XN-9000全自动血液分析流水线复检规则的建立与验证  

Establishment and Validation of Sysmex XN-9000 Hematology Analyzer Review Criteria

作　　者：杨佳彧 王川 李勇[1] 夏永辉[1] YANG Jia-yu;WANG Chuan;LI Yong;XIA Yong-hui(Department of Clinical Laboratory,Institute of Hematology,Chinese Academy of Medical Science and Peking Union Medical College,Tianjin,300020,China)

机构地区：[1]中国医学科学院北京协和医学院血液学研究所血液病医院临床检测中心,天津300020

出　　处：《中国血液流变学杂志》2018年第2期203-208,共6页Chinese Journal of Hemorheology

摘　　要：目的通过日本希森美康公司的XN-9000血液分析流水线,对患者的外周血进行血细胞分析,参考国际血液学复检专家组建议的41条规则与国内专家提出的27条复检规则,制定适合中国医学科学院血液病医院临床检验室住院患者外周血的血细胞分析复检规则。方法随机收取采用Sysmex XN-9000全自动血细胞分析流水线检测的该院住院患者标本484例,制备血涂片进行镜下检查,对自行拟定的初版复检规则的性能进行评估,计算真阳性、假阳性、假阴性、真阴性和复检率等参数,并结合实际情况修改复检规则,最终制定出适合该院的复检规则,并采用360例标本进行验证。结果将显微镜镜下检查的结果用作衡量性能的金标准,使用初步拟定的复检规则进行分析假阳性率为3.72%,假阴性率为6.40%,阳性预测值为91.82%,阴性预测值为88.26%,复检率45.45%。因漏检率不合标准,且复检率较高。因此通过与金标准分析比对并结合仪器性能,对该规则进行修改,并另收取360例标本用于验证新规则,其中假阳性率为1.94%,假阴性率为3.06%,阳性预测值为95.39%,阴性预测值为94.71%,复检率42.22%,并无恶性血液病漏诊,验证结果表明此版规则合理,适用于中国医学科学院血液病医院。结论通过制定适合于该院的血细胞分析复检规则,既可提高血常规检测的效率,又能保证结果的可靠性,降低漏诊率的发生,且提高了检测的质量。Objective The hematology review criteria which is suitable for inpatients of Tianjin Hematonosis Hospital was established according to 41 items of review criteria suggested by the International Consensus Group for Hematology Review,27 items of review criteria established by domestic experts,and analysis of experimental data.Methods The total 484 inpatient samples were randomly collected and detected by automated hematology analyzer Sysmex XN-9000.The blood smear was also performed with microscopic examination.The false positive rate (FP),false negative rate (FN),true negative rate (TN),positive predictive value (PPV),negative predictive value (NPV)and the ratio of review were calculated.Through revising parts of the old review criteria, the rational review criteria for this hospital was set up and validated by analysis of the experiment data and the local situation.Results With the microscopic examination as the gold standard,the samples were analyzed by using the preliminary review criteria.FP was 3.72%,FN was 6.40%,PPV was 91.82%,NPV was 88.26%,and the ratio of review was 45.45%.Because of the unqualified omission ratio,the review criteria was modified and verified with another 360 samples.This time,FP was 1.94%,FN was 3.06%,PPV was 95.39%,NPV was 94.71% and the ratio of review was 42.22%.The verification results showed that no hematologic malignant disease was missed.The revised review criteria is rational.Conclusion Establishing the suitable review criteria for Tianjin Hematonosis Hospital not only can enhance work efficiency but also ensure the reliability of hematology analysis.

关 键 词：XN-9000全自动血液分析流水线 血细胞计数 显微镜检查 复检规则 

分 类 号：R446.11[医药卫生—诊断学]