Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination

Journal of Thrombosis and Haemostasis

Volumn 2, Issue 11, 2004, Pages 1946-1953

  van den Besselaar, A M H P ^g   Barrowcliffe, T W ^a   Houbouyan Reveillard L L ^b   Jespersen, J ^c   Johnston, M ^d   Poller, L ^e   Tripodi, A ^f  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b HÔPITAL AMBROISE PARÉ   (France)

^c UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^d HAMILTON HEALTH SCIENCES   (Canada)

^e UNIVERSITY OF MANCHESTER   (United Kingdom)

^f UNIVERSITY OF MILAN   (Italy)

^g LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Anticoagulant control; International normalized ratio; International sensitivity index; Prothrombin time; Thromboplastin

Indexed keywords

FRESH FROZEN PLASMA; THROMBOPLASTIN;

ARTICLE; CALIBRATION; CERTIFICATION; CORRELATION FUNCTION; FREEZE DRYING; INTERNATIONAL NORMALIZED RATIO; LABORATORY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTHROMBIN TIME; QUALITY CONTROL; REFERENCE VALUE; RELIABILITY; SCREENING TEST; STANDARDIZATION; VALIDATION PROCESS; WORLD HEALTH ORGANIZATION;

CALIBRATION; HUMANS; INTERNATIONAL NORMALIZED RATIO; METHODS; PLASMA; PROTHROMBIN TIME; REFERENCE STANDARDS; THROMBOPLASTIN;

EID: 13244265499     PISSN: 15387933     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2004.00970.x     Document Type: Article

References (48)

