Laboratory criteria for antiphospholipid syndrome: communication from the SSC of the ISTH

Journal of Thrombosis and Haemostasis

Volumn 16, Issue 4, 2018, Pages 809-813

  Devreese, K M J ^a   Ortel, T L ^b   Pengo, V ^c   de Laat, B ^d,e  

^a GHENT UNIVERSITY HOSPITAL   (Belgium)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF PADOVA   (Italy)

^d MAASTRICHT UNIVERSITY   (Netherlands)

^e Synapse BV   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BETA2 GLYCOPROTEIN 1 ANTIBODY; CARDIOLIPIN ANTIBODY; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; LUPUS ANTICOAGULANT; PHOSPHOLIPID ANTIBODY; BETA2 GLYCOPROTEIN 1; BIOLOGICAL MARKER;

ANTIBODY DETECTION; ANTIPHOSPHOLIPID SYNDROME; ARTICLE; DIAGNOSTIC VALUE; DISEASE ASSOCIATION; ENZYME LINKED IMMUNOSORBENT ASSAY; HIGH RISK PATIENT; HUMAN; LABORATORY TEST; PRIORITY JOURNAL; QUALITY CONTROL; REPEAT PROCEDURE; RISK FACTOR; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; THROMBOSIS; BLOOD; BLOOD EXAMINATION; CONSENSUS; IMMUNOLOGY; PRACTICE GUIDELINE; PREDICTIVE VALUE; REPRODUCIBILITY; STANDARDS;

ANTIBODIES, ANTICARDIOLIPIN; ANTIBODIES, ANTIPHOSPHOLIPID; ANTIPHOSPHOLIPID SYNDROME; BETA 2-GLYCOPROTEIN I; BIOMARKERS; CONSENSUS; HEMATOLOGIC TESTS; HUMANS; LUPUS COAGULATION INHIBITOR; PREDICTIVE VALUE OF TESTS; REPRODUCIBILITY OF RESULTS;

EID: 85043491393     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.13976     Document Type: Article

References (49)

