A re-appraisal of the normal cut-off assignment for anticardiolipin IgM tests

Journal of Thrombosis and Haemostasis

Volumn 4, Issue 10, 2006, Pages 2210-2214

  Budd, R ^a   Harley, E ^a   Quarshie, A ^b   Henderson, V ^b   Harris, E N ^b   Pierangeli, Silvia S ^b,c  

^a Binding Site Group Ltd   (United Kingdom)

^b MOREHOUSE SCHOOL OF MEDICINE   (United States)

^c University of Texas Medical Branch School of Medicine   (United States)

Author keywords

Anticardiolipin antibodies; Antiphospholipid syndrome ELISA; Cut off points; Normal population

Indexed keywords

CARDIOLIPIN ANTIBODY; IMMUNOGLOBULIN M;

ADULT; AGED; ANTIBODY DETECTION; ANTIBODY TITER; ANTIPHOSPHOLIPID SYNDROME; ARTICLE; BLOOD DONOR; CALCULATION; CONTROLLED STUDY; DATA ANALYSIS SOFTWARE; DIAGNOSTIC KIT; ENZYME IMMUNOASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; GROUPS BY AGE; HUMAN; INTERMETHOD COMPARISON; NORMAL HUMAN; PRIORITY JOURNAL; REFERENCE VALUE; SAMPLE SIZE; SEROPREVALENCE; STATISTICAL SIGNIFICANCE;

ADOLESCENT; ADULT; AGED; ANTIBODIES, ANTICARDIOLIPIN; ANTIPHOSPHOLIPID SYNDROME; AUTOANTIBODIES; BLOOD COAGULATION TESTS; CHEMISTRY, CLINICAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOGLOBULIN M; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; PREVALENCE; REPRODUCIBILITY OF RESULTS;

EID: 33748744379     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2006.02134.x     Document Type: Article

References (44)

