Abstract:Objective To verify and evaluate the performance of SysmexXN9000 automatic hematology analyzer with two analysis modules. Methods According to “Health Standard of the People′s Republic of China WS/T406-2012”, performance of SysmexXN9000 (A1+B4) automatic blood analyzer for complete blood count, leukocyte classification, reticulocyte count, etc was verification and evaluated. Results Blank counting, carrying contamination rate, precision (within and between batches), accuracy and linearity all meet the standard requirements. Leukocyte classification and reticulocyte were correlated with manual count (P < 0.01), and the correlation coefficients of A1 and B4 modules were 0.675 and 0.678, respectively, which were smaller than other parameters. Conclusion The SysmexXN9000 (A1+B4) automatic blood analyzer has good performance and high clinical value.
[1] International Council for Standardization in Haematology,Writing Group,BRIGGS C,et al. ICSH guidelines for the evaluation of blood cell analysers including those used for differential leucocyte and reticulocyte counting [J]. Int J Lab Hematol,2014,36(6):613-627.
[2] 廖红艳,陈姣,毛志刚,等.XN-9000血液分析流水线智能化管理系统的建立及其应用[J].临床检验杂志,2016, 34(5):394-397.
[3] 中国合格评定国家认可委员会.CNAS-CL02:2012医学实验室质量和能力认可准则[S].北京:中国计量出版社,2013.
[4] 中国合格评定国家认可委员会.CNAS-CL43:2012医学实验室质量和能力认可准则在临床血液学检验领域的应用说明[S].北京:中国计量出版社,2012.
[5] Laura S,Sandra S,Andrea P,et al. External quality assessment programs in the context of ISO 15189 accreditation [J]. Clin Chem Lab Med,2018,56(10):1644-1654.
[6] 卫生部临床检验标准专业委员会.WS/T406-2012临床血液学常规检测项目分析质量要求[S].北京:中国标准出版社,2012.
[7] 卫生部临床检验标准专业委员会.WS/T246-2005白细胞分类计数参考方法[S].北京:中国标准出版社,2005.
[8] 尚红,王毓三,申子瑜.全国临床检验操作规程[M].4版.北京:人民卫生出版社,2015:3-5.
[9] 王科文.大型流水线血液分析仪XN9000的搬迁和安装[J].医疗装备,2015,28(9):116-117.
[10] Schapkaitz E,Raburabu S. Performance evaluation of the new measurement channels on the automated Sysmex XN-9000 hematology analyzer [J]. Clin biochem,2018, 53:132-138.
[11] Vis JY,Huisman A. Verification and quality control of routine hematology analyzers [J]. Int J Lab Hematol,2016,38(1):100-109.
[12] 熊仲波,金孝燕,陆波,等.Sysmex XN-9000全自动血细胞分析仪性能评价[J].国际检验医学杂志,2015(10):1373-1375.
[13] Jo SY,Park SH,Kim IS,et al. Performance evaluation of recently launched Sysmex XN-550 Automatic Hematology Analyzer [J]. Int J Lab Hematol,2017,39(1):e4-e9.
[14] Hegde RB,Prasad K,Hebbar H,et al. Development of a Robust Algorithm for Detection of Nuclei and Classification of White Blood Cells in Peripheral Blood Smear Images [J]. J Med Syst,2018,42(6):110.
[15] Ciepiela O,Kotu?覥a I,Kierat S,et al. A comparison of Mindray BC-6800,Sysmex XN-2000,and Beckman Coulter LH750 automated hematology analyzers:a pediatric study [J]. Clin Lab Anal,2016,30(6):1128-1134.
[16] 任朝翔,吴茅,俞雅瑶,等.XE-2100血液分析仪计数嗜碱性粒细胞假性增高原因分析[J].医学理论与实践,2014,27(22):3057-3058.
[17] 谢婧雯,姜函,陈琼,等.Excel工具表对仪器白细胞分类及复检规则进行验证[J].检验医学与临床,2018,15(10):102-104.
[18] 伍文静,陈倩礼,张玲,等.Sysmex XN-1000(B3)全自动血液分析仪性能验证及未成熟粒细胞报警信息可信度的评价[J].检验医学与临床,2016,13(z2):35-38.
[19] Kim AH,Lee W,Kim M,et al. White blood cell differential counts in severely leukopenic samples:a comparative analysis of different solutions available in modern laboratory hematology [J]. Blood Res,2014,49(2):120-126.
[20] 彭碧,马永能,何芳,等.网织红细胞相关参数在珠蛋白生成障碍性贫血和缺铁性贫血中的诊断价值[J].国际检验医学杂志,2018,39(2):153-155.
[21] Piva E,Brugnara C,Spolaore F,et al. Clinical Utility of Reticulocyte Parameters [J]. Clin Lab Med,2015,35(1):133-163.
[22] Lim YK,Chi HY,Lee MK,et al. Necessity of Reticulocyte Calibration for More Accurate and Precise Results [J]. Ann Lab Med,2018,38(4):375-377.
[23] Grillone R,Grimaldi E,Scopacasa F,et al. Evaluation of the reticulocyte counting by the Mindray BC 6800 automated hematology analyzer:comparison with ABX Pentra 120,Coulter LH 750,and microscopy [J]. Int J Lab Hematol,2015,37(1):e3-e6.
[24] 蒋浩琴,顾剑飞,陈健,等.CAP认可要求下SYSMEX XN-9000血液分析仪测定网织红细胞及其参数的性能验证与干扰因素研究[J].检验医学,2018,33(5):59-64.