1. Miyakis S, Lockshin MD, Atsumi T, Branch DW, Brey RL, Cervera R, Derksen RH, De Groot PG, Koike T, Meroni PL, Reber G, Shoenfeld Y, Tincani A, Vlachoyiannopoulos PG, Krilis SA. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost 2006; 4: 295–306.
2. Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, Galli M, De Groot PG. Update of the guidelines for lupus anticoagulant detection. Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2009; 7: 1737–40.
3. Devreese KM, Pierangeli SS, de Laat B, Tripodi A, Atsumi T, Ortel TL; Subcommittee on Lupus Anticoagulant/Phospholipid/Dependent Antibodies. Subcommittee on Lupus Anticoagulant/Phospholipid/Dependent A. Testing for antiphospholipid antibodies with solid phase assays: guidance from the SSC of the ISTH. J Thromb Haemost 2014;12:792–5.
4. Galli M, Luciani D, Bertolini G, Barbui T. Lupus anticoagulants are stronger risk factors for thrombosis than anticardiolipin antibodies in the antiphospholipid syndrome: a systematic review of the literature. Blood 2003; 101: 1827–32.
5. Devreese KM. Antiphospholipid antibodies: evaluation of the thrombotic risk. Thromb Res 2012; 130(Suppl 1): S37–40.
6. Pengo V, Testa S, Martinelli I, Ghirarduzzi A, Legnani C, Gresele P, Passamonti SM, Bison E, Denas G, Jose SP, Banzato A, Ruffatti A. Incidence of a first thromboembolic event in carriers of isolated lupus anticoagulant. Thromb Res 2015; 135: 46–9.
7. Devreese KM. Antiphospholipid antibody testing and standardization. Int J Lab Hematol 2014; 36: 352–63.
8. Devreese K, Hoylaerts MF. Laboratory diagnosis of the antiphospholipid syndrome: a plethora of obstacles to overcome. Eur J Haematol 2009; 83: 1–16.
9. Devreese K, Peerlinck K, Hoylaerts MF. Thrombotic risk assessment in the antiphospholipid syndrome requires more than the quantification of lupus anticoagulants. Blood 2010; 115: 870–8.
10. Zuily S, Ait Aissa K, Membre A, Regnault V, Lecompte T, Wahl D. Thrombin generation in antiphospholipid syndrome. Lupus 2012; 21: 758–60.
11. deMoerloose P, Reber G, Musial J, Arnout J. Analytical and clinical performance of a new, automated assay panel for the diagnosis of antiphospholipid syndrome. J Thromb Haemost 2010; 8: 1540–6.
12. Gutensohn K, Vossen D, Strate A, Kersten JF, Hofbauer M, Krieger T. Automated, semi-automated, and manual analyses of anti-cardiolipin and anti-beta2-glycoprotein I antibodies in women with a history of miscarriage. Int J Lab Hematol 2013; 35: 150–62.
13. Persijn L, Decavele AS, Schouwers S, Devreese K. Evaluation of a new set of automated chemiluminescense assays for anticardiolipin and anti-beta2-glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome. Thromb Res 2011; 128: 565–9.
14. Senant M, Rostane H, Fernani-Oukil F, Hosking F, Bellery F, Courchinoux A, Tartour E, Darnige L, Dragon-Durey MA. Increased performances of the biological diagnosis of the antiphospholipid syndrome by the use of a multiplex assay. J Immunol Res 2015; 2015: 983094.
15. Tozzoli R, Villalta D. Autoantibody profiling of patients with antiphospholipid syndrome using an automated multiplexed immunoassay system. Autoimmun Rev 2014; 13: 59–63.
16. Van Hoecke F, Persijn L, Decavele AS, Devreese K. Performance of two new, automated chemiluminescence assay panels for anticardiolipin and anti-beta2-glycoprotein I antibodies in the laboratory diagnosis of the antiphospholipid syndrome. Int J Lab Hematol 2012; 34: 630–40.
17. Devreese KM, Poncet A, Lindhoff-Last E, Musial J, de Moerloose P, Fontana P. A multicenter study to assess the reproducibility of antiphospholipid antibody results produced by an automated system. J Thromb Haemost 2017; 15: 91–5.
18. Pierangeli SS, Harris EN. A protocol for determination of anticardiolipin antibodies by ELISA. Nat Protoc 2008; 3: 840–8.
