Highlights
- •Measurement uncertainty (MU) estimation has become an important process in clinical laboratories.
- •Complex mathematical calculations made it difficult to estimate the MU of international sensitivity index (ISI).
- •Monte Carlo simulation (MCS) is one of the alternatives for evaluating the MU.
- •We demonstrated that MCS is adequate to estimate the MU of ISI.
Abstract
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, Asnières-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.
Keywords
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Article info
Publication history
Published online: February 13, 2023
Accepted:
February 10,
2023
Received in revised form:
February 9,
2023
Received:
August 29,
2022
Identification
Copyright
© 2023 Elsevier Ltd. All rights reserved.
