全自动血凝分析仪Sysmex CS-5100的性能验证与评价  

Performance verification and evaluation of Sysmex CS-5100 automatic coagulation analyzer

作　　者：张巧云[1] 彭华[1] 梁委军[1] 

机构地区：[1]广西医科大学第四附属医院暨柳州市工人医院医学检验科,柳州545005

出　　处：《右江医学》2016年第1期82-87,共6页Chinese Youjiang Medical Journal

摘　　要：目的对全自动血凝分析仪Sysmex CS-5100的性能进行验证与评价。方法用高低浓度混合血浆验证批内精密度,用高低浓度质控品验证日间精密度,用高浓度混合血浆分别按100%、80%、60%、40%、20%、10%、5%的比例稀释后对仪器进行线性验证,用接近预期检测限的低/高浓度血浆样本来验证可报告范围,通过检测定值质控品和仪器比对来验证正确度,用正常体检血浆验证参考区间,用高低浓度血浆标本验证携带污染率。结果 Sysmex CS-5100检测PT、APTT、FIB批内CV〈3.0%;TT、D-二聚体、FDP批内CV〈4.0%;PT、APTT、FIB日间CV〈5.0%;TT、D-二聚体、FDP日间CV〈6.0%;FIB、D-二聚体、FDP的可报告范围分别是：0.21-24.6 g/L,0.06-89.6 mg/L,0.09-2001.28μg/ml;各项目相对偏差均在10.5%以内;95%以上样本处于引用参考区间内,携带污染率均〈2.5%。结论 Sysmex CS-5100全自动血凝分析仪性能良好,可用于检测临床样本。Objective To verify and evaluate the performance of Sysmex CS-5100 automatic coagulation analyzer. Methods In-run precision was verified by high / low concentration mixed blood plasma,between-day precision was verified by high / low concentration quality control sample,high concentrations of mixed plasma was used to verify the linear with the dilution ratio of 100%,80%,60%,40%,20%,10% and 5%,respectively. High / low concentration close to expected detection limit was used to verify reportable range,accuracy was verified by detecting fixed value quality control sample and equipment comparison,normal physical examination plasma was carried on to verify reference range,and high / low concentration blood plasma was used to verify contaminative rate. Results The in-run precision of PT,APTT and FIB detection were all less than 3. 0%,TT,D-Dimer,FDP detection were all less than 4. 0%. The between-day precision of PT,APTT and FIB detection were all less than 5. 0%,and TT,D-Dimer,FDP detection were all less than 6. 0%. The reportable range of FIB,D-Dimer,FDP were 0. 21 - 24. 6 g / L,0. 06 - 89. 6 mg / L and 0. 09 - 2001. 28 μg / m L,respectively. The bias of each items were within 10. 5%,more than 95% of the sample in quoting reference range,contaminative rate was all 2. 5%.Conclusion Sysmex CS-5100 show a good performance,and can be used for detection of clinical samples.

关 键 词：SYSMEX CS-5100 血凝分析仪 性能验证 

分 类 号：R446.1[医药卫生—诊断学]