SysmexXN-3000全自动血液分析仪性能评价

Performance evaluation of Sysmex XN- 3000 automated hematology analyzer

目的对Sysmex XN-3000全自动血液分析仪性能进行评价。方法依照行业标准对Sysmex XN-3000的本底计数、携带污染率、准确度、精密度、线性范围、可比性等指标进行评价,并以显微镜法为"金标准",评价其白细胞分类的准确性。结果 Sysmex XN-3000对全血细胞各项参数的本底计数均为0,携带污染率≤0.38%;除极低值水平PLT-I/O外,各种浓度水平患者全血样品或室内质控物的批内精密度、日间精密度均符合卫生行业标准,各参数线性范围相关系数均≥0.975,a≤1±0.05,符合CLSI文件和卫生行业标准要求。与Sysmex XE-1800相比,WBC、Ret、Hb、PLT参数线性相关系数≥0.975,a≤1±0.05;白细胞分类方面,与人工显微分类相比,中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞、嗜碱性粒细胞的相关系数分别为0.972、0.991、0.654、0.381、0.518,P<0.05。结论 Sysmex XN-3000具有携带污染率低、精密度高、线性范围宽的特点,并且同Sysmex XE-1800及人工显微镜分类计数具有很好的一致性,可用于临床大批量标本常规分析。

Objective To evaluate the performance of Sysmex XN- 3000 automated hematology analyzer. Methods According to the industry standard,the background count,carryover rate,accuracy,precision,linear range,comparability of Sysmex XN-3000 were evaluated,and with artificial microscopy as the gold standard,its classification accuracy on leukocyte was evaluated.Results The background counts for complete blood parameters were all 0 with Sysmex XN- 3000,the carry- over contamination rate was ≤0. 38%. In addition to the extreme low levels of PLT- I / O,various levels of patients＇ whole blood samples or indoor quality control in each batch and the daytime precision all met the requirements of industry hygiene standard; the linear correlation coefficient of the parameters were all ≥0. 975,a≤1 ± 0. 05,which met the requirements of the CLSI document and the industry hygiene standards. Compared with Sysmex XE- 1800,the correlation coefficient of WBC,Ret,Hb,PLT were ≥0. 975,a≤1 ± 0. 05. Compared with artificial microscopy leukocyte classification,the correlation coefficient of neutrophils,lymphocytes,monocytes,eosinophils and basophils were respectively 0. 972,0. 972,0. 654,0. 381,0. 518,P〈0. 05. Conclusion Sysmex XN- 3000 has the characteristics of low carry- over rate,high precision,wide linear range,and is consistent with Sysmex XE- 1800 and artificial microscope in leukocyte classification. It could be used for routine analysis of a large quantities of clinical specimens.