XN-9000多功能自动血液分析仪性能评价

目的：对Sysmex公司最新推出的Sysmex XN-9000多功能自动血液分析仪的主要性能进行初步评价，以证实其检测效果。方法按美国临床实验室标准化协会指南文件EP15-A2、EP6-A2的要求对Sysmex XN-9000血液分析仪进行精密度、携带污染率、线性范围和正确度进行验证，以Backman LH750比对结果作为评估依据，结果与厂商声明的性能或公认的质量标准进行比较。结果 XN-9000血液分析仪测定白细胞（WBC）、红细胞（RBC）、血红蛋白（HGB）、红细胞压积（HCT）和血小板（PLT）主要参数的批内变异系数（CV%）为0.11%-2.32%，批间CV%为0.12%-2.46%，线性相关性分析r为0.99990-0.99997，携带污染率为0-0.37%，对比相关性分析，各项指标r均〉0.999，准确度验证各项指标的偏倚为-0.67-0.96。结论 XN-9000仪测定主要参数的精密度、线性、携带污染率、准确性等主要评估指标均符合要求，检测结果可用于临床。

Performance evaluation of XN-9000 multi-function automatic blood analyzer

Objective To carry on a preliminary performance evaluation of Sysmex XN-9000 multi-func-tion automatic blood nalyzer, to confirm its test performance. Methods According to the EP15-A2 and EP6-A2 re-quirements of American association of clinical laboratory standardization guidelines, Sysmex XN-9000 blood analyzer＇s precision, carry-over, linear range and accuracy were confirmed. Taking Backman LH750 as basis for evaluating, the re-sults were compared with the manufacturer＇s performance statement or recognized quality standards. Results The coef-ficient of variation （CV%） within-run of XN-9000 blood analyzer determination of white blood cell （WBC）, red blood cell （RBC）, hemoglobin （HGB）, hematocrit （HCT） and platelet （PLT） was 0.11%-2.32%, the between-run CV%was 0.12%-2.46%, linear correlation r was 0.999 90-0.999 97, the carry-over was 0-0.37%, the correlation analysis of each index r〉0.999, the indicators accuracy verification bias was-0.67-0.96. Conclusion XN-9000 instrument for determination of main parameters of precision, accuracy, linear, carry-over and other major evaluation indexes meet the requirements and is therefore useful for clinical application.