Destiny Max全自动血凝分析仪的性能评价  

Evaluation on the performance of Destiny Max automatic coagulation analyzer

作　　者：郑加永 夏淑琦 魏国忠 马卫德 汪海 王晗 张德亭 

机构地区：[1]温州市人民医院 [2]温州市妇幼保健院妇产科实验室,浙江温州325000

出　　处：《检验医学》2013年第12期1116-1120,共5页Laboratory Medicine

摘　　要：目的对Destiny Max全自动血凝分析系统（简称Desting Max）的主要性能指标进行评价。方法按照美国临床实验室标准化协会（CLSI）的相关文件对Destiny Max进行精密度、检出限、线性、携带污染率和试剂稳定性评价，并与Stago STA—R血凝分析系统（简称StagoSTA—R）进行比较。评价项目为血浆凝血酶原时间（PT）、国际标准化比值（INR）、活化部分凝血活酶时间（APTF）、凝血酶时间（TT）及纤维蛋白原（FIB）。结果Destiny Max各检测项目批内精密度[变异系数（CV）]均〈3％，批间精密度（CV）均低于1／3总误差；FIB的检出限为0．50g／L，在0．90～8．97g／L范围内均有良好的线性；携带污染率均低于1／4总误差；试剂开瓶后在15d内结果稳定，各检测项目CV均〈10％。Destiny Max与Stago STA—R相关性分析显示，除APTT相关系数（／2）为0．8134外，PT、INR、FIB的r2〉0．95，结果均呈高度相关。结论DestinyMax精密度高，线性范围、检出限值、携带污染率达到要求，试剂稳定期长，性能稳定可靠，适合于各级医院临床应用。Objective To evaluate the main performance parameters of Destiny Max automatic coagulation analyzer （ Destiny Max analyzer）. Methods According to the Clinical and Laboratory Standards Institute （CLSI） document, the precision, detection limit, linearity, contamination rate and stability of Destiny Max analyzer were evaluated, and the results were compared with those by Stago STA-R coagulation system （Stago STA-R analyzer）. The evaluation parameters included prothrombin time （PT）, international standardization ratio （INR）, activated partial thromboplastin time （APTT） , thrombin time （TT） and fibrinogen （FIB）. Results The within-run coefficients of variation （CV） of all the results detected by Destiny Max analyzer were 〈 3% , and the between-run CV were 〈 1/3 total error. The detection limit of FIB was 0. 50 g/L, and it had good linearity in the range of 0. 90-8. 97 g/L. The results of contamination rate were less than 1/4 of total error. The resuhs were stable within 15 d after open vial reconstituted. The CV of all the results were 〈 10%. The correlation of Destiny Max analyzer, and Stago STA-R analyzer showed that except the coefficient of correlation （r2） of AtrgF was 0. 813 4,the results of PT,INR and FIB were in high correlation （r2 〉 0.95 ）. Conclusions The precision, linearity, detection limit and contamination rate of Destiny Max analyzer meet the requirements. The stability of reagents and performance of Destiny Max analyzer are quite good and suitable for the clinical application.

关 键 词：性能评价 全自动血凝分析仪 检出限 线性范围 

分 类 号：R446.11[医药卫生—诊断学]