稀释凝血酶时间试验检测血浆达比加群水平的性能评价

摘要

Objective To evaluate the performance of diluted thrombin time (dTT) 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 dTT assay were evaluated and the stability of specimen for dTT assay was observed.Results Both the within-day and between-day coefficient of variation (CV) of dTT 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/mL.The carryover rate was-0.84％.There was no interference for Dabigatran levels by dTT assay for detecting Dabigatran when Hb≤3 g/L,triglyceride≤873 mg/dL,heparin≤2.2 IU/mL and FDP≤29 mg/L.The results of stability showed that plasma specimens for dTT 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 dTT assay.Conclusion The precision,trueness,analytical measurement range,carryover rate,anti-biological interference of dTT assay may meet the requirement of clinical laboratory.The stability of the specimen can fulfill the clinical requirements.%目的 评价稀释凝血酶时间(dTT)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dTT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 dTT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/mL范围内dTT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/dL、肝素≤2.2 IU/mL、FDP≤29 mg/L对dTT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4h,4℃不宜超过4d,-20℃不宜超过1个月,-80℃条件下可以存放半年.结论 dTT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.