A new chromogenic assay (HemosIL ThromboPath) is sensitive to major prothrombotic risk factors affecting the protein C pathway. Results of a multicenter study

Thrombosis Research

Volumn 124, Issue 1, 2009, Pages 137-143

  Toulon, Pierre ^a,b   Smirnov, Mikhail ^c   Triscott, Mark ^c   Safa, Omid ^c   Biguzzi, Eugenia ^d   Bouziane, Kader ^b   Tripodi, Armando ^d  

^a UNIVERSITÉ CÔTE D'AZUR   (France)

^b Hematology Department ^*  (France)

^c Instrumentation Laboratory   (United States)

^d FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

Author keywords

Factor V Leiden; Global assay; Lupus anticoagulant; Protein C; Protein S; Screening; Thromboembolism

Indexed keywords

BLOOD CLOTTING FACTOR 5 LEIDEN; LUPUS ANTICOAGULANT; PROTEIN C; PROTHROMBIN; REAGENT;

ARTICLE; HEMOSIL THROMBOPATH; HUMAN; LABORATORY TEST; METHODOLOGY; PLASMA; PREDICTOR VARIABLE; PRIORITY JOURNAL; PROTEIN C DEFICIENCY; RECEIVER OPERATING CHARACTERISTIC; REFERENCE VALUE; RETROSPECTIVE STUDY; RISK FACTOR; SENSITIVITY AND SPECIFICITY;

BIOLOGICAL ASSAY; CASE-CONTROL STUDIES; EVALUATION STUDIES AS TOPIC; FACTOR V; FIBRINOLYTIC AGENTS; HETEROZYGOTE; HUMANS; MULTICENTER STUDIES AS TOPIC; MUTATION; PEPTIDES; PROTEIN C; REAGENT KITS, DIAGNOSTIC; RETROSPECTIVE STUDIES; RISK FACTORS; SENSITIVITY AND SPECIFICITY; THROMBOSIS; VENOUS THROMBOEMBOLISM;

EID: 64649096469     PISSN: 00493848     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.thromres.2008.11.017     Document Type: Article

References (42)