1. Harris EN. Syndrome of the Black Swan. Br J Rheumatol 1987; 26: 324-7.
2. Wilson WA, Gharavi AE, Koike T, Lockshin MD, Branch DW, Piette JC, Brey R, Derksen R, Harris EN, Hughes GR, Triplett DA, Khamashta MA. International consensus statement on preliminary classification for definite antiphospholipid syndrome. Arthritis Rheum 1999; 42: 1309-11.
3. 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.
4. Harris EN, Gharavi AE, Boey ML, Patel BM, Macworth-Young CG, Loizou S, Hughes GRV. Anti-cardiolipin antibodies: Detection by radioimmunoassay and association with thrombosis in systemic lupus erythematosus. Lancet 1983: Ii: 1211-4.
5. Harris EN, Gharavi AE, Patel SP, Hughes GRV. Evaluation of the anti-cardiolipin antibody test: Report of an international workshop held 4 April 1986. Clin Exp Immunol 1987; 68: 215-22.
6. Harris EN. The second international anticardiolipin standardization workshop/the Kingston Antiphospholipid Antibody study (KAPS) group. Am J Clin Pathol 1990; 94: 476-84.
7. Harris EN, Pierangeli S, Birch D. Anticardiolipin wet workshop report: Vth international symposium on antiphospholipid antibodies. Am J Clin Pathol 1994; 101: 616-24.
8. Pierangeli SS, Stewart M, Silva LK, Harris EN. Report of an anticardiolipin wet workshop during the VIIth international symposium on antiphospholipid antibodies. J Rheumatol 1998; 25: 156-60.
9. De Moerloose P, Reber G, Vogel J-J. Anticardiolipin antibody determination: Comparison of three ELISA assays. Clin Exp Rheumatol 1990: 8: 575-7.
10. Reber G, Arvieux J, Comby E, Degenne D, de Moerloose P, Sanmarco M. Multicenter evaluation of nine commercial kits for the quantitation of anticardiolipin antibodies. Thromb Haemost 1995; 73: 444-52.
11. Tincani A, Allegri F, Sanmarco M, Cinquini N, Taglietti M, Balestrieri B, Koike T, Ichikawa K, Meroni P, Boffa MC. Anticardiolipin antibody assay: A methodological analysis for a better consensus in routine determinations - a cooperative project of the European Antiphospholipid Forum. Thromb Haemost 2001; 86: 575-83.
12. Harris EN, Pierangeli SS. Revisiting the anticardiolipin test and its standardization. Lupus 2002; 11: 269-75.
13. Nash MJ, Camilleri RS, Kunka S, Mackie IJ, Machin SJ, Cohen H. The anticardiolipin assay is required for sensitive screening for antiphospholipid antibodies. J Thromb Haemost 2004; 2: 1077-81.
14. 2 glycoprotein I and anti-prothrombin antibodies in chronic hepatitis. Br J Haematol 1998; 101: 468-74.
15. 2 glycoprotein I in HIV-seropositive patients: relationship with endothelial activation and antimalonic dialdehyde antibodies. Eur J Clin Invest 1998; 28: 115-22.
16. 2 glycoprotein I: analysis of anticardiolipin antibodies in leprosy. Lupus 1994; 3: 515-21.
17. Loizou S, Cazabon JK, Walport MJ, Tait D, So AK. Similarities of specificity and cofactor dependence in serum antiphospholipid antibodies from patients with human parvovirus B19 infection and from those with systemic lupus erythematosus. Arthritis Rheum 1997; 40: 103-8.
18. Wilson WA, Morgan Ost C, Barton EN, Smikle M, Hanchard B, Blattner WA, Doggett S, Gharavi AE. IgA antiphospholipid antibodies in HTLV-1 associated tropical spastic paraparesis. Lupus 1995; 4: 138-41.
19. Santiago MB, Cossemelli W, Tuma MF, Oliviera RM. Anticardiolipin antibodies in infectious diseases. Clin Rheumatol 1989; 8: 23-8.
20. 2 glycoprotein I-dependent anticardiolipin antibodies as a risk factor for reactions in borderline leprosy patients. Int J Lepr Other Mycobact Dis 1998; 66: 387-8.
21. Durupt S, Rosselli S, Manchon J, Lopez M. Presence of antiphospholipid antibodies in 'Legionnaires disease'. Presse Med 1996; 25: 1649.
22. Galvez J, Martin I, Medino D, Pujol E. Thrombophlebitis in a patient with acute Q fever and anticardiolipin antibodies. Med Clin (Barc) 1997; 108: 396-7.
23. 2 glycoprotein I antibodies and lupus anticoagulant in a prospective longitudinal study of children with juvenile idiopathic arthritis. Clin Exp Rheumatol 2002; 20: 101-8.
24. Pierangeli SS, Gharavi AE, Harris EN. Testing for antiphospholipid antibodies: Problems and solutions. Clin Obstet Gynecol 2001; 44: 48-57.
25. Peaceman AH, Silver RK, MacGregor SN, Scool ML. Interlaboratory variation in antiphospholipid antibody testing. Am J Obstet Gynecol 1992; 144: 1780-4.
26. Pierangeli SS, Harris EN. Clinical laboratory testing for the antiphospholipid syndrome. Clin Chim Acta 2005; 357: 17-33.
27. Harris EN, Pierangeli SS. 'Equivocal' antiphospholipid syndrome. J Autoimmun 2000; 15: 81-5.
28. Harris EN, Chan JK, Asherson RA, Aber VR, Gharavi AE, Hughes GR. Thrombosis, recurrent fetal loss and thrombocytopenia. Predictive value of the anti-cardiolipin test. Arch Intern Med 1986; 146: 2153-6.
29. Ginsburg KS, Liang MH, Newcomer L, Goldhaber SZ, Schur PH, Hennekens CH, Stampfer MJ. Anticardiolipin antibodies and the risk for ischemic stroke and venous thrombosis. Ann Intern Med 1992; 117: 997-1002.
30. Levine SR, Salowich-Palm L, Sawaya KL, Perry M, Spencer HJ, Winkler HJ, Alam Z, Carey JL. IgG anticardiolipin titer > 40 GPL and the risk of subsequent thrombo-occlusive events and death. Stroke 1997; 28: 1660-5.
31. Escalante A, Brey RL, Mitchell BD, Dreiner U. Accuracy of anticardiolipin antibodies in identifying a history of thrombosis among patients with systemic lupus erythematosus. Am J Med 1995; 98: 559-67.
32. Long AA, Ginsberg JS, Brill-Edwards P, Johnson M, Turner C, Denburg JA, Bensen WG, Cividino A, Andrew M, Hirsch J. The relationship of antiphospholipid antibodies to thromboembolic disease in systemic lupus erythematosus: A cross sectional study. Thromb Haemost 1991; 66: 520-4.
33. Vila P, Hernandez MC, Lopez-Fernandez MF, Battle J. Prevalence, follow-up and clinical significance of the anticardiolipin antibodies in normal subjects. Thromb Haemost 1994; 72: 209-13.
34. Harris EN, Spinatto JA. Should anticardiolipin tests be performed in otherwise 'normal' pregnant women? Am J Obstet Gynecol 1991; 165: 1272-7.
35. Kalunian KC, Petra JB, Middlekauff HR, Sayre J, Ando DG, Mangotich M, Hahn BH. Clinical significant of a single test for anti-cardiolipin antibodies in patients with systemic lupus erythematosus. Am J Med 1988; 85: 602-8.
36. 2 glycoprotein I antibodies in sera of 61 apparently healthy children at regular preventive visits. Paed Rheumatol 2001; 40: 565-73.
37. Shi W, Krilis SA, Chong BH, Gordon S, Chesterman CN. Prevalence of lupus anticoagulant and anticardiolipin antibodies in a healthy population. Aust N Z J Med 1990; 20: 231-6.
38. Silver RM, Porter TF, van Leeuween I, Jeng G, Scott JR, Branch DW. Anticardiolipin antibodies: Clinical consequences of 'low titers'. Obstet Gynecol 1996; 87: 494-500.
39. Rix P, Stentoft J, Ausnsholt NA, Dueholm M, Tilma KA, Hoier-Madsen M. Lupus anticoagulant and anticardiolipin antibodies in an obstetric population. Acta Obstet Gynecol Scand 1992; 71: 605-9.
40. Fields RA, Toubbeh H, Searles RP, Bankhurst AD. The prevalence of anticardiolipin antibodies in a healthy elderly population and its association with antinuclear antibodies. J Rheumatol 1989; 16: 623-5.
41. Harris EN, Pierangeli SS. A more specific ELISA assay for the detection of antiphospholipid. Clin Immunol Newsletter 1995; 15: 26-8.
42. Merkel PA, Chang Y, Pierangeli SS, Harris EN, Polisson RP. Comparison between the standard anticardiolipin antibody test and a new phospholipid test in patients with a variety of connective tissue diseases. J Rheumatol 1999; 26: 591-6.
43. Harris EN. Annotation: Antiphospholipid antibodies. Br J Haematol 1990; 74: 1-8.
44. Branch DW, Silver R, Pierangeli S, van Leeuwen I, Harris EN. Antiphospholipid antibodies other than lupus anticoagulant and anticardiolipin antibodies in women with recurrent pregnancy loss, fertile controls, and antiphospholipid syndrome. Obstet Gynecol 1997; 90: 642-4.