European Concerted Action on Anticoagulation (ECAA) - The Multicentre Calibration of Rabbit and Human ECAA Reference Thromboplastins

L Poller; T W Barrowcliffe; A M H P van den Besselaar; J Jespersen; A Tripodi; D Houghton; Prepared on behalf of the ECAA by the above steering committee

doi:10.1055/s-0038-1650695

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 1996; 76(06): 0977-0982
DOI: 10.1055/s-0038-1650695

Original Article

Schattauer GmbH Stuttgart

European Concerted Action on Anticoagulation (ECAA) - The Multicentre Calibration of Rabbit and Human ECAA Reference Thromboplastins

Authors

L Poller

¹The Central Facility, ECAA, Department of Pathological Sciences, The University of Manchester, UK
T W Barrowcliffe

²Division of Haematology, National Institute for Biological Standards and Control, UK
A M H P van den Besselaar

³Haemostasis and Thrombosis Research Centre, Leiden University Hospital, The Netherlands
J Jespersen

⁴Department of Clinical Biochemistry, Centralsygehuset, Esbjerg, Denmark
A Tripodi

⁵A Bianchi Bonomi Hemophilia and Thrombosis Centre, University & IRCCS Maggiore Hospital, Milan, Italy
D Houghton

¹The Central Facility, ECAA, Department of Pathological Sciences, The University of Manchester, UK

Prepared on behalf of the ECAA by the above steering committee

Abstract

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Summary

Two candidate ECAA reference preparations have been calibrated in a multicentre exercise at 14 representative national laboratories to provide reference thromboplastin for a large field study in 16 European countries. Two preparations were required because of the established differences in ISI arising from the two main routes of calibration via rabbit and human IRP. To be comparable with working reagents in everyday use a human plain recombinant reagent of low ISI and a rabbit plain preparation of moderately high ISI were selected. A precise calibration of the two candidate preparations has been achieved with the manual PT technique and an ISI of 0.95 (SE 0.0078) for the human reagent and 1.67 (SE 0.0322) for the rabbit reagent.

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References

References
1 D’Angelo A, Seveso MP, D’Angelo SV, Gilardoni F, Macagni A, Manotti C. Comparison of two automated coagulometers and the manual tilt tube method for the determination of prothrombin time. Am J Clin Pathol 1989; 92: 321-328
2 Poller L, Thomson JM, Tabemer DA. Effect of automation on the prothrombin time test in NEQAS surveys. J Clin Pathol 1989; 42: 97-100
3 van Rijn JLML, Schmidt NicoA, Rutten W. Correction of instrument and reagent based differences in determination of the International Normalised Ratio (INR) for monitoring anticoagulant therapy. Clin Chem 1989; 355: 840-843
4 Ray MJ, Smith IR. The dependence of the International Sensitivity Index on the coagulometer used to perform the prothrombin time. Thromb Haemost 1990; 63: 424-429
5 Clarke K, Tabemer DA, Thomson JM, Morris JA, Poller L. Assessment of value of calibrated lyophilized plasmas to determine International Sensitivity Index for coagulometers. J Clin Pathol 1992; 45: 58-60
6 Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The value of plasma calibrants in correcting coagulometer effects on International Normalized Ratios. Am J Clin Path 1995; 103 (03) 358-365
7 WHO Expert Committee on Biological Standardisation. 33rd Report, WHO Technical Series 1983; 687: 81-105
8 Thomson JM, Tomenson JA, Poller L. The calibration of the second International Reference Preparation for thromboplastin (thromboplastin human plain, coded BCT/253). Thromb Haemost 1984; 52: 336-342
9 Hermans J, Besselaar AMHP Van den, Loeliger EA, Velde EA Van der. A collaborative calibration study of reference materials for thromboplastins. Thromb Haemost 1983; 50: 712-717
10 van den Besselaar AMHP. Multicentre study of replacement of the International Reference Preparation for thromboplastin rabbit plain. Thromb Haemost 1993; 70: 794-799
11 van den Besselaar AMHP. The use of lyophilized calibration plasmas and control blood for INR calculation on external quality control of the prothrombin time. Am J Clin Path 1995; 102: 123-127
12 Poller L, Tabemer DA, Thomson JM, Morris J, Mibashan RS, Shinton NK. The effect of the choice of WHO IRP for thromboplastin on INR. J Clin Pathol 1993; 46: 64-66
13 van den Besselaar AMHP, Bertina RM. Multicenter study of thromboplastin calibration. Precision - Influence of reagent species, composition and international sensitivity index. Thromb Haemost 1993; 69: 35-40
14 Thomson JM, Darby KV, Poller L. Calibration of BCT/441, the ICSH reference preparation for thromboplastin. Thromb Haemost 1986; 55: 379-382
15 Tomenson JA. A statistician’s independent evaluation. In: Thromboplastin calibration and oral anticoagulation Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Martinus Nijhoff; Boston: 1984: 87-108
16 Van der Velde EA. Orthogonal regression equation. In: Thromboplastin calibration and oral anticoagulation Van den Besselaar AMHP, Gralnick HR, Lewis SM. eds Martinus Nijhoff; Boston: 1984: 25-40
17 Tripodi A, Chantarangkul V, Braga M, Poller L, ten Cate JW, Van den Besselaar AMHP, Mannucci PM. Results of a multicentre study assessing the status of standardization of a recombinant thromboplastin for the control of oral anticoagulant therapy. Thromb Haemost 1994; 72 (02) 261-267
18 Tripodi A, Poller L, van den Besselaar AMHP, Mannucci PM. A proposed scheme for calibration of International Reference Preparation of thromboplastin for the prothrombin time. Thromb Haemost 1995; 74 (05) 1368-1369