Sysmex XN-9000全自动血液体液分析仪性能评价

Performance Assessment of Sysmex XN-9000 Fully Automatic Blood and Body Fluid Analyzer

目的：对Sysmex XN-9000全自动血液体液分析仪的主要性能进行初步评价。方法根据美国临床和实验室标准化协会（CLSI）指南文件EP15-A2、EP6-A2的要求，对XN-9000仪进行精密度、携带污染率、线性范围和准确度验证，以Beckman LH750全自动血液分析仪的检测结果作为评估依据，将验证结果与厂商声明的性能指标或公认的质量标准进行比较。结果 XN-9000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%~2.42%，批间CV%为0.12%~2.50%，线性相关性分析r为0.99991~0.99999，携带污染率为0.00%~0.38%。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仪的精密度、携带污染率、线性范围和准确度等主要评估指标均符合要求。

Objective To evaluate the main performance of Sysmex XN-9000 fully-automatic blood and body fluid analyzer. Methods According to the guidelines EP15-A2 and EP6-A2 of clinical and laboratory standards institute （CLSI）, the precision, contamination rate, linearity range and accuracy of XN-9000 analyzer were verified based on the detection results of Beckman LH750 full-automatic blood analyzer which were choosed as assessment basis. Then the verification results of XN-9000 analyzer were compared with performance indicators declared by its manufacturer or recognized quality standards. Results The intra-assay and inter-assay coefficient variations （CV%） of major parameters including WBC, RBC, HGB, HCT and PLT measured by XN-9000 analyzer were 0.11%~2.42% and 0.12%~2.50%, respectively. The correlation coefficient （r ） of linear correlation analysis between observational values and theoretical values of the above parameters was 0.99991~0.99999 while the contamination rate of the above parameters was 0.00%~0.38%. The correlation coefficient （r ） of comparative correlation analysis between the detection indicators of XN-9000 analyzer and those of Backman LH750 analyzer was greater than 0.999. The Bias of accuracy verification of the above parameters of XN-9000 analyzer was -0.67%~0.96%. Conclusion The main parameters including precision, contamination rate, linearity range and accuracy of XN-9000 analyzer can meet the requirements of relevant standards.