Sysmex CS5100全自动凝血分析仪性能评价比较分析  

Comparative Analysis of Performance Evaluation of Sysmex CS5100 Automatic Coagulation Analyzer

作　　者：齐晓芸 QI Xiao-yun(Laboratory Department,People’s Hospital of Wuyuan County,Shangrao City,Jiangxi Province,Jiangxi Shangrao 333200)

机构地区：[1]江西省上饶市婺源县人民医院检验科,江西上饶333200

出　　处：《中国医疗器械信息》2024年第2期76-78,共3页China Medical Device Information

摘　　要：目的:比较分析Sysmex CS5100全自动凝血分析仪性能。方法:从婺源县人民医院门诊与病房患者取线性验证、检测限试验、携带污染率试验标本,从健康体检人群取验证生物参考区间标本。采用Sysmex CS5100全自动凝血分析仪及其配套试剂分析准确度验证、不精密度验证、线性验证、检测限试验、携带污染率试验、正常参考范围验证结果。结果:APTT、PT、TT、FIB、FDP、D-D结果均在各质控品表示的可控范围内。APTT、PT、TT、FIB、FDP、D-D结果均比厂家表示的要求低。FIB、FDP、D-D回归方程分别为Y=0.9888X+0.1457、Y=0.9909X+1.0097、Y=0.9663X+0.066,r分别为0.9989、0.9987、0.9967,线性范围分别为0.38~6.74、2.21~72.36、0.17~10.91。斜率b值、r分别≤(1±0.05)、≥0.975,与要求相符。FIB、FDP、D-D检测限CV均≤20%,与要求相符。APTT、PT、TT、FIB、FDP、D-D异常样本对正常样本、正常样本对异常样本的携带污染率均在厂家标识的±10%范围内。APTT、PT、TT、FIB的正常参考范围均在厂家标识的范围内。结论:Sysmex CS5100全自动凝血分析仪具有较好的性能,具有较好的精密度、较高的准确度、较宽的检测范围、较低的携带污染率。Objective:To evaluate and analyze the performance of Sysmex CS5100 automatic coagulation analyzer.Methods:Samples for linearity verification,detection limit test,and carryover contamination rate test were taken from outpatients and ward patients(Wuyuan County People’s Hospital),and biological reference interval samples were taken from healthy people for physical examination.Analytical accuracy verification,imprecision verification,linearity verification,detection limit test,carryover contamination rate test,and normal reference range verification results by Sysmex CS5100 automatic coagulation analyzer and its supporting reagents.Results:The results of APTT,PT,TT,FIB,FDP,and D-D were all within the controllable range indicated by each quality control product.The results of APTT,PT,TT,FIB,FDP,and D-D are all lower than the requirements indicated by the manufacturer.FIB,FDP,and D-D regression equations are Y=0.9888X+0.1457,Y=0.9909X+1.0097,Y=0.9663X+0.066,r are 0.9989,0.9987,0.9967,and the linear ranges are 0.38-6.74,2.21-72.36,0.17-10.91.The slope b value and r≤(1±0.05)and≥0.975 respectively,which meet the requirements.FIB,FDP,and D-D detection limit CV are all≤20%,which is in line with the requirements.The carrying contamination rates of APTT,PT,TT,FIB,FDP,and D-D abnormal samples to normal samples,and normal samples to abnormal samples were all within±10%of the manufacturer’s label.The normal reference ranges of APTT,PT,TT,and FIB are all within the range marked by the manufacturer.Conclusion:Sysmex CS5100 automatic coagulation analyzer has good performance,good precision,high accuracy,wide detection range and low carryover rate.

关 键 词：全自动凝血分析仪 Sysmex CS5100 性能 

分 类 号：R446.1[医药卫生—诊断学]