1. WHO. WHO Expert Committee on Biological Standardization Guidelines for Thromboplastins and Plasma Used to Control Oral Anticoagulant Therapy. WHO Technical Report Series no. 889. Geneva: WHO, 1999: 64-93.
2. WHO Expert Committee on Biological Standardization. Thirty-third Report. Requirements for Thromboplastins and Plasma Used to Control Oral Anticoagulant Therapy. WHO Technical Report Series no. 687. Geneva: WHO, 1983: 81-105.
3. Kirkwood TBL. Calibration of reference thromboplastins and standardisation of the prothrombin time ratio. Thromb Haemost 1983; 49: 238-44.
4. Poggio M, van den Besselaar AMHP, van der Velde EA, Bertina RM. The effect of some instruments for prothrombin time testing on the international sensitivity index (ISI) of two rabbit tissue thromboplastin reagents. Thromb Haemost 1989; 62: 868-74.
5. Peters RHM, van den Besselaar AMHP, Olthuis FMFG. A multicentre study to evaluate method dependency of the international sensitivity index of bovine thromboplastin. Thromb Haemost 1989; 61: 166-9.
6. Ray MJ, Smith IR. The dependence of the international sensitivity index on the coagulometer used to perform the prothrombin time. Thromb Haemost 1990; 63: 424-9.
7. Van den Besselaar AMHP, Houbouyan LL, Aillaud MF, Denson KWE, Johnston M, Kitchen S, Lindahl TL, Marren M, Martinuzzo ME, Droulle C, Tripodi A, Vergnes C. Influence of three types of automated coagulometers on the international sensitivity index (ISI) of rabbit, human, and recombinant human tissue factor preparations. A multicenter study. Thromb Haemost 1999; 81: 66-70.
8. Clarke K, Taberner DA, Thomson JM, Morris JA, Poller L. Assessment of value of calibrated lyophilised plasmas to determine international sensitivity index for coagulometers. J Clin Pathol 1992; 45: 58-60.
9. Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. A simplified statistical method for local INR using linear regression. Br J Haematol 1997; 98: 640-7.
10. Poller L, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. A comparison of artificially-depleted, lyophilized coumarin and fresh coumarin plasmas in thromboplastin calibration. Br J Haematol 1998; 101: 462-7.
11. Poller L, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. The European Concerted Action on Anticoagulation (ECAA): Field studies of coagulometer effects on the ISI of ECAA thromboplastins. Thromh Haemost 1998; 80: 615-23.
12. Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The value of plasma calibrants in correcting coagulometer effect on International Normalized Ratios. An international multicenter study. Am J Clin Pathol 1995; 103: 358-65.
13. Poller L, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. Correction for lack of coincidence of normal and abnormal calibration slopes in ISI determination. Thromb Haemost 1999; 81 935-9.
14. Tomenson JA. A statistician's independent evaluation. In: Van den Besselaar AMHP Gralnick HR Lewis SM, eds. Thromboplastin Calibration and Oral Anticoagulant Control, Chapter 5. The Hague: Martinus-Nijhoff Publishers, 1984: 87-108.
15. Hubbard AR, Margetts SML, Barrowcliffe TW. International normalized ratio determination using calibrated reference plasmas. Br J Haematol 1997; 98: 74-8.
16. Houbouyan L, Goguel AF. Long term French experience in INR standardization by a procedure using plasma calibrants. Am J Clin Pathol 1997; 108: 83-9.
17. Kitchen S, Jennings I, Woods TAL, Preston FE. Local calibration of international normalised ratio improves between laboratory agreement: results from the UK national external quality assessment scheme. Thromb Haemost 1999; 81: 60-5.
18. Brien WF, Baskerville JC, Taberner DA, Crawford L. Calculation vs calibration curve for INR determination. Results of an interlaboratory proficiency scheme. Am J Clin Pathol 1999; 111: 193-201.
19. Van den Besselaar AMHP. Field study of lyophilised plasmas for local prothrombin time calibration in the Netherlands. J Clin Pathol 1997; 50: 371-4.
20. Adcock DM, Duff S. Enhanced standardization of the international normalized ratio through the use of plasma calibrants: a concise review. Blood Coagul Fibrinolysis 2000; 11: 583-90.
21. Adcock DM, Johnston M. Evaluation of frozen plasma calibrants for enhanced standardization of the international normalized ratio (INR): a multi-center study. Thromb Haemost 2002; 87: 74-9.
22. van den Besselaar AMHP, Houbouyan-Reveillard LL. Field study of lyophilised calibrant plasmas for fresh plasma INR determination. Thromb Haemost 2002; 87: 277-81.
23. van den Besselaar AMHP, Houbouyan-Reveillard LL, Aillaud MF, Denson KWE, Droulle C, Johnston M, Kitchen S, Lindahl TL, Marren M, Martinuzzo ME, Tripodi A, Vergnes C. Multicenter evaluation of lyophilized and deep-frozen plasmas for assignment of the International Normalized Ratio. Thromb Haemost 1999; 82: 1451-5.
