全自动血液分析系统检测有核红细胞和幼稚粒细胞的效能评价  

An Evaluation of the Performance of Automated Blood Analysis System forDetecting Nucleated Red Blood Cells and Immature Granulocyte

作　　者：李荣海[1] 宋北 董美衬 郑路青 陈勋[1] 郭盼[1] 李琦[1] 唐玉凤[1] LI Ronghai;SONG Bei;DONG Meichen;ZHENG Luqing;CHEN Xun;GUO Pan;LI Qi;TANG Yufeng(Department of Clinical Laboratory,Xiyuan Hospital,China Academy of ChineseMedical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院检验科,北京100091

出　　处：《标记免疫分析与临床》2024年第11期2073-2077,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家自然科学基金面上项目(编号:82074258,82274502)。

摘　　要：目的以人工显微镜检查法为标准,分析SYSMEX XN-9100全自动血液分析系统(XN-9100)检测有核红细胞(NRBC)和幼稚粒细胞的可靠性,用于指导血常规复检。方法收集采用XN-9100检测的NRBC>0个/100个白细胞(WBC)和/或幼稚粒细胞>0的血常规标本1465例,采用自动推染片机制片,人工显微镜法计数NRBC和幼稚粒细胞数量,以镜检法为金标准,评估仪器法计数NRBC和幼稚粒细胞的相关性和一致性,同时绘制受试者工作特征(ROC)曲线,评价XN-9100检测有核红细胞和幼稚粒细胞的诊断效能。结果仪器法与镜检法检测的NRBC数量和幼稚粒细胞数量均呈正相关(R^(2)分别为0.8631和0.7251)。Bland-Altman分析显示仪器法与镜检法计数NRBC比率差异的95%一致性界限范围为-0.59±10.75个/100 WBC,9例(0.61%)标本在一致性界限范围外,二者具有较好的一致性;仪器法与镜检法计数幼稚粒细胞百分率差异的95%一致性界限范围为(0.87±4.98)%,56例(3.82%)标本在一致性界限范围外,二者一致性较好。以人工镜检法计数的NRBC和幼稚粒细胞数量做为金标准绘制ROC曲线,曲线下面积分别为0.70和0.84。当设定仪器计数结果≥0.05个NRBC/100 WBC时,仪器的灵敏度(98.47%)和特异性(63.87%)最佳,假阴性1.53%,假阳性36.13%;当设定仪器计数幼稚粒细胞比率≥0.10%时,仪器的灵敏度(85.87%)和特异性(88.60%)最佳,假阴性14.13%,假阳性11.40%。结论XN-9100能快速检测出外周血中的NRBC和幼稚粒细胞数量,对有核红细胞检测的灵敏度较高但特异性相对较低,需镜检确认方可报告临床。对幼稚粒细胞检测的灵敏度、特异性均较高,但假阴性偏高,需结合散点图和报警信息综合判断是否需要复检,防止漏诊。Objective To analyze the reliability of SYSMEX XN-9100 automatic blood analysis system(XN-9100)for detecting nucleated red cells(NRBC)and immature granulocytes with manual microscopy as a standard and to further guide the re-examination of blood routine.Methods 1465 cases of NRBC>0/100 white blood cells(WBC)and/or immature granulocytes>0 were collected by XN-9100 tests.After smear staining,the number of NRBC and immature granulocytes was counted by artificial microscope.Microscopy was used as the gold standard to evaluate the correlation and consistency of NRBC and immature granulocytes counted by the instrument.Receiver operating characteristic(ROC)curve was plotted to evaluate the diagnostic efficacy of XN-9100 in detecting nucleated red cells and immature granulocytes.Results There was a positive correlation between the number of NRBC and the number of immature granulocytes detected by instrument and microscopy(R^(2)=0.8631 and 0.7251).Blan-Altman analysis showed that the 95%confidence interval of NRBC ratio difference between instrumental method and microscopic method was-0.59±10.75/100WBC,and 9 cases(0.61%)were outside the confidence interval,showing a good consistency.The 95%confidence interval of the difference between the percentage of immature granulocytes counted by instrument and microscopy was(0.87±4.98)%,and 56 cases(3.82%)were outside the agreement range.The number of NRBC and immature granulocytes counted by manual microscopy was used as the gold standard to draw the ROC curve,and the area under the curve was 0.70 and 0.84,respectively.The sensitivity(98.47%)and specificity(63.87%)of the instrument were the best when the counting result was≥0.05 NRBC/100WBC,with a false negative 1.53%and false positive 36.13%.The sensitivity(85.87%)and specificity(88.60%)were the best when the ratio of counting immature granulocytes was set at≥0.10%,with a false negative 14.13%and false positive 11.40%.Conclusion XN-9100 can rapidly detect the number of NRBC and immature granulocytes in peripheral blood,and h

关 键 词：有核红细胞 幼稚粒细胞 镜检规则 

分 类 号：R446.11[医药卫生—诊断学]