1. De Stefano V., Finazzi G., and Mannucci P.M. Inherited thrombophilia: pathogenesis, clinical syndromes, and management. Blood 87 (1996) 3531-3544
2. Lane D.A., Mannucci P.M., Bauer K.A., Bertina R.M., Bochkov N.P., Boulyjenkov V., et al. Inherited thrombophilia. Part 1. Thromb Haemost 76 (1996) 651-662
3. Seligsohn U., and Lubetsky A. Genetic susceptibility to venous thrombosis. N Engl J Med 344 (2001) 1222-1231
4. Lane D.A., Mannucci P.M., Bauer K.A., Bertina R.M., Bochkov N.P., Boulyjenkov V., et al. Inherited thrombophilia. Part 2. Thromb Haemost 76 (1996) 824-834
5. Esmon N.L., Smirnov M.D., and Esmon C.T. Lupus anticoagulants and thrombosis: the role of phospholipids. Haematologica 82 (1997) 474-477
6. Aznar J., Villa P., Espana F., Estellés A., Grancha S., and Falco C. Activated protein C resistance phenotype in patients with antiphospholipid antibodies. J Lab Clin Med 130 (1997) 202-208
7. Gardiner C., Cohen H., Jenkins A., Machin S.J., and Mackie I.J. Detection of acquired resistance to activated protein C associated with antiphospholipid antibodies using a novel clotting assay. Blood Coag Fibrinol 17 (2006) 477-483
8. Liestol S., Sandset P.M., Mowinckel M.C., and Wisloff F. Activated protein C resistance determined with a thrombin generation-based test is associated with thrombotic events in patients with lupus anticoagulants. J Thromb Haemost 5 (2007) 2204-2210
9. Duchemin J., Pittet J.L., Tartary M., Béguin S., Gaussem P., Alhenc-Gelas M., et al. A new assay based on thrombin generation inhibition to detect both protein C and protein S deficiencies in plasma. Thromb Haemost 71 (1994) 331-338
10. Kraus M., Noah M., and Fickenscher K. The PCAT- a simple screening assay for assessing the functionality of the protein C anticoagulant pathway. Thromb Res 79 (1995) 217-222
11. Denson K.W.E., Haddon M.E., Reed S.V., Davidson S., and Littlewood T.J. A more discriminating test for APC resistance and a possible screening test to include protein C and protein S. Thromb Res 81 (1996) 151-156
12. Robert A., Eschwege V., Hameg H., Drouet L., and Aillaud M.F. Anticoagulant response to Agkistrodon Contortrix Venom (ACV) test: a new global test to screen for defects in the anticoagulant protein C pathway. Thromb Haemost 75 (1996) 562-566
13. Preda L., Simioni P., Legnani C., Palareti G., Poggio M., Rossi E., et al. A new global test for the evaluation of the protein C-protein S system. Blood Coagul Fibrinolysis 7 (1996) 465-469
14. ®-based screening test for activated protein C-resistant factor Va and other defects of the protein C anticoagulant pathway. Blood Coagul Fibrinolysis 8 (1997) 327-335
15. Haas F.J.L.M., van Sterkenburg-Kamp B.M., and Scheepers H.A.M.M. A protein C pathway (PCP) screening test for the detection of APC resistance and protein C or S deficiencies. Semin Thromb Hemost 24 (1998) 355-362
16. Toulon P., Perez P., Demay Y., and Dornon O. Screening for abnormalities of the protein C anticoagulant pathway using the Protein C Pathway Test. Fibrinolysis Proteolysis 13 S.1 (1999) 21-25
17. Bertina R.M., Koeleman B.P.C., Koster T., Rosendaal F.R., Dirven R.J., De Ronde H., et al. Mutation in blood coagulation factor V associated with resistance to activated protein C. Nature 369 (1994) 64-67
18. Brandt J.T., Triplett D.A., Alving B., and Scharrer I. Criteria for the diagnosis of lupus anticoagulants: an update. Thromb Haemost 74 (1995) 1185-1190
19. Metz C.E. Basic principles of ROC analysis. Semin Nucl Med 8 (1978) 283-298
20. ® Global: the first functional screening assay for the complete protein C pathway. Clin Chem 43 (1997) 1719-1723
21. ® Global for identification of defects in the protein C/protein S anticoagulant pathway. Thromb Res 87 (1997) 501-510
22. Gemmati D., Serino M.L., and Scapoli G.L. A modified functional global test to measure protein C, protein S activities and the activated protein C-resistance phenotype. Thromb Res 92 (1998) 141-148
23. Tripodi A., Akhavan S., Asti D., Faioni E.M., and Mannucci P.M. Laboratory screening of thrombophilia. Evaluation of the diagnostic efficacy of a global test to detect congenital deficiencies of the protein C anticoagulant pathway. Blood Coagul Fibrinolysis 9 (1998) 485-489
24. Toulon P., Halbmeyer W.M., Hafner G., Schmitt Y., Randgard B., Odpadlik M., et al. Screening for abnormalities of the protein C anticoagulant pathway using the ProC Global assay. Results of a European multicenter trial. Blood Coagul Fibrinolysis 11 (2000) 447-454
25. ® Global assay for protein C pathway abnormalities. Clinical experience in 899 unselected patients with venous thromboembolism. Thromb Res 104 (2001) 93-103
26. Gardiner C., Cooper P.C., Makris M., Mackie I.J., Malia R.G., and Machin S.J. An evaluation of screening tests for defects in the protein C pathway: commercial kits lack sensitivity and specificity. Blood Coagul Fibrinolysis. 13 (2002) 155-163
27. Kraus M. The anticoagulant potential of the protein C system in hereditary and acquired thrombophilia: pathomechanisms and new tools for assessing its clinical relevance. Semin Thromb Hemost 24 (1998) 337-354
28. Toulon P., Adda R., and Perez P. Economic impact of the introduction of the ProC Global assay in the screening strategy of protein C pathway abnormalities in unselected patients with a history of venous thromboembolism. Thromb Haemost 86 (2001) 720-721
29. Rosén S., et al., for the APC resistance study group. Multicenter evaluation of a kit for activated protein C resistance on various coagulation instruments using plasmas from healthy individuals. Thromb Haemost 72 (1994) 255-260
30. Toulon P., Lequerrec A., Piquet P., Robert A., and Biron C. Significant influence of the instrument on the result of the ProC Global assay. A multicenter evaluation using lyophilized plasmas and frozen plasma samples from carriers and non-carriers of the factor V Leiden mutation. Thromb Res 107 (2002) 181-188
31. Toulon P., and Bouziane K. Analytical performance of a new screening assay to evaluate the functionality of the protein C anticoagulant pathway, and effect of pre-analytical variables on the test result. J Thromb Haemost 3 Suppl.1 (2005) P0691 (Abstract)
32. Koster T., Blann A.D., Briët E., Vandenbroucke J.P., and Rosendaal F.R. Role of clotting factor VIII in effect of von Willebrand factor on occurrence of deep-vein thrombosis. Lancet 345 (1995) 152-155
33. Poort S.R., Rosendaal F.R., Reitsma P.H., and Bertina R.M. A common genetic variation in the 3'-untranslated region of the prothrombin gene is associated with elevated plasma prothrombin levels and an increased risk of venous thrombosis. Blood 88 (1996) 3698-3703
34. Howard T.E., Viel K., Channell C., and Duncan A. Coordinate expression of elevated prothrombin and factor X levels; a potential novel mechanism of thrombophilia. Thromb Haemost 82 (1999) 542 (Suppl) (Abstract)
35. Meijers J.C.M., Tekelenburg W.L.H., Bouma B.N., Bertina R.M., and Rosendaal F.R. High levels of factor XI as a risk factor for venous thrombosis. N Engl J Med 342 (2000) 696-701
36. Smirnov M.D., Safa O., Esmon N.L., and Esmon C.T. Inhibition of APC anticoagulant activity by prothrombin. Blood 94 (1999) 3839-3846
37. Tripodi A., Chantarangkul V., and Mannucci P.M. Hyperprothrombinemia may result in acquired activated protein C resistance. Blood 96 (2000) 3295-3296
38. Toulon P., Rosencher N., Guigon A., and Simon A. Sensitivity of a new global assay for protein C (PC) pathway abnormalities and potential significance of an abnormal test result as a risk factor/marker for thrombosis independently of its sensitivity for PC pathway abnormalities. Blood 106 (2005) 740a (Abstract)
39. Grand'Maison A., Bates S.M., Johnston M., McRae S., and Ginsberg J.S. "ProC Global": a functional screening test that predicts recurrent venous thromboembolism. Thromb Haemost 93 (2005) 600-604
40. Sarig G., Aberbach I., Schliamser L., Blumenfeld Z., and Brenner B. Evaluation of ProC Global assay in women with a history of venous thromboembolism on hormonal therapy. Thromb Haemost 96 (2006) 578-583
41. Toulon P., Perez P., Rapp J., and Adda R. An abnormal ProC Global test result is associated with an increased risk of venous thromboembolism independent of test sensitivity for protein C pathway abnormalities. Thromb Haemost 98 (2007) 228-233
42. Eichinger S., Hron G., Hirschl M., Bialonczyk C., Minar E., Kollars M., et al. Prediction of recurrent venous thromboembolism by measuring ProC Global. Thromb Haemost 98 (2007) 1232-1236