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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/47254
Title: International collaborative study for the calibration of proposed International Standards for thromboplastin, rabbit, plain, and for thromboplastin, recombinant, human, plain
Authors: 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
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
Keywords: Medicine
Issue Date: 1-Jan-2018
Citation: Journal of Thrombosis and Haemostasis. Vol.16, No.1 (2018), 142-149
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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85036558069&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/47254
ISSN: 15387836
15387933
Appears in Collections:Scopus 2018

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