24. Chantarangkul V, Tripodi A, Cesana BM, Mannucci PM. Calibration of local systems with lyophilized calibrant plasmas improves the interlaboratory variability of the INR in the Italian external quality assessment scheme. Thromb Haemost 1999; 82: 1621-6.
25. Van den Besselaar AMHP. Comparison of lyophilized plasmas with fresh plasmas for calibration of thromboplastin reagents in oral anticoagulant control. Br J Haematol 1996; 93: 437-44.
26. Stevenson KJ, Craig S, Dufty JMK, Taberner DA. System ISI calibration: a universally applicable scheme is possible only when coumarin plasma calibrants are used. Br J Haematol 1997; 96: 435-41.
27. Fairweather RB, Ansell J, van den Besselaar AMHP, Brandt JT, Bussey HL Poller L, Triplett DA, White RH. College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy. Laboratory monitoring of oral anticoagulant therapy. Arch Pathol Lab Med 1998; 122: 768-81.
28. Goodman L, Sidebotham JA, Taberner DA. Sensitivity of thromboplastins to freezing- and freeze drying-induced alterations in coumarin plasmas. Blood Coagul Fibrinolysis 1996; 7: 733-4.
29. Sidebotham JA, Goodman LJ, Taberner DA. The effects of freezing and freeze drying on coagulation factors of the extrinsic pathway. Blood Coagul Fibrinolysis 1996; 7: 734.
30. Tripodi A, Chantarangkul V, Akkawat B, Clerici M, Mannucci PM. A partial factor V deficiency in anticoagulated lyophilized plasmas has been identified as a cause of the international normalized ratio discrepancy in the external quality assessment scheme. Thromb Res 1995; 78:283-92.
31. Poller L, Keown M, Shepherd SA, Shiach CR, Tabeart S. The effects of freeze drying additives on the prothrombin time and the international sensitivity index. J Clin Pathol 1999; 52: 744-8.
32. Adcock DM, Kressin DC, Marlar RA. Effect of 3.2% vs 3.8% sodium citrate concentration on routine coagulation testing. Am J Clin Pathol 1997; 107: 105-10.
33. Duncan EM, Casey CR, Duncan BM, Lloyd JV. Effect of concentration of trisodium citrate anticoagulant on the calculation of the international normalised ratio and the international sensitivity index of thromboplastin. Thromb Haemost 1994; 72: 84-8.
34. Chantarangkul V, Tripodi A, Clerici M, Negri B, Mannucci PM. Assessment of the influence of citrate concentration on the international normalized ratio (INR) determined with twelve reagent-instrument combinations. Thromb Haemost 1998; 80: 258-62.
35. Van den Besselaar AMHP, Chantarangkul V, Tripodi A. A comparison of two sodium citrate concentrations in two evacuated blood collection systems for prothrombin time and ISI determination. Thromb Haemost 2000; 84: 664-7.
36. Lottin L, Woodhams BJ, Saureau MC, Robert A, Aillaud MF, Arnaud E, Martinoli JL. The clinical relevance of the citrate effect on international normalized ratio determinations depends on the reagent and instrument combination used. Blood Coagul Fibrinolysis 2001; 12 399-404.
37. Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. European Concerted Action on Anticoagulation. Minimum lyophilized plasma requirement for ISI calibration. Am J Clin Pathol 1998; 109: 196-204.
38. Van den Besselaar AMHP, Witteveen E, Schaefer-van Mansfeld H, van Rijn C, van der Meer FJM. Effect of plasma pooling on the international sensitivity index of prothrombin time systems. Blood Coagul Fibrinolysis 1998; 9: 645-51.
39. Tripodi A, Chantarangkul V, Manotti C, Poggi M, Braga M, Akkawat B, Bucciarelli P, Mannucci PM. A simplified procedure for thromboplastin calibration. The usefulness of lyophilized plasmas assessed in a collaborative study. Thromb Haemost 1996; 75: 309-12.
40. Van den Besselaar AMHP. Multi-center study of replacement of the international reference preparation for thromboplastin, rabbit, plain. Thromb Haemost 1993; 70: 794-9.
41. Hubbard AR, Margetts SML, Weller LJ, Macnab J, Barrowcliffe TW. An international collaborative study on the INR calibration of freeze-dried reference plasmas. Br J Haematol 1999; 104: 455-60.
42. Dufty JMK, Craig S, Stevenson KJ, Taberner DA. Calculation of system international sensitivity index: how many calibrant plasmas are required? J Clin Pathol 1997; 50: 40-4.
43. Critchfield GC, Bennett ST, Swaim WR. Calibration verification of the international normalized ratio. Am J Clin Pathol 1996; 106: 781-94.
44. Finney DJ. Calibration of thromboplastins. Proc R Soc Lond B 1995; 262: 71-5.
45. Van der Velde EA. Orthogonal regression equation. In: Van den Besselaar AMHP, Gralnick HR, Lewis SM, eds. Thromboplastin Calibration and Oral Anticoagulant Control, Chapter 3. The Hague: Martinus-Nijhoff Publishers, 1984: 25-39.
46. Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet 1995; 346: 1085-7.
47. Poller L. Screening INR deviation of local prothrombin time systems. J Clin Pathol 1998; 51: 356-9.
48. Van den Besselaar AMHP, Meeuwisse-Braun J, Witteveen E, van Meegen E. Effect of evacuated blood collection tubes on thromboplastin calibration. Thromb Haemost 1998; 79: 1062-3.