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

Issued Date

2018-01-01

Resource Type

Article

ISSN

15387836
15387933

DOI

10.1111/jth.13879

Other identifier(s)

2-s2.0-85036558069

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Journal of Thrombosis and Haemostasis. Vol.16, No.1 (2018), 142-149

Suggested Citation

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. Herbel, A. Tripodi 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 (2018), 142-149. doi:10.1111/jth.13879 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/47254

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Title

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

Author(s)

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. Herbel
 A. Tripodi

Other Contributor(s)

Imperial College Healthcare NHS Trust
 Roche Diagnostics GmbH
 Landspitali University Hospital
 Szent Laszlo Hospital
 Università degli Studi di Milano
 Pontificia Universidad Católica de Chile
 Alma Mater Studiorum Università di Bologna
 UCL
 Leiden University Medical Center - LUMC
 Faculty of Medicine, Siriraj Hospital, Mahidol University
 Trinity College Dublin
 Linköpings universitet
 Instituto Universitario del Hospital Italiano de Buenos Aires
 University of Southern Denmark, Esbjerg
 Royal Hallamshire Hospital
 St. John's Medical College Hospital
 Università degli Studi di Padova
 Technoclone GmbH
 Fondazione Luigi Villa
 Hemostasis Reference Laboratory
 Haematology Department

Abstract

© 2017 International Society on Thrombosis and Haemostasis 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.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/47254

Collections

Scopus 2018