外周血有核红细胞项目的性能验证及临床意义探讨  

The Performance Verification and Clinical Significance of the Peripheral Blood Nucleated Red Blood Cell Project

作　　者：程瑜 先洁 黄佳佳 李月[1] CHENG Yu;XIAN Jie;HUANG Jiajia;LI Yue(Department of Laboratory Medicine,the Second Affiliated Hospital of Chongqing Medical University,Chongqing,400010 China;Department of Pathology,the First Affiliated Hospital of Chongqing Medical University,Chongqing,400016 China)

机构地区：[1]重庆医科大学附属第二医院检验科,重庆400010 [2]重庆医科大学附属第一医院病理科,重庆400016

出　　处：《系统医学》2021年第22期45-48,52,共5页Systems Medicine

摘　　要：目的对SYSMEX XN-3000全自动血细胞分析仪外周血有核红细胞(nucleated red blood cell,NRBC)项目的分析性能进行验证并探讨外周血有核红细胞的临床意义。方法参考WS/T 406-2012《临床血液学检验常规项目分析质量要求》对XN-3000全自动血细胞分析仪检测外周血NRBC项目的批内精密度、批间精密度、携带污染率和线性范围进行全面评价。对NRBC阳性患者,结合白细胞数量检测,评价患者NRBC百分率(NRBC%)与病死率的关系(排除血液系统疾病患者)。对死亡组和好转组的多次检测结果进行趋势性分析。结果XN-3000全自动血细胞分析仪检测外周血NRBC的性能验证结果:携带污染率为0.12%;批内精密度(低、中、高值)变异系数分别为6.11%、3.35%、0.88%;批间精密度(低、中、高值)变异系数分别为5.34%、3.54%、1.43%;线性范围验证回归曲线Y=0.9979X+0.5194,r^(2)=0.9976。以上性能指标均达到SYSMEX厂家说明书的标准。外周血NRBC水平增高预示患者预后不良、死亡风险增大,对临床及早发现不良预后具有一定的指导意义。结论该研究基于SYSMEX XN-3000仪器对外周血有核红细胞检测性能进行验证,结果显示其性能满足厂商声明的要求和基于生物学变异的允许范围,保证后续临床试验检测患者标本的准确性和可靠性,同时其验证方案可为其他实验室开展性能验证提供参考。外周血NRBC计数与多种疾病有关,外周血NRBC计数对患者预后的早期判断具有一定的指导意义。Objective To verify the analytical performance of the peripheral blood nucleus red blood cell(NRBC)project of SYSMEX XN-3000 automatic blood cell analyzer and to explore the clinical significance of peripheral blood nucleated red blood cells.Methods According to WS/T 406-2012"Quality Requirements for Routine Analysis of Clinical Hematology Test",the intra-batch precision,inter-batch precision,contamination carrying rate and linear range of XN-3000 automatic hematology analyzer testing NRBC in peripheral blood were comprehensively evaluated.In NRBC-positive patients,the relationship between NRBC percentage(NRBC%)and mortality was evaluated in combination with WBC count(excluding patients with hematological diseases).Trend analysis was performed for multiple tests in the death group and the improvement group.Results The performance verification result of the XN-3000 automatic blood cell analyzer for detecting peripheral blood NRBC:the contamination rate was 0.12%.The coefficient of variation of the intra-assay precision(low,medium,and high value)were 6.11%,3.35%,and 0.88%,respectively.The coefficients of variation of the inter-assay precision(low,medium,and high values)were 5.34%,3.54%,and 1.43%,respectively.Linear range verification regression curve Y=0.9979X+0.5194,r^(2)=0.9976.The above performance indicators have reached the standard of the SYSMEX manufacturer's manual.Increased levels of NRBC in peripheral blood indicate a poor prognosis and an increased risk of death in patients,and have certain guiding significance for early detection of poor prognosis in clinical practice.Conclusion This research is based on the SYSMEX XN-3000 instrument to verify the detection performance of peripheral blood nucleated red blood cells.The results show that its performance meets the requirements declared by the manufacturer and the allowable range based on biological variation.It ensures the accuracy and reliability of subsequent clinical experiments to detect patient specimens,and its verification program can provide a refe

关 键 词：SYSMEX XN-3000 性能验证 血细胞分析仪 外周血有核红细胞 预后评估 

分 类 号：R446.113[医药卫生—诊断学]