Subscribe to RSS
DOI: 10.1055/s-0038-1661209
The Calibration of the Second Primary International Reference Preparation for Thromboplastin (Thromboplastin, Human, Plain, Coded BCT/253)
Publication History
Received 25 May 1984
Accepted 03 October 1984
Publication Date:
19 July 2018 (online)
Summary
An international collaborative exercise has been undertaken to calibrate a replacement for the first WHO primary international reference preparation (IRP) for thromboplastin. The replacement preparation is a lyophilised batch of British Comparative Thromboplastin (BCT/253, human plain) for use in the Quick prothrombin time test. Seventeen centres participated. The experimental design, calibration model and statistical analysis were based on the recommended WHO procedure. As a result of this calibration exercise an International Sensitivity Index (ISI) of 1.1 has been assigned to the preparation by WHO and it has been officially recognised as the second primary IRP for thromboplastin.
The calibration of BCT/253 is an essential link in a new hierarchical structure for the standardisation of the prothrombin time. The aim is to provide a uniform international system of reporting prothrombin time results using International Normalised Ratios (INR) derived from the ISI of individual thromboplastins.
-
References
- 1 Ingram GI C. The stability of the WHO reference thromboplastin NIBS and C 67/40. Thromb Haemostas 1979; 42: 1135-1140
- 2 Hills M, Ingram GI C. Monitoring successive batches of British Comparative Thromboplastin. Br J Haematol 1973; 25: 334-451
- 3 Bailey EI, Harper TA, Pinkerton PH. The “therapeutic range” of the one-stage prothrombin time in the control of anticoagulant therapy: the effect of different thromboplastin preparations. Can Med Ass J 1971; 105: 1041-1044
- 4 Bain B, Forster T, Sleigh B. Control of oral anticoagulants by the prothrombin time: a plea for uniformity. Aust J Med 1978; 2: 459-461
- 5 Bradlow BA, Saunder C, Whitbread P, Lurie A, Penfold GK, Metz J. Standardisation of the laboratory control of anticoagulant therapy. S A Med J 1974; 48: 1857-1862
- 6 Brink S, Cloete H, Roberts R, Holm W. Laboratoriumsstandaar- disasie en kwaliteitskontrole in Antistolterapie. S A Med J 1976; 50: 205-208
- 7 Korsan-Bengtsen K, Johsen M, Pehrsson NG. Comparison between British Comparative Thromboplastin (BCT) and a factor II-VII-X determination method (Simplastin A) based on fresh plasma samples from dicoumarol-treated patients. Thromb Haemostas 1977; 37: 98-103
- 8 Talalak P. Current oral anticoagulant practice and its laboratory control in Thailand: II. Comparison of rabbit brain and human brain thromboplastin, calibration against standard reference thromboplastin. J Med Ass Thai 1979; 62: 618-629
- 9 Tankovski I, Lisichkov T, Angelova TS V, Buchvarova V. Study of the standardized Bulgarian thromboplastin for prothrombin time determination. Contemp Med 1977; 28: 40-43
- 10 Zucker S, Brosious E, Cooper GR. One-stage prothrombin time survey. Am J Clin Pathol 1970; 53: 340-347
- 11 WHO Expert Committee on Biological Standardisation. 34th Report. WHO Technical Report Series; 1983. 700 19
- 12 Loeliger EA, van den Besselaar AM H P, Hermans J, van der Velde EA. Certification of three reference materials for thromboplastins. BCR Information. Commission of the European Communities. Brussels: 1981
- 13 Hermans J, van den Besselaar AM H P, Loeliger EA, van der Velde EA. A collaborative calibration study of reference materials for thromboplastins. Thromb Haemostas 1983; 50: 712-717
- 14 WHO Expert Committee on Biological Standardisation. 33rd Report. WHO Technical Report Series; 1983. 687 81-105
- 15 Kirkwood TB L. Calibration of reference thromboplastins and standardisation of the prothrombin time ratio. Thromb Haemostas 1983; 49: 238-244
- 16 Kendall MG, Stuart A. The Advanced Theory of Statistics. Charles Griffin; London: 1972. 2 391-435
- 17 Tomenson JA. A statistician’s independent evaluation. In: Van den Besselaar AM H P, Gralnick HR, Lewis SM. (eds) Thromboplastin Calibration and Oral Anticoagulant Control. Martinus Nijhoff; The Hague: 1984. pp 87-108
- 18 Poller L, Thomson JM, Yee KF. Stability studies on lyophilized reference thromboplastins for standardisation of prothrombin times. Lancet 1977; 2: 1019-1022
- 19 Van den Besselaar AM H P, Van Halem-Visser LP, Loeliger EA, Hermans J. Stability of international reference thromboplastins. Br J Haematol 1980; 45: 153-160
- 20 Stevenson KJ, Slater PJ, Poller L. The British Comparative Thromboplastin: The relationship between lipid class composition and procoagulant activity. Br J Haematol 1980; 44: 495-501