STA-Liatest纤维蛋白(原)降解产物性能的多中心评价  

A Multi-center evaluation study of STA-Liatest FDP

作　　者：张利伟[1] 井娜[2] 司力[3] 杨佰霞[3] 宋鉴清[4] 张宁[5] 鲍渝霞[6] 沈韻[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院检验科,上海200025 [2]中国医学科学院阜外心血管病医院检验科,北京100037 [3]安徽医科大学第一附属医院检验科,安徽合肥230022 [4]中国医科大学附属第一医院检验科,辽宁沈阳110001 [5]西安交通大学医学院第一附属医院检验科,陕西西安710061 [6]昆明医学院第一附属医院检验科,云南昆明650032

出　　处：《诊断学理论与实践》2014年第5期533-537,共5页Journal of Diagnostics Concepts & Practice

摘　　要：目的 :评价STA-Liatest纤维蛋白(原)降解产物[fibrin(ogen)degradation products,FDP]试剂在STA-R Evolution全自动血凝仪上的性能。方法 :选择质控血浆、患者血浆及健康成人血浆样本总共360份,在全国范围内按不同地域分布选取了6家医院进行多中心同步实验检测。分别使用STA-Liatest FDP和N-FDP,在STA-R Evolution全自动血凝仪上行FDP检测,检测结果参考美国临床实验室修正法规1988(CLIA88)标准要求进行统计分析。结果:STA-Liatest FDP多中心总的批内重复性,变异系数分别为8.0%(质控水平1)和4.7%(质控水平2);与N-FDP的相关系数为0.718(P<0.05,FDP<5μg/m L)和0.983(P<0.01,FDP≥5μg/m L);稳定性验证中,同一瓶试剂连续使用3 d的重复性,变异系数≤11.5%。结论 :STA-Liatest FDP的上述性能指标符合临床实验室的质量要求,可为临床提供可靠的检测结果。同时,为保证检测系统的溯源性,建议实验室尽可能使用配套试剂,以最大限度保证检验结果的可靠性。Objective： To evaluate the performance of STA-Liatest FDP on STA-R Evolution analyzer. Methods： A total of 360 blood samples of patients, normal controls and samples for quality control were analyzed. Six hospitals from different districts of China were selected to perform the test synchronously. Fibrin/fibrinogen degradation products（FDP）was tested on STA-R Evolution coagulation analyzer using STA-Liatest FDP and N-FDP, respectively. All the test results were analyzed statistically based on US Clinical Laboratory Improvement Amendment of 1988（CLIA88）. Results： The overall intra-batch repeatability at QC level one and level two were with a coefficient of variation 8% and 4.7%, respectively; the correlation coefficient between STA-Liatest FDP and N-FDP were 0.718（P〈0.05, FDP〈5μg /m L） and 0.983（P〈0.01, FDP≥5 μg/m L）, respectively. For stability, the repeatability of consecutive 3-day use of the same vial of STALiatest FDP was CV≤11.5%. Conclusions： All the performances of STA-Liatest FDP mentioned above meet the laboratory requirement and could provide reliable data for clinicians. Meanwhile, reagents provided by the original manufacturer are recommended for ensuring the quality of test result.

关 键 词：纤维蛋白(原)降解产物 检测 评价 

分 类 号：R446.11[医药卫生—诊断学]