稀释凝血酶时间试验检测血浆达比加群水平的性能评价  

Performance verification of diluted thrombin time assay for detecting Dabigatran level in plasma

作　　者：吴雪莲[1] 屈晨雪[1] 戴菊华 李丽萍[1] 龚岩[1] 陆遥[1] 袁家颖[1] 倪莲芳[2] 

机构地区：[1]北京大学第一医院检验科,北京100034 [2]北京大学第一医院老年科,北京100034

出　　处：《临床检验杂志》2017年第12期903-907,共5页Chinese Journal of Clinical Laboratory Science

摘　　要：目的评价稀释凝血酶时间(d TT)试验用于检测血浆达比加群水平的性能,观察其是否能满足临床实验室检测需求。方法参考美国临床和实验室标准化协会(CLSI)EP15-A2、EP6-A、EP7-A及C-24文件对d TT试验检测血浆达比加群水平的精密度、正确度、分析测量范围、携带污染率、抗生物干扰进行评价,并观察血浆样品的稳定性。结果 d TT试验检测血浆达比加群水平的日内、日间变异系数(CV)均符合厂家声明的CV;3个水平美国病理学家协会(CAP)能力验证计划物质达比加群浓度与靶值的相对偏差均<10%;在30.92~249.13 ng/m L范围内d TT试验检测达比加群水平结果呈线性分布;携带污染率为-0.84%;Hb≤3 g/L、三酰甘油≤873 mg/d L、肝素≤2.2 IU/m L、FDP≤29 mg/L对d TT试验检测达比加群水平无影响;血浆样品在常温保存不宜超过4 h,4℃不宜超过4 d,-20℃不宜超过1个月,-80℃条件下可以存放半年。结论 d TT试验检测达比加群浓度的精密度、正确度、分析测量范围、携带污染率、抗生物干扰能力基本符合实验室要求。血浆样品稳定性满足临床要求。Objective To evaluate the performance of diluted thrombin time（ d TT） assay for detecting Dabigatran levels and observe whether this assay may meet the requirements of clinical laboratory. Methods According to EP15-A2,EP6-A,EP7-A and C-24 documents of the Clinical and Laboratory Standards Institute（ CLSI）,the precision,trueness,analytical measurement range,carryover rate and anti-biological interference of d TT assay were evaluated and the stability of specimen for d TT assay was observed. Results Both the within-day and between-day coefficient of variation（ CV） of d TT assay for detecting Dabigatran levels were consistent with manufacturer＇s stated CV. Compared with target values of Dabigatran,the relative bias of 3 levels of proficiency test materials from College of American Pathologists（ CAP） were less than 10%. The results meet linear verification when Dabigatran concentration was between 30. 92 and 249. 13 ng/m L. The carryover rate was-0. 84%. There was no interference for Dabigatran levels by d TT assay for detecting Dabigatran when Hb≤3 g/L,triglyceride≤873 mg/d L,heparin≤2. 2 IU/m L and FDP≤29 mg/L. The results of stability showed that plasma specimens for d TT could not be stored at room temperature more than 4 hours,at 4 ℃ more than 4 days,at-20℃ exceed 1 month,while at-80℃ the plasma specimens could be stored at least 6 months for d TT assay. Conclusion The precision,trueness,analytical measurement range,carryover rate,anti-biological interference of d TT assay may meet the requirement of clinical laboratory. The stability of the specimen can fulfill the clinical requirements.

关 键 词：达比加群 抗凝监测 稀释凝血酶时间 性能验证 

分 类 号：R446.11[医药卫生—诊断学]