SYSMEX CS 5100全自动血凝分析仪的性能评价  

Evaluation on the performance of Sysmex CS 5100 automatic blood coagulation analyzer

作　　者：王芳[1] 张军[1] 徐唯傑 乐军[1] 陈晓燕[1] 陈晋[1] 

机构地区：[1]同济大学附属上海市肺科医院检验科,上海200433

出　　处：《检验医学》2015年第2期177-180,共4页Laboratory Medicine

基　　金：上海市肺科医院结核诊疗中心项目(检验科)

摘　　要：目的对Sysmex CS 5100（下简称CS 5100）全自动血凝仪进行性能评价。方法对CS 5100血凝仪的准确性、不精密度、Fg线性（可报告范围）、参考范围、携带污染率进行评价,并与Sysmex公司生产的CA 7000全自动血凝分析仪进行相关性试验,所测指标为PT、PT（INR）、APTT、Fbg、TT、AT、D二聚体（DD）和FDP。结果准确性试验测定结果在质控说明书给定的范围内。批内最大变异系数（CV）与日间最大CV均符合符合相关行业文件要求。Fbg线性验证试验结果显示Fbg线性范围为1.071～5.355,相关系数（r）值为0.995 0,符合规定要求（r≥0.975）。参考范围验证试验结果显示各项检测指标R值均〉0.9,实验室预设参考范围可适用于该仪器。CS 5100与CA 7000的各项检测项目r值均〉0.95,两仪器结果有很好的对比性。结论 CS 5100有优异的准确性、精密度良好、Fbg检测范围宽、抗生物干扰能力强,完全可满足临床实验室要求。Objective To evaluate the performance of Sysmex CS 5100 automatic blood coagulation analyzer.Methods PT,PT（ INR）,APTT,Fbg,TT,AT,D-dimer（ DD） and FDP were measured by Sysmex CS 5100 automatic blood coagulation analyzer. The accuracy,imprecision,Fg linearity（ reportable range）,reference range,carry-over rate were evaluated,and the correlation with Sysmex CA 7000 automatic blood coagulation analyzer was analyzed. Results The accuracy was in the range provided by quality control instructions. The maximum within-run and inter-day coefficients of variation met the requirements of Clia＇88. Fbg linear validation test showed that the linearity of Fbg was from 1. 071 to 5. 355,and the correlation coefficient（ r） was 0. 9950,which met the specified requirements（ r≥0. 975）. The reference range verification tests showed that the R values of all the tests were〉 0. 9,which proved that the laboratory preset reference range can be applied to the analyzer. The r for several items between CS 5100 and CA 7000 were 〉0. 95,which showed good correlation between the 2 analyzers. Conclusions CS 5100 has an excellent accuracy,a good precision,a wide range of Fbg detection as well as a strong anti-interference ability. CS 5100 can totally meet the requirements of clinical laboratories.

关 键 词：CS 5100 全自动血凝仪 性能评估 

分 类 号：R446.11[医药卫生—诊断学]