CN-3000全自动血凝仪检测凝血七项的性能验证  

A Performance Verification of CN-3000 Automatic Blood CoagulationAnalyzer for Seven Routine Blood Coagulation Tests

作　　者：罗国菊 寿炜龄 陈倩[1] 刘丹[1] 吴卫[1] LUO Guoju;SHOU Weiling;CHEN Qian;LIU Dan;WU Wei(Department of Clinical Laboratory,Peking Union Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730

出　　处：《标记免疫分析与临床》2022年第7期1204-1208,共5页Labeled Immunoassays and Clinical Medicine

基　　金：北京市临床重点专科医学检验科卓越项目(编号:2K201000);北京市科学技术委员会AI+健康协同创新培育项目(编号:Z221100003522004)。

摘　　要：目的对Sysmex CN-3000全自动血凝仪检测常规凝血七项进行性能验证。方法依据美国临床实验室标准化委员会(CLSI)EP文件及行业标准WS/T406-2012文件,对活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)、纤维蛋白原(FIB)、凝血酶时间(TT)、D-二聚体(D-dimer,D-D)、纤维蛋白原降解产物(FDP)和抗凝血酶(AT)的精密度、准确度、线性范围、方法间比对、携带污染和参考区间等性能进行验证,并比较Sysmex CN-3000与Sysmex CS 5100仪器的APTT凝固曲线报警信息。结果APTT、PT、FIB、TT、D-dimer、FDP和AT的实验室内总不精密度(CV-_(实验室内))分别为0.79%~2.63%、2.14%~3.34%、3.49%~4.87%、1.60%~2.37%、3.81%~4.02%、2.54%~2.97%、4.12%~6.57%,准确度结果均在靶值允许范围内。线性验证的理论值和实测值的线性回归方程斜率在(1±0.05)范围内且R^(2)≥0.995。所有项目在Sysmex CN-3000与Sysmex CS-5100两台仪器之间结果一致性好,且在医学决定水平处的偏移均在可接受范围内。25例标本在CS-5100仪器有早凝或凝固曲线报警,其中88%(22例/25例)的标本在CN-3000仪器无类似报警。所有项目参考区间验证通过。结论CN-3000全自动血凝仪性能验证符合要求,可用于临床标本的检测。Objective To verify the performance of Sysmex CN-3000 fully automatic coagulation analyzer in detecting seven routine blood coagulation tests.Methods According to the EP document of Clinical and Laboratory Standards Institute(CLSI)and the WS/T406-2012 industry standard,the precision,accuracy,linearity,comparison between the newly installed and confirmed coagulation analyzers,carry over and reference interval of activated partial thromboplastin time(APTT),prothrombin time(PT),fibrinogen(Fib),thrombin time(TT),D-dimer(D-D),fibrinogen degradation product(FDP)and antithrombin(AT)were evaluated.APTT clotting curve alarm information was compared between Sysmex CN-3000 and Sysmex CS-5100 coagulation analyzer.Results The within-lab precision(CV-_(within))of APTT,PT,FIB,TT,D-Dimer,FDP and AT were 0.79%-2.63%,2.14%-3.34%,3.49%-4.87%,1.60%-2.37%,3.81%-4.02%,2.54%-2.97%,and 4.12%-6.57%,respectively.The accuracies were all within the allowable range of the target value.The slope of the linear regression equation of the actual and theoretical value was in the range of(1±0.05)and R^(2)≥0.995.All results of the comparability between Sysmex CN-3000 and Sysmex CS-5100 analyzer were in a good agreement with allowable bias at medical decision level.Twenty-five specimens had coagulation curve alarms on the CS-5100,of which 88%(22 cases/25 cases)had no similar alarms on CN-3000 analyzer.CN-3000 passed the reference interval verification.Conclusion The performance verification of CN-3000 automatic blood coagulation instrument meets the requirements and can be used in clinical practices.

关 键 词：凝血检测 性能验证 凝固曲线 

分 类 号：R446.112[医药卫生—诊断学]