19. Gardiner C, Hills J, Machin SJ, Cohen H. Diagnosis of antiphospholipid syndrome in routine clinical practice. Lupus 2013; 22: 18–25.
20. Devreese K, Peerlinck K, Hoylaerts MF. Diagnostic test combinations associated with thrombosis in lupus anticoagulant positive patients. Thromb Haemost 2011; 105: 736–8.
21. Favaloro EJ, Wheatland L, Jovanovich S, Roberts-Thomson P, Wong RC. Internal quality control and external quality assurance in testing for antiphospholipid antibodies: Part I–Anticardiolipin and anti-beta2-glycoprotein I antibodies. Semin Thromb Hemost 2012; 38: 390–403.
22. Pelkmans L, Kelchtermans H, de Groot PG, Zuily S, Regnault V, Wahl D, Pengo V, de Laat B. Variability in exposure of epitope G40-R43 of domain i in commercial anti-beta2-glycoprotein I IgG ELISAs. PLoS ONE 2013; 8: e71402.
23. Devreese K, Kelchtermans H, de Laat B. Differences in sensitivity of two automated panels for anticardiolipin and anti-beta2glycoprotein I antibodies in the laboratory diagnosis of antiphospholipid syndrome due to the exposure of the domain I epitope of beta2glycoprotein I on the solid phase. J Thromb Haemost 2014; 12: 55.
24. Galli M, Borrelli G, Jacobsen EM, Marfisi RM, Finazzi G, Marchioli R, Wisloff F, Marziali S, Morboeuf O, Barbui T. Clinical significance of different antiphospholipid antibodies in the WAPS (warfarin in the antiphospholipid syndrome) study. Blood 2007; 110: 1178–83.
25. Kelchtermans H, Pelkmans L, de Laat B, Devreese KM. IgG/IgM antiphospholipid antibodies present in the classification criteria for the antiphospholipid syndrome: a critical review of their association with thrombosis. J Thromb Haemost 2016; 14: 1530–48.
26. Pengo V, Banzato A, Bison E, Bracco A, Denas G, Ruffatti A. What have we learned about antiphospholipid syndrome from patients and antiphospholipid carrier cohorts? Semin Thromb Hemost 2012; 38: 322–7.
27. Arachchillage DR, Machin SJ, Mackie IJ, Cohen H. Diagnosis and management of non-criteria obstetric antiphospholipid syndrome. Thromb Haemost 2015; 113: 13–9.
28. Ruffatti A, Olivieri S, Tonello M, Bortolati M, Bison E, Salvan E, Facchinetti M, Pengo V. Influence of different IgG anticardiolipin antibody cut-off values on antiphospholipid syndrome classification. J Thromb Haemost 2008; 6: 1693–6.
29. Pengo V, Biasiolo A, Pegoraro C, Cucchini U, Noventa F, Iliceto S. Antibody profiles for the diagnosis of antiphospholipid syndrome. Thromb Haemost 2005; 93: 1147–52.
30. Ruffatti A, Tonello M, Del Ross T, Cavazzana A, Grava C, Noventa F, Tona F, Iliceto S, Pengo V. Antibody profile and clinical course in primary antiphospholipid syndrome with pregnancy morbidity. Thromb Haemost 2006; 96: 337–41.
31. Pengo V, Ruffatti A, Legnani C, Gresele P, Barcellona D, Erba N, Testa S, Marongiu F, Bison E, Denas G, Banzato A, Padayattil Jose S, Iliceto S. Clinical course of high-risk patients diagnosed with antiphospholipid syndrome. J Thromb Haemost 2010; 8: 237–42.
32. Pengo V, Ruffatti A, Legnani C, Testa S, Fierro T, Marongiu F, De Micheli V, Gresele P, Tonello M, Ghirarduzzi A, Bison E, Denas G, Banzato A, Padayattil Jose S, Iliceto S. Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: a multicenter prospective study. Blood 2011; 118: 4714–8.
33. Mustonen P, Lehtonen KV, Javela K, Puurunen M. Persistent antiphospholipid antibody (aPL) in asymptomatic carriers as a risk factor for future thrombotic events: a nationwide prospective study. Lupus 2014; 23: 1468–76.
34. Pengo V, Biasiolo A, Bison E, Chantarangkul V, Tripodi A; Italian Federation of Anticoagulation Clinics (FCSA). Antiphospholipid antibody ELISAs: survey on the performance of clinical laboratories assessed by using lyophilized affinity-purified IgG with anticardiolipin and anti-beta2-Glycoprotein I activity. Thromb Res 2007; 120: 127–33.
