Screening for IgG antinuclear autoantibodies by HEp-2 indirect fluorescent antibody assays and the need for standardization

American Journal of Clinical Pathology

Volumn 137, Issue 5, 2012, Pages 825-830

  Copple, Susan S ^a,b   Giles, S Rashelle ^a   Jaskowski, Troy D ^a   Gardiner, Anna E ^a   Wilson, Andrew M ^a   Hill, Harry R ^a,b  

^a ARUP INSTITUTE FOR CLINICAL AND EXPERIMENTAL PATHOLOGY   (United States)

^b UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

ANA; Antinuclear antibody; HEp 2; IFA; Indirect fluorescent antibody; Polymyositis; Scleroderma; Sj gren syndrome; SLE; Systemic lupus erythematosus

Indexed keywords

ANTINUCLEAR ANTIBODY; IMMUNOGLOBULIN G;

ADULT; ANTIBODY SCREENING; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; CELL SIZE; CONTROLLED STUDY; FEMALE; FLUORESCENCE; FLUORESCENT ANTIBODY ASSAY; HUMAN; IMMUNOASSAY; MAJOR CLINICAL STUDY; MALE; MITOSIS; POLYMYOSITIS; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SCLERODERMA; SJOEGREN SYNDROME; STANDARDIZATION; SYSTEMIC LUPUS ERYTHEMATOSUS; FLUORESCENT ANTIBODY TECHNIQUE; IMMUNOLOGY; MIDDLE AGED; REPRODUCIBILITY; STANDARD;

ADULT; ANTIBODIES, ANTINUCLEAR; ARTHRITIS, RHEUMATOID; FEMALE; FLUORESCENT ANTIBODY TECHNIQUE, INDIRECT; HUMANS; IMMUNOGLOBULIN G; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; MIDDLE AGED; REPRODUCIBILITY OF RESULTS;

EID: 84862630398     PISSN: 00029173     EISSN: 19437722     Source Type: Journal    
DOI: 10.1309/AJCPICNFG7UCES1S     Document Type: Article

References (22)

1. Egner W. The use of laboratory tests in the diagnosis of SLE. J Clin Pathol. 2000;53:424-432. (Pubitemid 30396463)
2. Sinico RA, Bollini B, Sabadini E, et al. The use of laboratory tests in diagnosis and monitoring of systemic lupus erythematosus. J Nephrol. 2002;15(suppl 6):S20-S27. (Pubitemid 44185608)
3. Costenbader KH, Karlson EW, Mandl LA. Defining lupus cases for clinical studies: the Boston weighted criteria for the classification of systemic lupus erythematosus. J Rheumatol. 2002;29:2545-2550. (Pubitemid 35416959)
4. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus [letter]. Arthritis Rheum. 1997;40:1725.
5. Fenger M, Wiik A, Hoier-Madsen M, et al. Detection of antinuclear antibodies by solid-phase immunoassays and immunofluorescence analysis. Clin Chem. 2004;50:2141-2147. (Pubitemid 39425853)
6. Burlingame R, Peebles C. Detection of antibodies. In: Pollard KM, ed. Autoantibodies and Autoimmunity: Molecular Mechanisms in Health and Disease. Weinheim, Germany: Wiley-VCH; 2006:159-188.
7. Fritzler MJ, Wiik A, Tan EM, et al. A critical evaluation of enzyme immunoassay kits for detection of antinuclear autoantibodies of defined specificities, III: comparative performance characteristics of academic and manufacturers' laboratories. J Rheumatol. 2003;30:2374-2381. (Pubitemid 37413896)
8. Peterson LK, Wells D, Shaw L, et al. Novel method for quantitative ANA measurement using near-infrared imaging. J Immunol Methods. 2009;349:1-2.
9. Sack U, Conrad K, Csernok E, et al. Autoantibody detection by immunofluorescence on HEp-2 cells [in German]. Dtsch Med Wochenschr. 2009;134:1278-1282.
10. Tonuttia E, Bassetti D, Piazza A, et al. Diagnostic accuracy of ELISA methods as an alternative screening test to indirect immunofluorescence for the detection of antinuclear antibodies: evaluation of five commercial kits. Autoimmunity. 2004;37:171-176. (Pubitemid 38594280)
11. Tan EM, Smolen JS, McDougal JS, et al. A critical evaluation of enzyme immunoassays for the detection of antinuclear autoantibodies of defined specificities, I: precision, sensitivity, and specificity. Arthritis Rheum. 1999;42:455-464. (Pubitemid 29136093)
12. American College of Rheumatology. Current Practice Issues: ACR Tracking Concerns About ANA Testing Results. Atlanta, GA: American College of Rheumatology; 2009.
13. Bradwell AR, Hughes RG, Karim AR. Immunofluorescent antinuclear antibody tests. In: Detrick B, Hamilton RG, Fold JD, eds. Manual of Clinical Laboratory Immunology. 7th ed. Washington, DC: ASM Press; 2006:995-1006.
14. Emlen W, O'Neill L. Clinical significance of antinuclear antibodies: comparison of detection with immunofluorescence and enzyme-linked immunosorbent assays. Arthritis Rheum. 1997;40:1612-1618. (Pubitemid 27426154)
15. Swaak AJ. Diagnostic significance of antinuclear antibodies [in Dutch]. Ned Tijdschr Geneeskd. 2000;144:585-589.
16. Qin X, Tao X, Chen ZJ, et al. Comparison of indirect immunofluorescence assay and ELISA for detecting antinuclear antibodies and anti-double-stranded DNA antibodies [in Chinese]. Nan Fang Yi Ke Da Xue Xue Bao. 2009;29:472-475.
17. Department of Health and Human Services. Arthritis Foundation-Centers for Disease Control Reference Serum for Human Antibodies to SS-A/Ro. Catalog No. IS2105; lot No. 83-0026. May 26, 1983 (rev. January 2005).
18. Monce NM Jr, Cappel VL, Saqueton CB. A comparison of two fixatives on IFA HEp-2 slides for the detection of antinuclear antibodies. J Immunoassay. 1994;15:55-68. (Pubitemid 24060768)
19. Hahm D, Anderer U. Establishment of HEp-2 cell preparation for automated analysis of ANA fluorescence pattern. Cytometry A. 2006;69:178-181.
20. Clinical and Laboratory Standards Institute (CLSI). Quality assurance of laboratory tests for autoantibodies to nuclear antigens: (1) Indirect fluorescent assay for microscopy and (2) microtiter enzyme immunoassay methods. Approved guideline; second edition. Wayne, PA: CLSI; 2006. CLSI document I/LA2-A2.
21. Meroni PL, Schur PH. ANA screening: an old test with new recommendations. Ann Rheum Dis. 2010;69:1420-1422.
22. Copple SS, Sawitzke AD, Wilson AD, et al. Enzyme linked immunoassay (ELISA) screening then indirect immunofluorescence (IFA) confirmation of antinuclear antibodies: a statistical analysis. Am J Clin Pathol. 2011;135:678-684.