Validation protocol of analytical hemostasis systems: Measurement of anti-Xa activity of low-molecular-weight heparins

Clinical Chemistry

Volumn 42, Issue 8, 1996, Pages 1223-1230

  Houbouyan, L ^a   Boutiere, B ^a   Contant, G ^a   Dautzenberg, M D ^a   Fievet, P ^a   Potron, G ^a   Vassault, A ^a   Gourmelin, Y ^a  

^a HÔPITAL AMBROISE PARÉ   (France)

Author keywords

anti factor Xa; hemostasis; standardization

Indexed keywords

LOW MOLECULAR WEIGHT HEPARIN;

ARTICLE; CALIBRATION; CLINICAL TRIAL; CONTAMINATION; DIAGNOSTIC ACCURACY; FREEZE DRYING; HEMOSTASIS; HUMAN; HUMAN CELL; HUMAN TISSUE; MULTICENTER STUDY; REPRODUCIBILITY;

EID: 0029742588     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinchem/42.8.1223     Document Type: Article

References (32)

1. Vassault A, Grafmeyer D, Naudin CI, Dumont G, Bailly M, Henny J, et al. Protocole de validation de techniques. Ann Biol Clin 1986; 44:686-745.
2. Tietz NW. A model for a comprehensive measurement system. Clin Chem 1979; 25:833-9.
3. Drewinko F, Roe E, Hasler D, Wallace B, Johnston D. Evaluation of automatic and semi-automatic coagulation assay instruments. Clin Lab Haematol 1980; 2:215-26.
4. Kennedy DA, working party. Tentative protocol for the evaluation of coagulometers, based on one-stage prothrombin time. Clin Lab Haematol 1981; 3:71-6.
5. Barrowcliffe TW, Johnson EA, Thomas DP. Low molecular weight heparin. Chichester, UK: J Wiley and Sons, 1992: 203pp.
6. Fareed J, Walenga JM. Automation in coagulation testing: part 2. Semin Thromb Hemost 1983; 9:235-9.
7. Walenga JM. Practical issues on the laboratory monitoring of low molecular weight heparins and related polysaccharides. Semin Thromb Hemost 1993; 19(Suppl 1):69-72.
8. Abildgaard U, Norrheim L, Larsen AE, Nesvold A, Sandset PM, Odegaard OR. Monitoring therapy with LMW heparin: a comparison of three chromogenic substrate assays and the Heptest clotting assays. Haemostasis 1990; 20:193-203.
9. Yin ET, Wessler S, Burtier JV. Plasma heparin: a unique, practical, submicrogram sensitive assay. J Lab Clin Med 1973; 81:298-310.
10. Houbouyan LL, Goguel AF. Evaluation comparative des héparines non fractionnées et de bas poids moléculaire: résultats du contrôle de qualité Interlaboratoire Français Etalonorme. Ann Biol Clin 1993; 2:109-17.
11. Roncato M, de Prost D, Folléa G, Potron G, Aïach M et les Membres de la Commission "Nouvelles Méthodes en Hémostase" de la SFBC. Proposition de recommandation pour la mesure de l'activité biologique de l'héparine dans le plasma. Inf Sci Biol 1985; 11:418-20.
12. Sie P, Aillaud MF, de Prost D, Droullé C, Forestier F, Guedj P, et al. Measurement of low molecular weight heparin ex vivo activities in clinical laboratories using various anti-Xa assays: interlaboratory variability and requirements for an agreed low molecular weight heparin standard. Thromb Haemost 1987; 58:879-83.
13. Teien A, Lie M, Abildgaard U. Assay of heparin in plasma using a chromogenic substrate for activated factor X. Thromb Res 1976; 8:413-6.
14. Aiach M, Roncato M. Practical considerations on the measurement of low molecular weight heparin anti-Xa activity. Semin Thromb Hemost 1985; 11:108-11.
15. Anderson DJ. Determination of the lower limit of detection [Letter]. Clin Chem 1989; 35:2152-3.
16. Naudin CL, Vassault A, Truchaud A, Members of "Instrumentation" Commission of the SFBC. Protocol for the study of carry-over on chemistry analyzers. Ann Biol Clin 1988; 46:215-6.
17. Ozawa T, Mamman EF. LMW heparin (anti-Xa) assays for clinical monitoring and pharmacokinetic studies on the automated coagulation laboratory (ACL). Thromb Res 1992; 66:287-98.
18. Pili-Truc J, Mas JC. Evaluation d'un analyseur d'hémostase, le ST 888 pour les techniques chronométriques et colorimétriques. Feuill Biol 1990; 31:59-62.
19. Dati F, Becker U, Hissung A, Keller F. New perspectives in diagnosis of hemostasis disorders. Ann Biol Clin 1988; 46:201-10.
20. Barrowcliffe TW, Curtis AD, Thomas DP. An international standard for low molecular weight heparin. Thromb Haemost 1988; 60:1-7.
21. Contant G, Gouault-Heilmann M, Martinoli JL. Heparin inactivation during blood storage: its prevention by blood collection in citric acid, theophylline, adenosine, dipyridamole - "C.T.A.D. mixture." Thromb Res 1983; 31:365-74.
22. Blanc JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1:307-10.
23. Aiach M. Should deep venous thrombosis treatment with LMWH (Fragmin) be monitored or not? Results of a randomized comparative multicentric French study. Thromb Haemost 1991; 6:754.
24. Lensing AWA, Prins MH, Davidson BL, Hirsh J. Treatment of deep venous thrombosis with low-molecular-weight heparins: a metaanalysis. Arch Intern Med 1995; 155:601-7.
25. Levine MN, Hirsh J. An overview of clinical trials of LMWH fractions. Acta Chir Scand 1988; 543(Suppl):73-9.
26. Barrowcliffe TW. Low molecular weight heparin(s). Br J Haematol 1995; 90:1-7.
27. Marci CD, Prager D. A review of the clinical indications for the plasma heparin assay. Am J Clin Pathol 1993; 99:546-50.
28. Levine M, Planes A, Hirsh J, Goodyear M, Vochelle N, Gent M. The relationship between antifactor Xa level and clinical outcome in patients receiving low molecular weight enoxaparine to prevent deep vein thrombosis after hip replacement. Thromb Haemost 1989; 62:940-4.
29. Baadenhuijsen H, Demacker PNM, Hessels M, Boerma GJM, Penders TJ, Weykamp C, Willems HL. Testing the accuracy of total cholesterol assays in an external quality control program: effect of adding sucrose to lyophilized control sera compared with use of fresh or frozen sera. Clin Chem 1995; 41:724-30.
30. Ferrero CA, Carobene A, Ceriotti F, Modenese A, Arcelloni C. Behavior of frozen serum pools and lyophilized sera in an external quality-assessment scheme. Clin Chem 1995; 41:575-80.
31. NCCLS. Evaluation protocols: user evaluation of precision performance of clinical chemistry devices, Vol. 4. Villanova, PA: National Committee for Clinical Laboratory Standards, 1989:188-9.
32. Walenga JM, Fareed J. Automation and quality control in the coagulation laboratory. Clin Lab Med 1994; 14:709-28