International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain

A. M.H.P. van den Besselaar, V. Chantarangkul, F. Angeloni, N. B. Binder, M. Byrne, R. Dauer, B. R. Gudmundsdottir, J. Jespersen, S. Kitchen, C. Legnani, T. L. Lindahl, R. A. Manning, M. Martinuzzo, O. Panes, V. Pengo, A. Riddell, S. Subramanian, A. Szederjesi, C. Tantanate, P. HerbelA. Tripodi

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Essentials: Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6%. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7%. Summary: Background: The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods: An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results: Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions: The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain.

Original languageEnglish
Pages (from-to)142-149
JournalJournal of Thrombosis and Haemostasis
Volume16
Issue number1
DOIs
Publication statusPublished - 2018

Fingerprint

Thromboplastin
Calibration
Rabbits
International Normalized Ratio
Vitamin K
Running
Anticoagulants
Guidelines

Keywords

  • Anticoagulants
  • Calibration
  • International Normalized Ratio
  • Prothrombin time
  • Thromboplastin

ASJC Scopus subject areas

  • Hematology

Cite this

International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain. / van den Besselaar, A. M.H.P.; Chantarangkul, V.; Angeloni, F.; Binder, N. B.; Byrne, M.; Dauer, R.; Gudmundsdottir, B. R.; Jespersen, J.; Kitchen, S.; Legnani, C.; Lindahl, T. L.; Manning, R. A.; Martinuzzo, M.; Panes, O.; Pengo, V.; Riddell, A.; Subramanian, S.; Szederjesi, A.; Tantanate, C.; Herbel, P.; Tripodi, A.

In: Journal of Thrombosis and Haemostasis, Vol. 16, No. 1, 2018, p. 142-149.

Research output: Contribution to journalArticle

van den Besselaar, AMHP, Chantarangkul, V, Angeloni, F, Binder, NB, Byrne, M, Dauer, R, Gudmundsdottir, BR, Jespersen, J, Kitchen, S, Legnani, C, Lindahl, TL, Manning, RA, Martinuzzo, M, Panes, O, Pengo, V, Riddell, A, Subramanian, S, Szederjesi, A, Tantanate, C, Herbel, P & Tripodi, A 2018, 'International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain', Journal of Thrombosis and Haemostasis, vol. 16, no. 1, pp. 142-149. https://doi.org/10.1111/jth.13879
van den Besselaar, A. M.H.P. ; Chantarangkul, V. ; Angeloni, F. ; Binder, N. B. ; Byrne, M. ; Dauer, R. ; Gudmundsdottir, B. R. ; Jespersen, J. ; Kitchen, S. ; Legnani, C. ; Lindahl, T. L. ; Manning, R. A. ; Martinuzzo, M. ; Panes, O. ; Pengo, V. ; Riddell, A. ; Subramanian, S. ; Szederjesi, A. ; Tantanate, C. ; Herbel, P. ; Tripodi, A. / International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain. In: Journal of Thrombosis and Haemostasis. 2018 ; Vol. 16, No. 1. pp. 142-149.
@article{3117a60bdba744f2a9a83aef3b19a1ee,
title = "International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain",
abstract = "Essentials: Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6{\%}. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7{\%}. Summary: Background: The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods: An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results: Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10{\%}. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6{\%}), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7{\%}). Conclusions: The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain.",
keywords = "Anticoagulants, Calibration, International Normalized Ratio, Prothrombin time, Thromboplastin",
author = "{van den Besselaar}, {A. M.H.P.} and V. Chantarangkul and F. Angeloni and Binder, {N. B.} and M. Byrne and R. Dauer and Gudmundsdottir, {B. R.} and J. Jespersen and S. Kitchen and C. Legnani and Lindahl, {T. L.} and Manning, {R. A.} and M. Martinuzzo and O. Panes and V. Pengo and A. Riddell and S. Subramanian and A. Szederjesi and C. Tantanate and P. Herbel and A. Tripodi",
year = "2018",
doi = "10.1111/jth.13879",
language = "English",
volume = "16",
pages = "142--149",
journal = "Journal of Thrombosis and Haemostasis",
issn = "1538-7933",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain

AU - van den Besselaar, A. M.H.P.

AU - Chantarangkul, V.

AU - Angeloni, F.

AU - Binder, N. B.

AU - Byrne, M.

AU - Dauer, R.

AU - Gudmundsdottir, B. R.

AU - Jespersen, J.

AU - Kitchen, S.

AU - Legnani, C.

AU - Lindahl, T. L.

AU - Manning, R. A.

AU - Martinuzzo, M.

AU - Panes, O.

AU - Pengo, V.

AU - Riddell, A.

AU - Subramanian, S.

AU - Szederjesi, A.

AU - Tantanate, C.

AU - Herbel, P.

AU - Tripodi, A.

PY - 2018

Y1 - 2018

N2 - Essentials: Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6%. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7%. Summary: Background: The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods: An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results: Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions: The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain.

AB - Essentials: Two candidate International Standards for thromboplastin (coded RBT/16 and rTF/16) are proposed. International Sensitivity Index (ISI) of proposed standards was assessed in a 20-centre study. The mean ISI for RBT/16 was 1.21 with a between-centre coefficient of variation of 4.6%. The mean ISI for rTF/16 was 1.11 with a between-centre coefficient of variation of 5.7%. Summary: Background: The availability of International Standards for thromboplastin is essential for the calibration of routine reagents and hence the calculation of the International Normalized Ratio (INR). Stocks of the current Fourth International Standards are running low. Candidate replacement materials have been prepared. This article describes the calibration of the proposed Fifth International Standards for thromboplastin, rabbit, plain (coded RBT/16) and for thromboplastin, recombinant, human, plain (coded rTF/16). Methods: An international collaborative study was carried out for the assignment of International Sensitivity Indexes (ISIs) to the candidate materials, according to the World Health Organization (WHO) guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists. Results: Results were obtained from 20 laboratories. In several cases, deviations from the ISI calibration model were observed, but the average INR deviation attributabled to the model was not greater than 10%. Only valid ISI assessments were used to calculate the mean ISI for each candidate. The mean ISI for RBT/16 was 1.21 (between-laboratory coefficient of variation [CV]: 4.6%), and the mean ISI for rTF/16 was 1.11 (between-laboratory CV: 5.7%). Conclusions: The between-laboratory variation of the ISI for candidate material RBT/16 was similar to that of the Fourth International Standard (RBT/05), and the between-laboratory variation of the ISI for candidate material rTF/16 was slightly higher than that of the Fourth International Standard (rTF/09). The candidate materials have been accepted by WHO as the Fifth International Standards for thromboplastin, rabbit plain, and thromboplastin, recombinant, human, plain.

KW - Anticoagulants

KW - Calibration

KW - International Normalized Ratio

KW - Prothrombin time

KW - Thromboplastin

UR - http://www.scopus.com/inward/record.url?scp=85036558069&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85036558069&partnerID=8YFLogxK

U2 - 10.1111/jth.13879

DO - 10.1111/jth.13879

M3 - Article

AN - SCOPUS:85036558069

VL - 16

SP - 142

EP - 149

JO - Journal of Thrombosis and Haemostasis

JF - Journal of Thrombosis and Haemostasis

SN - 1538-7933

IS - 1

ER -