PMID- 36812877
OWN - NLM
STAT- MEDLINE
DCOM- 20230320
LR  - 20230328
IS  - 1879-2472 (Electronic)
IS  - 0049-3848 (Linking)
VI  - 224
DP  - 2023 Apr
TI  - Estimating the measurement uncertainties of the international sensitivity index 
      of 12 thromboplastins through Monte Carlo simulation.
PG  - 32-37
LID - S0049-3848(23)00046-4 [pii]
LID - 10.1016/j.thromres.2023.02.007 [doi]
AB  - BACKGROUND: Measurement uncertainty (MU) estimation has become an important 
      process in clinical laboratories; however, calculating the MUs of the 
      international sensitivity index (ISI) of thromboplastins is difficult because of 
      the complex mathematical calculations required in calibration. Therefore, this 
      study quantifies the MUs of ISIs through the Monte Carlo simulation (MCS), which 
      involves random sampling of numerical values to solve a complex mathematical 
      calculation. METHODS: Eighty blood plasmas and commercially available certified 
      plasmas (ISI Calibrate) were used to assign the ISIs of each thromboplastin. 
      Prothrombin times were measured using reference thromboplastin and 12 
      commercially available thromboplastins (Coagpia PT-N, PT Rec, ReadiPlasTin, 
      RecombiPlasTin 2G, PT-Fibrinogen, PT-Fibrinogen HS PLUS, Prothrombin Time Assay, 
      Thromboplastin D, Thromborel S, STA-Neoplastine CI Plus, STA-Neoplastine R 15, 
      and STA-NeoPTimal) with two automated coagulation instruments: ACL TOP 750 CTS 
      (ACL TOP; Instrumentation Laboratory, Bedford, MA, USA) and STA Compact 
      (Diagnostica Stago, Asnieres-sur-Seine, France). Then, the MUs of each ISI were 
      simulated through MCS. RESULTS: The MUs of ISIs ranged from 9.7 % to 12.1 % and 
      11.6 % to 12.0 % when blood plasma and ISI Calibrate were used, respectively. For 
      some thromboplastins, the ISI claimed by manufacturers significantly differed 
      from the estimated results. CONCLUSIONS: MCS is adequate to estimate the MUs of 
      ISI. These results would be clinically useful for estimating the MUs of the 
      international normalized ratio in clinical laboratories. However, the claimed ISI 
      significantly differed from the estimated ISI of some thromboplastins. Therefore, 
      manufacturers should provide more accurate information about the ISI value of 
      thromboplastins.
CI  - Copyright (c) 2023 Elsevier Ltd. All rights reserved.
FAU - Lim, Yong Kwan
AU  - Lim YK
AD  - Department of Laboratory Medicine, Chung-Ang University College of Medicine, 
      Seoul, South Korea.
FAU - Kweon, Oh Joo
AU  - Kweon OJ
AD  - Department of Laboratory Medicine, Chung-Ang University College of Medicine, 
      Seoul, South Korea.
FAU - Lee, Mi-Kyung
AU  - Lee MK
AD  - Department of Laboratory Medicine, Chung-Ang University College of Medicine, 
      Seoul, South Korea.
FAU - Kim, Hye Ryoun
AU  - Kim HR
AD  - Department of Laboratory Medicine, Chung-Ang University College of Medicine, 
      Seoul, South Korea. Electronic address: hyekim@cau.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20230214
PL  - United States
TA  - Thromb Res
JT  - Thrombosis research
JID - 0326377
RN  - 9035-58-9 (Thromboplastin)
RN  - 9001-32-5 (Fibrinogen)
SB  - IM
MH  - Humans
MH  - *Thromboplastin
MH  - Monte Carlo Method
MH  - Uncertainty
MH  - Prothrombin Time
MH  - International Normalized Ratio/methods
MH  - *Fibrinogen
MH  - Calibration
OTO - NOTNLM
OT  - International normalized ratio
OT  - International sensitivity index
OT  - Measurement uncertainty
OT  - Monte Carlo simulation
OT  - Prothrombin time
OT  - Thromboplastin
COIS- Declaration of competing interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2023/02/23 06:00
MHDA- 2023/03/21 06:00
CRDT- 2023/02/22 18:19
PHST- 2022/08/29 00:00 [received]
PHST- 2023/02/09 00:00 [revised]
PHST- 2023/02/10 00:00 [accepted]
PHST- 2023/02/23 06:00 [pubmed]
PHST- 2023/03/21 06:00 [medline]
PHST- 2023/02/22 18:19 [entrez]
AID - S0049-3848(23)00046-4 [pii]
AID - 10.1016/j.thromres.2023.02.007 [doi]
PST - ppublish
SO  - Thromb Res. 2023 Apr;224:32-37. doi: 10.1016/j.thromres.2023.02.007. Epub 2023 
      Feb 14.