Sysmex XS-1000i血细胞分析仪复检规则的建立与验证及报警信息的可信性分析  

Construction and Validation of Review Rules and Credibility of Flags Alarm for Sysmex XS-1000i Hematology Analyzer

作　　者：邱峰[1] 王会敏[1] 罗福东[1] 田敏[2] 

机构地区：[1]广东省中医院检验科,广东广州510120 [2]长治医学院医学检验系,山西长治046000

出　　处：《临床医学工程》2014年第3期265-266,269,共3页Clinical Medicine & Engineering

基　　金：广东省中医药局科研项目(NO.20121190);广东省人口和计划生育委员会科研项目(NO.20133061)

摘　　要：目的通过观察Sysmex XS-1000i血细胞分析仪Flags报警信息的敏感度、准确度及特异性,分析Flags报警信息的可靠性,建立适合本实验室的显微镜复检规则并验证其可行性。方法 1 040例全血分析标本同时进行仪器检测和手工显微镜镜检,分析仪器与镜检的符合率、准确度、敏感度、特异性、阳性预测值及阴性预测值。结果将仪器报警信息与镜检阳性结果进行比较,真阳性率13.8%,假阳性率6.4%,真阴性率78.4%,假阴性率1.4%。Sysmex XS-1000i对异常的血液标本检出能力的有关预测值分别为:敏感度98.6%,特异度93.6%,阳性符合率68.2%,阴性符合率98.2%,准确度92.2%。结论本实验室仪器1.4%的假阴性率符合国际血液学复审协作组关于假阴性率小于5.0%的规定,20.2%的复检率合理。本实验室制定的复检规则可行、可信,符合实际工作需要和质量要求。Objective To observe the sensitivity, accuracy and specificity of Sysmex XS-1000i hematology analyzer flags alarm information, and analyze its reliability, establish and verify the review rules. Methods Instrument detection and manual microscopy of 1 040 cases of blood samples were synchronized, and the instrument and microscopic coincidence rate, accuracy, sensitivity, specificity, positive predictive value and negative predictive value were analyzed. Results Comparison was performed between analyzer alarm information and the positive samples determined by microscope, the results showed that the real positive rate was 13.8%, the false positive rate was 6.4%, the real negative rate was 78.4%, and the false negative rate was 1.4%. The predictive value for detective capability of the analyzer for the abnormal blood samples were shown as follow： sensitivity was 98.6%, specificity was 93.6%, positive coincidence was 68.2%, negative coincidence was 98.2%, and accuracy was 92.2%. Conclusions The false negative rate （1.4%） of our laboratory is according with the false negative rate （〈5.0%） formulated by International Hematology Review Group. The review rate （20.2%） is reasonable. The review rules of our laboratory are feasible and credible, in accordance with the actual work and quality requirements.

关 键 词：血细胞分析仪 显微镜镜检 复检规则 Flags报警 

分 类 号：R318.6[医药卫生—生物医学工程]