Thromb Haemost 1989; 61(02): 301-306
DOI: 10.1055/s-0038-1646581
Original Article
Schattauer GmbH Stuttgart

The Measurement of Haemostatic Factors in 16 European Laboratories: Quality Assessment for the Multicentre ECAT Angina Pectoris Study

Report from the European Concerted Action on Thrombosis and Disabilities (EGAT)
S G Thompson
1   The Clinical Trials Research Unit, Dept. of Clinical Epidemiology and General Practice, Royal Free Hospital Medical School, London, UK
,
F Duckert
2   The Gerinnungslabor, Kantonsspital, Basle, Switzerland
,
F Haverkate
3   The Gaubius Institute TNO3, Leiden, The Netherlands
,
J M Thomson
4   The UK Reference Laboratory for Anticoagulant Reagents and Controla, Manchester, UK
› Author Affiliations
Further Information

Publication History

Received 04 November 1987

Accepted after revision 02 January 1989

Publication Date:
24 July 2018 (online)

Summary

As part of a European multicentre prospective study involving the measurement of a number of haemostatic factors, a quality assessment (QA) scheme was organized. This paper describes the preparation, design and results of the first Qa exercise, involving 16 European laboratories and 10 haemostatic assays. The design allowed the investigation, for each assay, of the variability between duplicates and the variability between days within each centre, and of the agreement between centres. A graphical presentation of each centre’s performance in comparison to that of others was adopted, which preserved the confidentiality of each centre’s results. The factor VIII clotting activity assay (VIII: C) and the rocket immuno-electrophoresis assays of von Willebrand factor related antigen (vWF R:Ag), antithrombin III, protein C and histidine-rich glycoprotein showed the highest betweenduplicate and between-day coefficients of variation (CVs), whereas the clotting assays of activated partial thromboplastin time and fibrinogen had the lowest CVs. CVs for the enzymatic assays using synthetic substrates of antithrombin III, plasminogen and alpha-2-antiplasmin were between these extremes. The between-centre CVs were high for both the VIII:C and vWFR:Ag assays. The QA exercise showed that, in multicentre studies involving the measurement of haemostatic factors, it is feasible to undertake analysis locally at each centre.

 
  • References

  • 1 Meade TW, Brozovic M, Chakrabarti RR, Haines AP, Imeson JD, Mellows S, Miller GG, North WR S, Stirling Y, Thompson SG. Haemostatic function and ischaemic heart disease: principal results of the Northwick Park Heart Study. Lancet 1986; 2: 533-577
  • 2 Wilhclmsen L, Svaerdsudd K, Korsan-Bengsten K, Larson B, Welin L, Tibblin G. Fibrinogen as a risk factor for stroke and myocardial infarction. New Engl J Med 1984; 311: 501-505
  • 3 Kannel WB, D’Agostino RB, Belanger AJ. Fibrinogen, cigarette smoking, and risk of cardiovascular disease: Insights from the Framingham Study. Am Heart J 1987; 113: 1006-1010
  • 4 Balleisen L, Schulte H, Assman G, Epping PP, van de Loo J. Coagulation factors and the progress of coronary heart disease. Lancet 1987; 2: 461
  • 5 North WR S, Stirling Y, Meade TW. Variation between batches in clotting factor assays. Thromb Haemostas 1982; 48: 274-278
  • 6 BMDP Statistical Software. Program 3S. Dixon WJ. (ed) University of California Press; Los Angeles, CA: 1981
  • 7 Poller L. Quality control in blood coagulation. In: Thomson JM. (ed) Blood Coagulation and Haemostasis: A Practical Guide. Churchill Livingstone; Edinburgh: 1980. pp 331-359
  • 8 Whitehead TP, Woodford FP. External quality assessment of clinical laboratories in the United Kingdom. J Clin Pathol 1981; 34: 947-957
  • 9 European Committee for Clinical Laboratory Standards. ECCLS Document, Vol2, No 1. 1985. Springer-Verlag; Berlin:
  • 10 Mannucci PM, Mariana G, Tentori L. (eds) Standardization and quality control of coagulation tests. Scand J Haematol 1980 25. Suppl 37
  • 11 Triplett DA. (ed) Standardization of Coagulation Assays: An Overview. College of American Pathologists; Skokie, IL: 1982
  • 12 Tabemer DA. The scope and organization of the NEQAS in blood coagulation. In: Quality Assurance and Control in Clinical Laboratories Institute of Medical Laboratory Sciences 1984; pp 133-141
  • 13 Poller L. Achievements of the NEQAS in blood coagulation. In: Quality Assurance and Control in Clinical Laboratories. Institute of Medical Laboratory Sciences 1984; pp 142-151
  • 14 Poller L. The international program of external quality assessment in blood coagulation. In: Triplett DA. (ed) Advances in Coagulation Testing: Interpretation and Application. College of American Pathologists; Skokie, IL: 1985. pp 289-298
  • 15 Thomson JM. Grading of performance of factor VIII :C assays in external quality assessment programs. In: Triplett DA. (ed) Advances in Coagulation Testing: Interpretation and Application. College of American Pathologists; Skokie, IL: 1985. pp 87-90