Abstract：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.
施俊柱. Sysmex XN-9000全自动血液体液分析仪性能评价[J]. 中国医疗设备, 2014, 29(11): 131-133.
SHI Jun-zhu. Performance Assessment of Sysmex XN-9000 Fully Automatic Blood and Body Fluid Analyzer. China Medical Devices, 2014, 29(11): 131-133.
