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

Performance verification and interference factors of SYSMEX XN-9000 hematology analyzer for the determinations of reticulocyte count and parameters according to CAP accreditation requirements

目的评价SYSMEX XN-9000血液分析仪检测网织红细胞(RET)及其特异性参数的性能,进一步加强临床对贫血疾病的诊断和治疗。方法收集508例患者标本,采用新亚甲蓝(NMB)染色显微镜目视计数法与SYSMEX XN-9000血液分析仪的RET计数进行方法学比对和不同干扰因素分组研究;根据美国临床实验室标准化协会(CLSI)-国际血液学标准化委员会(ICSH)H44-A2文件要求对SYSMEX XN-9000血液分析仪计数RET的精密度、携带污染率、可比性、准确度、干扰因素等进行验证;采用直线回归和配对t检验进行相关性统计,用Bland-Altman检验进行一致性检验,采用t检验或Wilcoxon秩和检验对干扰因素进行分析。结果目视计数法与仪器法r^2=0.97,一致性符合率为91.7%;精密度、携带污染率、准确度、稳定性均在允许范围内,线性范围和正常参考区间均符合验证;红细胞、血小板增多,红细胞碎片、有核红细胞等干扰因素的存在均能导致网织红细胞计数百分比(RET%)结果的假性增高,荧光类药物和疟原虫等影响因素对RET结果会产生严重干扰。结论 SYSMEX XN-9000血液分析仪对RET及其参数的检测性能良好,但在临床应用中仍需及时发现和纠正可能存在的干扰。

Objective To assess the performance of reticulocyte （RET） determination and its specificparameters by SYSMEX XN-9000 hematology analyzer,and to improve the diagnosis and treatment of anemia.Methods A total of 508 specimens were collected. New methylene blue （NMB） visual microscopy methodand SYSMEX XN-9000 for the determination of RET count were compared,and the interference factors wereanalyzed. The precision,carry-over rate,comparability,accuracy and interference factors of RET determinationby SYSMEX XN-9000 were evaluated according to the Clinical and Laboratory Standards Institute （CLSI）-theInternational Council for Standardization in Haematology （ICSH）document H44-A2. The correlation analysiswas performed by linear regression analysis and paired t test. The consistency test was performed by Bland-Altmantest,and the interference factors were assessed by t test or Wilcoxon rank sum test. Results The coefficientof determination （r2） between NMB visual microscopy method and SYSMEX XN-9000 was 0.97,and theconsistency rate was 91.7%. The precision,carry-over rate,accuracy and stability were within allowable ranges.Linear range and normal reference interval met the requirements of verification. The main sources of spuriously highRET counts were erythrocytosis,thrombocytosis,erythrocyte fragments and nucleated erythrocytes,especiallyautofluorescence due to drugs and malaria. Conclusions SYSMEX XN-9000 for the determination of RET count has good performance. Potential interference may exist,which should be corrected in time.