Performance goals for the laboratory testing of antithrombin protein C and protein S

Thrombosis and Haemostasis

Volumn 96, Issue 5, 2006, Pages 584-589

  Meijer, Piet ^a,b   Haverkate, Frits ^a   Kluft, Cornelis ^a  

^a ECAT Foundation   (Netherlands)

^b NONE   (Netherlands)

Author keywords

Analytical performance; EQA; Long term; Thrombophilia

Indexed keywords

ANTITHROMBIN; PROTEIN C; PROTEIN S;

ACCURACY; ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; DIAGNOSTIC TEST; HUMAN; LABORATORY TEST; MODEL; PRIORITY JOURNAL; PROTEIN DETERMINATION; PROTEIN FUNCTION; QUALITY CONTROL;

ANTITHROMBIN III; BIAS (EPIDEMIOLOGY); DRUG MONITORING; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; PROTEIN C; PROTEIN S; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS;

EID: 33751209473     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH06-07-0404     Document Type: Article

References (44)

1. Lane DA, Mannucci PM, Bauer K, Bertina RM, Bochkov NP, Boulyjenkov V, et al. Inherited Thrombophilia: Part I. Thromb Haemost 1996; 76: 651-62.
2. Lane DA, Mannucci PM, Bauer K, et al. Inherited Thrombophilia: Part II. Thromb Haemost 1996; 76: 824-34.
3. Michiels JJ, Hamulyák K. Laboratory diagnosis of hereditary thrombophilia. Sem Thromb Haemostas 1998; 24: 309-19.
4. De Moerloose Ph, Bounameaux HR, Mannucci PM. Screening tests for thrombophilic patients: which tests, for which patient, by whom, when and why? Sem Thromb Haemostas 1998; 24: 321-7.
5. Walker ID, Greaves M, Preston FE. Investigation and management of heritable thrombophilia. Br J Haematol 2001; 114: 512-28.
6. Libeer JC, Baadenhuijsen H, Fraser GC, et al. Characterisation and classification of external quality assessment schemes (EQA) according to objectives such as evaluation of method and participant bias and standard deviation. Eur J Clin Chem Clin Biochem 1996; 34: 665-78.
7. Hyltoft Petersen P, Ricós C, Stöckl D, et al. Proposed guidelines for internal quality control of analytical results in the medical laboratory. Eur J Clin Chem Clin Biochem 1996; 34: 983-99.
8. Groth T, De Verdier CH. Transferability of clinical laboratory data. Upsala J Med Sci 1993; 98: 259-74.
9. Büttner J. Reference materials and reference methods in laboratory medicine: a challenge to international co-operation. Eur J Clin Chem Clin Biochem 1994; 32: 571-7.
10. Ehrmeyer SS, Laessig RH. Alternative statistical approach to evaluating interlaboratory performance. Clin Chem 1985; 31: 106-8.
11. Fraser CG, Hyltoft Petersen P. Desirable standards for laboratory tests if they are to fulfil medical needs. Clin Chem 1993; 39: 1447 55.
12. Doumas BT. The evaluation and limitations of accuracy and precision standards. Clin Chim Acta 1997; 260: 145-62.
13. Meijer P, De Maat MPM, Kluft C, et al. Assessment of the long-term analytical performance of field methods in haemostasis by evaluation of results of an external quality assessment programme. Clin Chem 2002; 48: 1011-5.
14. Meijer P, Kluft C, Haverkate F, et al. The long-term within- and between-laboratory variability for assay of antihrombin, and proteins C and S: results derived from the external quality assessment program for thrombophilia screening of the ECAT Foundation. J Thromb Haemost 2003; 1: 748-53.
15. Stöckl D, Baadenhuijsen H, Fraser CG, et al. Desirable routine analytical goals for quantities assayed in serum. Eur J Clin Chem Clin Biochem 1995; 33: 157-69.
16. Fraser CG. General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest 1999; 59: 487-90.
17. Cotlove E, Harris EK, Williams GZ. Components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medical implications, Clin Chem 1970; 16: 1028-32.
18. Harris EK. Statistical principles underlying analytical goal-setting in clinical chemistry. Am J Clin Pathol 1979; 72: 364-82.
19. Gowans EMS, Hyltoft Petersen P, Blaabjerg O, et al. Analytical goals for the acceptance of common reference intervals for laboratories throughout a geographical area. Scand J Clin Lab Invest 1988; 48: 757 64.
