Internal quality control and external quality assurance in testing for antiphospholipid antibodies: Part I-anticardiolipin and anti-glycoprotein i antibodies

Seminars in Thrombosis and Hemostasis

Volumn 38, Issue 4, 2012, Pages 390-403

  Favaloro, Emmanuel J ^a   Wheatland, Loretta ^b   Jovanovich, Sue ^b   Roberts Thomson, Peter ^b   Wong, Richard C W ^c  

^a WESTMEAD HOSPITAL   (Australia)

^b FLINDERS MEDICAL CENTRE   (Australia)

^c ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

Author keywords

anti glycoprotein I antibodies; anticardiolipin antibodies; antiphospholipid antibodies; antiphospholipid syndrome; external quality assurance; internal quality control; proficiency testing

Indexed keywords

ANTI BETA 2 GLYCOPROTEIN 1 ANTIBODY; CARDIOLIPIN ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; PHOSPHOLIPID ANTIBODY; UNCLASSIFIED DRUG;

CLINICAL ASSESSMENT; CONSENSUS; DIAGNOSTIC KIT; EXTERNAL QUALITY ASSURANCE; HUMAN; IMMUNOASSAY; INTERNAL QUALITY CONTROL; LABORATORY TEST; PERFORMANCE MEASUREMENT SYSTEM; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROVOCATION TEST; QUALITY CONTROL; REVIEW; STANDARDIZATION;

ANTIBODIES, ANTICARDIOLIPIN; ANTIBODIES, ANTIPHOSPHOLIPID; BETA 2-GLYCOPROTEIN I; FEMALE; HUMANS; PREGNANCY; PREGNANCY COMPLICATIONS; QUALITY ASSURANCE, HEALTH CARE; QUALITY CONTROL;

EID: 84861339453     PISSN: 00946176     EISSN: 10989064     Source Type: Journal    
DOI: 10.1055/s-0032-1311990     Document Type: Review

References (35)