35. Urbanus RT, Siegerink B, Roest M, Rosendaal FR, de Groot PG, Algra A. Antiphospholipid antibodies and risk of myocardial infarction and ischaemic stroke in young women in the RATIO study: a case-control study. Lancet Neurol 2009; 8: 998–1005.
36. Buyon JP, Kim MY, Guerra MM, Laskin CA, Petri M, Lockshin MD, Sammaritano L, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Garabet L, Salmon JE. Predictors of pregnancy outcomes in patients with lupus: a cohort study. Ann Intern Med 2015; 163: 153–63.
37. Iwaniec T, Kaczor MP, Celinska-Lowenhoff M, Polanski S, Musial J. Identification of patients with triple antiphospholipid antibody positivity is platform and method independent. Pol Arch Med Wewn 2016; 126: 19–24.
38. Pengo V. Four good reasons to appreciate triple positivity. Pol Arch Med Wewn 2016; 126: 7–8.
39. de Laat B, Derksen RH, Urbanus RT, de Groot PG. IgG antibodies that recognize epitope Gly40-Arg43 in domain I of beta 2-glycoprotein I cause LAC, and their presence correlates strongly with thrombosis. Blood 2005; 105: 1540–5.
40. de Laat B, Pengo V, Pabinger I, Musial J, Voskuyl AE, Bultink IE, Ruffatti A, Rozman B, Kveder T, de Moerloose P, Boehlen F, Rand J, Ulcova-Gallova Z, Mertens K, de Groot PG. The association between circulating antibodies against domain I of beta2-glycoprotein I and thrombosis: an international multicenter study. J Thromb Haemost 2009; 7: 1767–73.
41. Mahler M, Albesa R, Zohoury N, Bertolaccini ML, Ateka-Barrutia O, Rodriguez-Garcia JL, Norman GL, Khamashta M. Autoantibodies to domain 1 of beta 2 glycoprotein I determined using a novel chemiluminescence immunoassay demonstrate association with thrombosis in patients with antiphospholipid syndrome. Lupus 2016; 25: 911–6.
42. De Craemer AS, Musial J, Devreese KM. Role of anti-domain 1-beta2 glycoprotein I antibodies in the diagnosis and risk stratification of antiphospholipid syndrome. J Thromb Haemost 2016; 14: 1779–87.
43. Pengo V, Ruffatti A, Tonello M, Cuffaro S, Banzato A, Bison E, Denas G, Padayattil Jose S. Antiphospholipid syndrome: antibodies to Domain 1 of beta2-glycoprotein 1 correctly classify patients at risk. J Thromb Haemost 2015; 13: 782–7.
44. Meneghel L, Ruffatti A, Gavasso S, Tonello M, Mattia E, Spiezia L, Tormene D, Hoxha A, Fedrigo M, Simioni P. Detection of IgG anti-Domain I beta2 Glycoprotein I antibodies by chemiluminescence immunoassay in primary antiphospholipid syndrome. Clin Chim Acta 2015; 446: 201–5.
45. Iwaniec T, Kaczor MP, Celinska-Lowenhoff M, Polanski S, Musial J. Clinical significance of anti-domain 1 beta2-glycoprotein I antibodies in antiphospholipid syndrome. Thromb Res 2017; 153: 90–4.
46. Pengo V, Ruffatti A, Tonello M, Hoxha A, Bison E, Denas G, Padayattil Jose S, Zoppellaro G, Bracco A, Banzato A. Antibodies to Domain 4/5 (Dm4/5) of beta2-Glycoprotein 1 (beta2GP1) in different antiphospholipid (aPL) antibody profiles. Thromb Res 2015; 136: 161–3.
47. Sciascia S, Sanna G, Murru V, Roccatello D, Khamashta MA, Bertolaccini ML. Anti-prothrombin (aPT) and anti-phosphatidylserine/prothrombin (aPS/PT) antibodies and the risk of thrombosis in the antiphospholipid syndrome. A systematic review. Thromb Haemost 2014; 111: 354–64.
48. Hoxha A, Mattia E, Tonello M, Grava C, Pengo V, Ruffatti A. Antiphosphatidylserine/prothrombin antibodies as biomarkers to identify severe primary antiphospholipid syndrome. Clin Chem Lab Med 2017; 55: 890–8.
49. Pengo V, Ruffatti A, Del Ross T, Tonello M, Cuffaro S, Hoxha A, Banzato A, Bison E, Denas G, Bracco A, Padayattil Jose S. Confirmation of initial antiphospholipid antibody positivity depends on the antiphospholipid antibody profile. J Thromb Haemost 2013; 11: 1527–31.