20. Fraser CG, Hyltoft Petersen P, Lytken Larsen M. Setting analytical goals for random analytical error in specific clinical monitoring situations. Clin Chem 1990; 36: 1625-8.
21. Fuentes-Arderiu X, Fraser CG. Analytical goals for interference. Ann Clin Biochem 1991; 28: 393-5.
22. Fraser CG, Hyltoft Petersen P, Ricos C, et al. Proposed quality specifications for the imprecision and inaccuracy of analytical systems for clinical chemistry. Eur J Clin Chem Clin Biochem 1992; 30: 311-7.
23. Klee GG. Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity. Clin Chem 1993; 39: 1514-8.
24. Fraser CG, Hyltoft Petersen P, Libeer JC, et al. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997; 34: 8-12.
25. Mina A. A new quality control model using performance goals based on biological variation in external quality assurance schemes. Clin Chem Lab Med 2006; 44: 86-91.
26. Costongs GMPJ, Bas BM, Janson PCW. Short-term and long-term intra-individual variations and critical differences of coagulation parameters. J Clin Chem Clin Biochem, 1985; 23: 405-10.
27. Thompson SG, Martin JC, Meade TW. Sources of variability in coagulation factor assays. Thromb Haemost 1987; 58: 1073-7.
28. Chambless LE, McMahon R, Wu KK, et al. Short-term intra-individual variability in hemostasis factors. The ARIC study. Ann Epidemiol 1992; 2: 723-33.
29. Nguyen ND, Ghaddar H, Stinson V, et al. ARIC Hemostasis Study-IV Intra-individual variability and reliability of hemostatic factors. Thromb Haemost 1995; 73: 256-60.
30. Marckmann P, Sandström B, Jespersen J. The variability of and associations between measures of blood coagulation, fibrinolysis and blood lipids. Atherosclerosis 1992; 96: 235-44.
31. Blombäck M, Eneroth P, Landgren BM, et al. On the intraindividual and gender variability of haemostatic components. Thromb Haemost 1992; 67: 70-5.
32. Dot D, Miró J, Fuentes-Arderiu X. Within-subject and between-subject biological variation of prothrombin tune and activated partial thromboplastin time. Ann Clin Biochem 1992; 29: 422-5.
33. De Maat MPM, de Bart ACW, Hennis BC, et al. Interindividual and intraindividual variability in plasma fibirnogen, tPA antigen, PAI activity, and CRP in healthy, young volunteers and patients with angina pectoris. Atheros Thromb Vasc Biol 1996; 16: 1156-62.
34. Salomaa V, Rasi V, Stengård J, et al. Intra- and inter-individual variability of hemostatic factors and traditional cardiovascular risk factors in a three-year follow-up. Thromb Haemost 1998; 79: 969-74.
35. Riese H, Vrijkotte TGM, Meijer P, et al. Covariance of metabolic and haemostatic risk indicators in men and women. Fibrinol Proteol 2001; 14: 1-12.
36. Ricós C, Alvarez V, Cava F, et al. Current database on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491-500.
37. Database on biological variation at Westgard website: Available at http://www.westgard.com/biodatabasel.htm.
38. Thompson SG, Duckert F, Haverkate F. The measurement of haemostatic factors in 16 European laboratories. Quality assessment for the multicentre ECAT Angina Pectoris Study. Thromb Haemost 1989; 61: 301-6.
39. Haverkate F, Walker ID, Conkie J. External quality assessment of thrombophilia testing in Europe. Fibrinolysis 1996; 10 (Suppl 2): 169.
40. Meijer P, Haverkate E. External quality assessment and the laboratory diagnosis of thrombophilia. Semin Thromb Hemost 2005; 31: 59-65.
41. Kirkwood TBL, Barrowcliffe TW, Thomas DP. An international collaborative study establishing a reference preparation for antithrombin III. Thromb Haemost 1980; 43: 10-5.
42. Hubbard AR. Standardization of protein C in plasma: establishment of an international standard. Thromb Haemost 1988; 59: 464-67.
43. Hubbard AR. Standardization of protein S in plasma: calibration of the 1st international standard. Thromb Haemost 1997; 78: 1237-41.
44. Bertina RM. Protein S antigen. In: Laboratory Techniques in Thrombosis. A manual, 2nd revised edition of ECAT Assay Procedures. Dordrecht: Kluwer Academic Publishers, 1999: 141-51.