PMID- 36099012
OWN - NLM
STAT- MEDLINE
DCOM- 20221012
LR  - 20221015
IS  - 1098-2825 (Electronic)
IS  - 0887-8013 (Print)
IS  - 0887-8013 (Linking)
VI  - 36
IP  - 10
DP  - 2022 Oct
TI  - Validation of high concentrated thrombin time assay for unfractionated heparin 
      monitoring.
PG  - e24695
LID - 10.1002/jcla.24695 [doi]
LID - e24695
AB  - BACKGROUND: The high concentrated thrombin time (hcTT), a thrombin time modified 
      by increasing the thrombin concentration, is a possible alternative assay to 
      activated partial thromboplastin time (aPTT) in unfractionated heparin (UFH) 
      monitoring. This study aimed to determine the optimal thrombin concentration used 
      in the hcTT assay for UFH monitoring. METHODS: A total of 30 blood samples 
      obtained from healthy volunteers were included in this study. Thrombin 
      concentrations of 10.0, 15.0, 20.0, and 25.0 IU/ml were used in the hcTT assay. 
      The consistency between the hcTT and anti-FXa assays was evaluated. To validate 
      the hcTT assay, linearity, repeatability, reproducibility, and diagnostic 
      performance of the assay were assessed. RESULTS: The hcTT assay using thrombin 
      concentration of 15.0 IU/ml showed a strong correlation to the anti-FXa assay 
      with R(2) of 0.72 and the Spearman's correlation coefficient (r(s) ) of 0.97 (95% 
      CI, 0.96-0.98). Within-run and day-to-day run variabilities of the assay were 
      satisfactory (all coefficients of variation <10%). We found an excellent 
      correlation between the results which were measured using different reagents with 
      intra- or inter-laboratory instruments. Notably, as compared to the aPTT assay, 
      the hcTT assay showed a significantly better performance in identifying the 
      samples which contain UFH at the supratherapeutic level, with an AUC of 0.97 vs. 
      0.91, p = 0.049. CONCLUSION: The hcTT assay can be used as an alternative assay 
      for UFH therapy monitoring. A further study using clinical samples is recommended 
      to confirm the appropriateness of the hcTT assay for clinical application.
CI  - (c) 2022 The Authors. Journal of Clinical Laboratory Analysis published by Wiley 
      Periodicals LLC.
FAU - Apipongrat, Dollapak
AU  - Apipongrat D
AUID- ORCID: 0000-0002-6654-6431
AD  - Division of Hematology, Department of Medicine, Phramongkutklao Hospital, 
      Bangkok, Thailand.
FAU - Police, Pornnapa
AU  - Police P
AUID- ORCID: 0000-0001-8067-538X
AD  - Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Lamool, Rattapan
AU  - Lamool R
AUID- ORCID: 0000-0002-8990-3462
AD  - Division of Hematology, Department of Medicine, Phramongkutklao Hospital, 
      Bangkok, Thailand.
FAU - Butthep, Punnee
AU  - Butthep P
AUID- ORCID: 0000-0002-7233-1920
AD  - Department of Medical Technology, Faculty of Allied Health Sciences, Pathumthani 
      University, Pathumthani, Thailand.
FAU - Chantkran, Wittawat
AU  - Chantkran W
AUID- ORCID: 0000-0001-7877-0222
AD  - Department of Pathology, Phramongkutklao College of Medicine, Bangkok, Thailand.
LA  - eng
PT  - Journal Article
DEP - 20220913
PL  - United States
TA  - J Clin Lab Anal
JT  - Journal of clinical laboratory analysis
JID - 8801384
RN  - 0 (Anticoagulants)
RN  - 9005-49-6 (Heparin)
RN  - EC 3.4.21.5 (Thrombin)
SB  - IM
MH  - Anticoagulants/therapeutic use
MH  - Drug Monitoring/methods
MH  - *Heparin
MH  - Humans
MH  - Partial Thromboplastin Time
MH  - Reproducibility of Results
MH  - *Thrombin
MH  - Thrombin Time
PMC - PMC9550976
OTO - NOTNLM
OT  - activated partial thromboplastin time
OT  - anti-FXa assay
OT  - assay validation
OT  - high concentrated thrombin time
OT  - unfractionated heparin monitoring
COIS- The authors state they have no conflict of interest.
EDAT- 2022/09/14 06:00
MHDA- 2022/10/13 06:00
PMCR- 2022/09/13
CRDT- 2022/09/13 11:54
PHST- 2022/05/31 00:00 [revised]
PHST- 2022/03/16 00:00 [received]
PHST- 2022/08/29 00:00 [accepted]
PHST- 2022/09/14 06:00 [pubmed]
PHST- 2022/10/13 06:00 [medline]
PHST- 2022/09/13 11:54 [entrez]
PHST- 2022/09/13 00:00 [pmc-release]
AID - JCLA24695 [pii]
AID - 10.1002/jcla.24695 [doi]
PST - ppublish
SO  - J Clin Lab Anal. 2022 Oct;36(10):e24695. doi: 10.1002/jcla.24695. Epub 2022 Sep 
      13.