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目的:建立一套适合本地区的半自动血凝仪性能评价指标与鉴定的方法,同时应用该法对本地区常用的4种血凝仪:美国BECKMANCOULTER公司ACL1 0 0血凝仪、BE公司TRT -C血凝仪、普力生公司C - 2 0 0 0IV血凝仪、中勤世帝公司LG -PAD血凝仪进行评价。方法:准备不同浓度质控血浆、混合血浆、不同浊度与不同黄疸程度的混合血浆,由操作经验丰富的技术人员严格按照操作手册操作与准备试剂,4台仪器同时测定PT、APTT、FIB3个项目,对精密度、线性、仪器间相关性进行评价;同时进行脂浊、黄疸干扰实验;测定数据使用PEMS3.0统计软件分析,OfficeExcel制图。结果:精密度测定总体上看ACL1 0 0的最好,其他仪器相差不大,可满足临床需要。线性范围测定:ACL1 0 0使用散射比浊法,FIB线性范围0 .4 3g/L6 .88g/L ;其他仪器都使用磁珠法原理,线性范围0 .86g/L6 .88g/L。相关性分析:4台仪器间有统计学差异。干扰实验:ACL1 0 0使用散射比浊法,高浑浊标本干扰测定,大多数的标本是没有脂浊可以测定;其他仪器都使用磁珠法,影响较小。4台仪器都有一定的抗黄疸干扰能力,ACL1 0 0使用散射比浊方法测定,非比色干扰小;其余仪器使用磁珠法,与颜色无关,干扰小。结论:4种被评估仪器的精密度、线性均符合要求,能满足临床实验室应用;ACL1 0 0在抗高脂
OBJECTIVE: To establish a set of performance evaluation index and identification method suitable for semi-automatic blood coagulation analyzer in this area. At the same time, four coagulation analyzer commonly used in this area, such as ACL1 0 0 blood coagulation analyzer of BECKMAN COULTER, TRT-C Coagulation analyzer, Prussia C - 2000IL blood coagulation analyzer, the company on the Qin Shi LG - PAD coagulation analyzer for evaluation. Methods: The preparation of mixed plasma with different concentrations of quality control plasma, mixed plasma, different turbidity and different jaundice, operated by experienced technicians in strict accordance with the operation manual and preparation of reagents, 4 instruments simultaneous determination of PT, APTT, FIB3 Project, the precision, linearity, evaluation of the correlation between instruments; at the same time lipophilic, jaundice interference experiments; measured data using PEMS3.0 statistical software analysis, OfficeExcel drawing. Results: In general, the precision of ACL1 0 0 was the best, while the other instruments were not different enough to meet the clinical needs. Linear range determination: ACL1 0 0 using the turbidimetric method, FIB linear range 0. 4 3g / L6. 88g / L; other instruments using the magnetic bead method, the linear range of 0.86g / L6. Correlation analysis: There are statistical differences among the four instruments. Interference test: ACL1 0 0 using turbidimetric method, high turbidity specimens interference determination, most of the specimens are no turbidity can be measured; other instruments are used beads method, the impact is small. 4 instruments have a certain ability to interfere with jaundice, ACL1 0 0 using the turbidimetric method of scattering, non-colorimetric interference is small; the rest of the instrument using magnetic beads method, has nothing to do with the color, interference small. Conclusion: The precision and linearity of the 4 kinds of evaluated instruments meet the requirements and meet the needs of clinical laboratory. ACL1 0 0