安图AutoCimo C6000全自动凝血分析仪性能评估及与沃芬比对分析  

Performance evaluation of Antu AutoCimo C6000 fully automatic coagulation analyzer and comparison with Werfen

作　　者：胡天一 张倩倩[1] 王倩薇 HU Tianyi;ZHANG Qianqian;WANG Qianwei(Department of Medical Laboratory,the First Affiliated Hospital of Henan University,Kaifeng,Henan 475000,China)

机构地区：[1]河南大学第一附属医院医学检验科,河南开封475000

出　　处：《中国医学工程》2025年第4期1-5,共5页China Medical Engineering

摘　　要：目的对安图AutoCimo C6000全自动凝血分析仪的性能进行评估,并与沃芬进行比对分析,确定其应用价值。方法根据医学实验室质量和能力认可准则要求,对安图AutoCimoC6000全自动凝血分析仪检测凝血功能指标的性能进行评估,其中凝血功能指标包括凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIB)、D-二聚体(D-D)、纤维蛋白(原)降解产物(FDP)、抗凝血酶Ⅲ(AT-Ⅲ),性能指标包括批内精密度、日间精密度、准确度、携带污染率(CR)、线性范围、临床可报告范围和参考范围等,并将其评估结果与沃芬检测结果进行比对。结果PT、APTT、TT、FIB、D-D、FDP和AT-Ⅲ在质控水平1、质控水平2的批内精密度变异系数(CV),日间精密度CV,在质控水平1、质控水平2的准确度,FIBCR、FIB对APTTCR的检验结果,FIB、D-D、FDP、AT-Ⅲ线性范围检验结果,FIB、D-D、FDP、AT-Ⅲ的临床可报告范围均符合判断标准;PT、APTT、FIB、TT、D-D、FDP和AT-Ⅲ的实际参考范围与说明书参考范围均基本一致且R均为1,符合要求;通过安图AutoCimoC6000型全自动凝血分析仪检测患者标本分析PT、APTT、FIB、TT、D-D、FDP检测结果与沃芬750比对结果高度一致。结论安图AutoCimo C6000全自动凝血分析仪性能符合要求,且与沃芬750型全自动凝血分析仪检测结果高度一致。【Objective】To evaluate the performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer and compare it with Werfen to determine its application value.【Methods】The performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer was evaluated in detecting coagulation function indicators in accordance with the requirements of medical laboratory quality and capability recognition criteria.The coagulation function indicators included prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT),fibrinogen(FIB),D-dimer(D-D),fibrinogen degradation product(FDP),antithrombin Ⅲ(AT-Ⅲ),and the performance indicators included batch precision,daytime precision,accuracy,contamination rate(CR),linear range,clinically reportable range,and reference range.Then its evaluation results were compared with the results of the Werfen test.【Results】The test results of PT,APTT,TT,FIB,D-D,FDP,and AT-Ⅲ in batch precision CV and daytime precision CV at levels 1 and 2,and accuracy at levels 1 and 2,the test results of FIB CR and FIB on APTT CR,FIB,D-D,FDP,AT-Ⅲ linear range test results,the clinical reportable ranges of FIB,D-D,FDP,and AT-Ⅲ all met the judgment criteria.The actual reference ranges of PT,APTT,FIB,TT,D-D,FDP,and AT-Ⅲ were basically consistent with the reference range of the manual,and R values were all 1,which met the requirements.The PT,APTT,FIB,TT,D-D,FDP detection results of patient specimens analyzed by Antu AutoCimo C6000 fully automatic coagulation analyzer were highly consistent with the comparison results of the Werfen 750 type.【Conclusion】The performance of the Antu AutoCimo C6000 fully automatic coagulation analyzer meets the requirements and is highly consistent with the detection results of the Werfen 750 fully automatic coagulation analyzer.

关 键 词：全自动凝血分析仪 性能 验证 沃芬 

分 类 号：R446.11[医药卫生—诊断学]