Performance verification of diluted thrombin time assay for detecting Dabigatran level in plasma
10.13602/j.cnki.jcls.2017.12.07
- VernacularTitle:稀释凝血酶时间试验检测血浆达比加群水平的性能评价
- Author:
Xue-Lian WU
1
;
Chen-Xue QU
;
Ju-Hua DAI
;
Li-Ping LI
;
Yan GONG
;
Yao LU
;
Jia-Ying YUAN
;
Lian-Fang NI
Author Information
1. 北京大学第一医院检验科
- Keywords:
Dabigatran;
anticoagulation monitoring;
diluted thrombin time;
performance verification
- From:
Chinese Journal of Clinical Laboratory Science
2017;35(12):903-907
- CountryChina
- Language:Chinese
-
Abstract:
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.