1. Asherson RA. The primary, secondary, catastrophic, and seronegative variants of the antiphospholipid syndrome: a personal history long in the making. Semin Thromb Hemost: 2008; 34 3 227 235
2. Harris EN, Pierangeli SS. Primary, secondary, and catastrophic antiphospholipid syndrome: what's in a name? Semin Thromb Hemost: 2008; 34 3 219 226
3. Favaloro EJ, Wong RCW. The antiphospholipid syndrome: a large elephant with many parts or an elusive chameleon disguised by many colours? Autoimmunity Highlights: 2010; 1 5 14
4. Favaloro EJ, Wong RC. Laboratory testing for the antiphospholipid syndrome: making sense of antiphospholipid antibody assays. Clin Chem Lab Med: 2011; 49 3 447 461
5. Miyakis S, Lockshin MD, Atsumi T., et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost: 2006; 4 2 295 306
6. Pengo V, Tripodi A, Reber G., et al. Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis Update of the guidelines for lupus anticoagulant detection. J Thromb Haemost: 2009; 7 10 1737 1740
7. 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 5 1827 1832 (Pubitemid 36237580)
8. Galli M, Luciani D, Bertolini G, Barbui T. Anti-beta 2-glycoprotein I, antiprothrombin antibodies, and the risk of thrombosis in the antiphospholipid syndrome. Blood: 2003; 102 8 2717 2723 (Pubitemid 37248837)
9. Greco TP, Amos MD, Conti-Kelly AM, Naranjo JD, Ijdo JW. Testing for the antiphospholipid syndrome: importance of IgA anti-beta 2-glycoprotein I. Lupus: 2000; 9 1 33 41 (Pubitemid 30265116)
10. Lakos G, Kiss E, Regczy N., et al. Isotype distribution and clinical relevance of anti-beta2-glycoprotein I (beta2-GPI) antibodies: importance of IgA isotype. Clin Exp Immunol: 1999; 117 3 574 579 (Pubitemid 29398308)
11. Yamada H, Tsutsumi A, Ichikawa K, Kato EH, Koike T, Fujimoto S. IgA-class anti-beta2-glycoprotein I in women with unexplained recurrent spontaneous abortion. Arthritis Rheum: 1999; 42 12 2727 2728 (Pubitemid 30327198)
12. Kumar S, Papalardo E, Sunkureddi P, Najam S, Gonzlez EB, Pierangeli SS. Isolated elevation of IgA anti-beta2glycoprotein I antibodies with manifestations of antiphospholipid syndrome: a case series of five patients. Lupus: 2009; 18 11 1011 1014
13. Favaloro EJ, Wong RC. Laboratory testing and identification of antiphospholipid antibodies and the antiphospholipid syndrome: a potpourri of problems, a compilation of possible solutions. Semin Thromb Hemost: 2008; 34 4 389 410
14. Favaloro EJ, Wong RCW. Current clinical and laboratory practice for the investigation of the antiphospholipid syndrome: findings from the 2008 Australasian antiphospholipid antibody survey. Pathology: 2009; 41 7 666 675
15. Bonar R, Favaloro EJ, Adcock D. Quality in coagulation and haemostasis testing. Biochem Med: 2010; 20 2 184 199
16. Favaloro EJ, Bonar R, Marsden K. Internal quality control and external quality assurance in testing for antiphospholipid antibodies: part IIlupus anticoagulant. Semin Thromb Hemost: 2012; 38 4 404 411
17. Wong RCW, Gillis D, Adelstein S., et al. Consensus guidelines on anti-cardiolipin antibody testing and reporting. Pathology: 2004; 36 1 63 68 (Pubitemid 38223415)
18. Wong RC, Favaloro EJ, Adelstein S., et al. Consensus guidelines on anti-beta 2 glycoprotein I testing and reporting. Pathology: 2008; 40 1 58 63 (Pubitemid 350172955)
19. Wong RC, Adelstein S, Gillis D, Favaloro EJ. Development of consensus guidelines for anticardiolipin and lupus anticoagulant testing. Semin Thromb Hemost: 2005; 31 1 39 48 (Pubitemid 40262136)
20. Lakos G, Favaloro EJ, Harris EN., et al. International consensus guidelines on anticardiolipin and anti-2-glycoprotein I testing: report from the 13th International Congress on Antiphospholipid Antibodies. Arthritis Rheum: 2012; 64 1 1 10
21. Favaloro EJ, Silvestrini R, Mohammed A. Clinical utility of anticardiolipin antibody assays: high inter-laboratory variation and limited consensus by participants of external quality assurance programs signals a cautious approach. Pathology: 1999; 31 2 142 147 (Pubitemid 29264060)
22. Favaloro EJ, Silvestrini R. Assessing the usefulness of anticardiolipin antibody assays: a cautious approach is suggested by high variation and limited consensus in multilaboratory testing. Am J Clin Pathol: 2002; 118 4 548 557 (Pubitemid 44698512)
23. Favaloro EJ, Wong RC, Silvestrini R, McEvoy R, Jovanovich S, Roberts-Thomson P. A multilaboratory peer assessment quality assurance program-based evaluation of anticardiolipin antibody, and beta2-glycoprotein I antibody testing. Semin Thromb Hemost: 2005; 31 1 73 84 (Pubitemid 40262140)
24. Favaloro EJ, Wong RCW, Jovanovich S, Roberts-Thomson P. A Review of beta2 -glycoprotein-l antibody testing results from a peer-driven multilaboratory quality assurance program. Am J Clin Pathol: 2007; 127 3 441 448 (Pubitemid 46806339)
25. Reber G, Schousboe I, Tincani A., et al. Inter-laboratory variability of anti-beta2-glycoprotein I measurement. A collaborative study in the frame of the European Forum on Antiphospholipid Antibodies Standardization Group. Thromb Haemost: 2002; 88 1 66 73 (Pubitemid 34752269)
26. Reber G, Tincani A, Sanmarco M, de Moerloose P, Boffa MC.; European Forum on Antiphospholipid Antibodies Standardization Group Variability of anti-beta2 glycoprotein I antibodies measurement by commercial assays. Thromb Haemost: 2005; 94 3 665 672
27. Tincani A, Allegri F, Sanmarco M., et al. Anticardiolipin antibody assay: a methodological analysis for a better consensus in routine determinationsa cooperative project of the European Antiphospholipid Forum. Thromb Haemost: 2001; 86 2 575 583 (Pubitemid 32743269)
28. Willis RE, Harris N, Pierangeli SS. Current international initiatives in antiphospholipid antibody testing. Semin Thromb Hemost: 2012; 38 4 360 374
29. Galli M. Interpretation and recommended testing for antiphospholipid antibodies. Semin Thromb Hemost: 2012; 38 4 348 352
30. de Groot PG, Urbanus RT. The future of antiphospholipid antibody testing. Semin Thromb Hemost: 2012; 38 4 412 420
31. Reber G, Boehlen F, de Moerloose P. Technical aspects in laboratory testing for antiphospholipid antibodies: is standardization an impossible dream? Semin Thromb Hemost: 2008; 34 4 340 346
32. Favaloro EJ, Plebani M, Lippi G. Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing? Clin Chem Lab Med: 2011; 49 12 1965 1973
33. Favaloro EJ. Regulation of in vitro diagnostics (IVDs) for use in Australian pathology laboratories: a gloomy outlook for future pathology testing in this country? Pathology: 2011; 43 4 397 402
34. Pierangeli SS, Harris EN. A protocol for determination of anticardiolipin antibodies by ELISA. Nat Protoc: 2008; 3 5 840 848 (Pubitemid 351639028)
35. Wong RCW, Favaloro EJ, Pollock W., et al. A multi-centre evaluation of the intra-assay and inter-assay variation of commercial and in-house anti-cardiolipin antibody assays. Pathology: 2004; 36 2 182 192 (Pubitemid 38507881)