Aims: To compare the International Normalised Ratio (INR) obtained directly with the two types of WHO plain International Reference Preparation for thromboplastin in patients treated with coumarin.
Methods: Prothrombin times were performed in parallel at four centres using WHO human plain IRP (BCT/253) and rabbit plain IRP (RBT/79). Sixty patients and 20 normal controls were tested at each centre. Differences in INR among the centres were assessed by one factor, analysis of variance. The bias for each centre was assessed by the t test.
Results: At all four centres higher INRs were consistently found with the rabbit plain reagent. Two of the centres showed significantly greater bias.
Conclusions: There was a small but significant difference in INR results obtained directly with these two reference reagents at all four centres (mean 7.35%). This in part may result from the different responsiveness of the two IRP to the coumarin defect or to imprecision of the original ISI calibrations of the two plain WHO IRP. The findings support the adoption of a single master IRP, in accord with WHO recommendations, which would resolve the present anomalous situation.
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http://dx.doi.org/10.1136/jcp.46.1.64 | DOI Listing |
Rinsho Byori
August 2002
Department of Laboratory Medicine, Tokyo Medical University, Shinjuku-ku, Tokyo.
This review regarding prothrombin time and its standardization is described around some recent topics as the followings. 1. History of standardization for prothrombin time and revised WHO guideline for thromboplastin; A short history of standardization is summarized to understand a scheme of International Normalized Ratio (INR) based on International Sensitivity Index (ISI) that is calibrated by International Reference Preparation (IRP) for thromboplastin, and some key points in revised WHO guideline for thromboplastin and plasma used to control oral anticoagulant therapy are interpreted for research and practical use.
View Article and Find Full Text PDFThromb Haemost
September 2002
Haemostasis and Thrombosis Research Centre, Leiden University Medical Centre, Leiden, The Netherlands.
Two established international reference preparations (IRP) for thromboplastins, i.e. RBT/90 (rabbit, plain) and rTF/95 (recombinant human, plain) have been calibrated against each other in a 7-centre exercise performed in 2000.
View Article and Find Full Text PDFJ Clin Pathol
April 1998
Department of Pathological Sciences, University of Manchester, UK.
Aim: To assess reliability of like to like and cross species calibrations using two types of certified freeze dried plasma calibrants--artificially depleted of vitamin K clotting factors, and from coumarin treated patients.
Methods: Six ECAA national control laboratories provided certified values for the freeze dried plasmas in terms of the human plain international reference preparation (IRP) (BCT/441) with the manual prothrombin time technique. Eight other ECAA national laboratories determined international sensitivity index (ISI) values in full fresh plasma same species and cross species WHO calibrations against a low ISI human IRP (BCT/441) of the ECAA low ISI human thromboplastin and high ISI ECAA rabbit thromboplastin.
Br J Haematol
June 1998
Central Facility, ECAA, Department of Pathological Sciences, University of Manchester, UK.
Artificially-depleted lyophilized plasmas and lyophilized coumarin plasmas were prepared and compared with fresh coumarin plasmas to assess their comparative reliability in local thromboplastin calibration using the manual prothrombin time (PT) technique. Their certified PT values were inserted in turn on the vertical axis in place of the PT obtained with fresh coumarin plasmas. PT results were obtained at eight ECAA national laboratories ('test centres') and inserted on the horizontal axis.
View Article and Find Full Text PDFThromb Haemost
February 1998
Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Institute of Internal Medicine, University and IRCCS Maggiore Hospital, Milano, Italy.
Stocks of the International Reference Preparation (IRP) for thromboplastin, human, plain, coded BCT/253 and held by the World Health Organization (WHO) are nearly exhausted and must be replaced. For practical reasons the choice of the replacement candidate was restricted to two available human recombinant preparations which were coded as X/95 and Y/95 and calibrated in an international collaborative study involving 19 laboratories from Europe, Australia, Canada and Argentina. To minimize the differences between routes of calibration, the two candidates were calibrated against the existing WHO-IRP from human, rabbit and bovine origin and the final ISI was the resultant average value.
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