematology analyzer is qualified for calibration and has good analytical performance.It meets the requirements of clinical blood laboratory and meeting the requirements of IS015189 on-site review.