Download PDF
Thromb Haemost 1998; 80(04): 615-623
DOI: 10.1055/s-0037-1615432
Rapid Communication
Schattauer GmbH

The European Concerted Action on Anticoagulation (ECAA): Field Studies of Coagulometer Effects on the ISI of ECAA Thromboplastins

L. Poller
1   From the Central Facility, ECAA, The University of Manchester, UK
,
A. M. H. P. van den Besselaar
2   From the Haemostasis and Thrombosis Research Centre, Leiden University Medical Centre, NL
,
J. Jespersen
3   From the Department of Clinical Biochemistry, Centralsygehuset, Esbjerg, DK
,
A. Tripodi
4   From the A Bianchi Bonomi, Hemophilia and Thrombosis Centre, University & IRCCS Maggiore Hospital, Milan, IT
,
D. Houghton
1   From the Central Facility, ECAA, The University of Manchester, UK
,
› Author Affiliations
Further Information

Publication History

Received 27 January 1998

Accepted after revision 05 June 1998

Publication Date:
08 December 2017 (online)

    Permissions and Reprints

Summary

Local calibration studies have been performed with lyophilized plasmas at 155 European laboratories to assess coagulometer effects on manual ISI of ECAA thromboplastins (low ISI human recombinant and high ISI rabbit brain). Common sets of 7 normal and 20 artificially depleted lyophilized plasmas were tested with the thromboplastins in the routine local coagulometers. With the human reagent, marked lowering of the manual ISI resulted with most coagulometers, which was associated with disproportionate shortening of the normals. Where this shortening did not occur, there was little coagulometer effect on the ISI. With the rabbit reagent, proportionate shortening with both normal and abnormal plasmas occurred in most instruments with little effect on ISI. INR correction by local ISI assignment appeared successful with the ECAA human reagent. There was negligible INR correction from local calibration of the ECAA rabbit reagent in coagulometers where thromboplastin ISI were unchanged from the ECAA established manual values.

 

  • 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: 321-8.
    CrossrefPubMedGoogle Scholar
  • 2 Poller L, Thomson JM, Taberner DA. Effect of automation on the prothrombin time test in NEQAS surveys. J Clin Pathol 1989; 42: 97-100.
    CrossrefPubMedGoogle Scholar
  • 3 van Rijn JLML, Schmidt Nico A, 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: 840-3.
    PubMedGoogle Scholar
  • 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: 424-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 5 Clarke K, Taberner 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.
    CrossrefPubMedGoogle Scholar
  • 6 Poller L, Triplett DA, Hirsh J, Carroll J, Clarke K. The Value of Plasmas Calibrants in Correcting Coagulometer Effects on International Normalized Ratios – An International Multicenter Study. Am J Clin Pathol 1995; 103: 358-65.
    CrossrefPubMedGoogle Scholar
  • 7 van den Besselaar AMHP. Comparison of lyophilized plasmas with fresh plasmas for calibration of thromboplastin reagents in oral anticoagulant control. Brit J Haemat 1996; 93: 437-44.
    CrossrefPubMedGoogle Scholar
  • 8 European Concerted Action on Anticoagulation (ECAA).. 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. Brit J Haemat 1998; 101: 462-7.
    CrossrefPubMedGoogle Scholar
  • 9 Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. European Concerted Action on Anticoagulation (ECAA). The Multicentre Calibration of Rabbit and Human ECAA Reference Thromboplastins. Thromb Haemost 1996; 76: 977-82.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 10 Poller L, Barrowcliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. The European Concerted Action on Anticoagulation (ECAA) Evaluation of a set of lyophilized normal plasmas to establish the normal prothrombin time for coagulometer systems. Thromb Haemost 1998; 79: 122-8.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 11 Poller L, Taberner DA, Thomson JM, Morris J, Mibashan RS, Shinton NK. Effect of the choice of WHO international reference preparation for thromboplastin on international normalized ratios. J Clin Pathol 1993; 46: 64-6.
    CrossrefPubMedGoogle Scholar
  • 12 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.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Tripodi A, Poller L, van den Besselaar AMHP, Mannucci PM. ISHT Scientific and Standardisation Committee Communications. On behalf of the Sub-committee on Control of Anticoagulation. A proposed scheme for calibration of International Reference Preparations of thromboplastin for the prothrombin time. Thromb Haemost 1995; (a) 74: 1368-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 14 Thomson JM, Darby KV, Poller L. Calibration of BCT/441, the ICSH reference preparation for thromboplastin. Thromb Haemost 1986; 55: 379-82.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 15 WHO Expert Committee on Biological Standardisation.. 33rd Report, WHO Technical Series. 1983 687. 81-105.
    PubMedGoogle Scholar
  • 16 Thomson JM. A practical guide to blood coagulation and hemostasis. London: Churchill Livingstone; 1970: 178-9.
    Google Scholar
  • 17 Clauss A. Gerinnungsphysiologische Schnellmethode zur Bestimmung des Fibrinogens. Acta Haemat 1957; 17: 237-46.
    CrossrefPubMedGoogle Scholar
  • 18 Tripodi A, Chantarangul V, Akkawat B, Clerici M, Mannucci PM. A partial factor V deficiency in anticoagulated lyophilized plasmas was identified as a cause of the International Normalized Ratio discrepancy in External Quality Assessment Scheme. Thromb Res 1995; (b) 78-283.
    PubMedGoogle Scholar
  • 19 Kirkwood TBL. Calibration of reference thromboplastins and standardisation of the prothrombin time ratio. Thromb Haemost 1983; 49: 238-44.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 20 van der Velde EA, Orthogonal regression equation. In van den Besselaar AMHP, Gralnick HR, Lewis SM. (eds). Thromboplastin calibration and oral anticoagulation. Boston: Martinus Nijhoff; 1984: 25-40.
    Google Scholar
  • 21 Tomenson JA, A statistician’s independent evaluation. In van den Besselaar AMHP, Gralnick HR, Lewis SM. (eds). Thromboplastin calibration and oral anticoagulation. Boston: Martinus Nijhoff; 1984: 87-108.
    Google Scholar
  • 22 Kitchen S, Walker ID, Woods TAL, Preston FE. Thromboplastin related differences in the determination of International Normalised Ratio: A cause for concern?. Thromb Haemost 1994; 72: 426-9.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 23 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.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 24 Poller L, Thomson JM, Taberner DA, Clarke DK. The correction of coagulometer effects on international normalized ratios: A multicentre evaluation. Brit J Haemat 1994; 86: 112-7.
    CrossrefPubMedGoogle Scholar
  • 25 Hirsh J, Dalen JE, Deykin D, Poller L, Bussey H. Oral Anticoagulants: Mechanism of Action, Clinical Effectiveness, and Optimal Therapeutic Range. CHEST supplement 1995; 108: 231S-46S.
    PubMedGoogle Scholar
  • 26 European Concerted Action on Anticoagulation (ECAA).. Poller L, Barrow-cliffe TW, van den Besselaar AMHP, Jespersen J, Tripodi A, Houghton D. Minimum Lyophilized Plasma Requirement for ISI Calibration. Am J Clin Pathol 1998; 109: 196-204.
    CrossrefPubMedGoogle Scholar
  • 27 Poller L, Houghton D, Carroll J. The reliability of the mean normal prothrombin time of fresh plasmas and of the normal value from a lyophilized “normal” plasma in prothrombin ratio determination. Brit J Haemat 1994; 88: 866-73.
    CrossrefPubMedGoogle Scholar