Abstract
Antinuclear antibody (ANA) test results frequently affect the course of patients’ evaluations, diagnosis, and treatment, but different laboratory centers may yield conflicting results. This study investigated the degree of agreement between laboratory results in a group of subjects who had ANA testing performed at two commercial laboratories. This was a chart review study, in which all ANA tests ordered by the authors from one commercial laboratory over a 4-year period were queried. Corresponding patient charts were reviewed, and if ANA testing had also been performed at the second commercial laboratory, subjects were entered into the study. The primary measurement was agreement between paired ANA results, and we performed sensitivity analysis using varying criteria defining agreement (criteria A to criteria D [strictest to most lenient definition of agreement]). Other data captured included relevant data obtained through the course of evaluation (e.g., presenting complaints, exam findings, other laboratory data) and final diagnoses. Of 101 paired ANA tests, there was 18 % agreement according to the strictest criteria and 42 % according to the most lenient. Of the seven subjects with ANA-associated rheumatic disease, none of the paired tests were in agreement according to criteria A (two agreed according to criteria D). Our findings demonstrate poor agreement between paired ANA tests performed at two commercial laboratories. The low level of agreement may have far-reaching clinical implications. Specifically, this finding calls into question the reliability of ANA testing as it is currently performed and suggests that results may in part depend upon the laboratory center to which patients are referred.
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References
Abeles AM, Abeles M (2013) The clinical utility of a positive anti-nuclear antibody test. Am J Med 126:342–348
Slater CA, Davis RB, Shmerling RH (1996) Antinuclear antibody testing. A study of clinical utility. Arch Intern Med 156:1421–1425
McGhee JL, Kickingbird LM, Jarvis JN (2004) Clinical utility of antinuclear antibody tests in children. BMC Pediatr 4:13
Malleson PN, Sailer M, Mackinnon MJ (1997) Usefulness of antinuclear antibody testing to screen for rheumatic diseases. Arch Dis Child 77:299–304
American College of Rheumatology Position Statement: Methodology of Testing for Antinuclear Antibodies. (2009). Available at: http://www.rheumatology.org/practice /clinical/position/ana_position_stmt.pdf.
Gniewek RA, Stites DP, McHugh TM, Hilton JF, Nakagawa M (1997) Comparison of antinuclear antibody testing methods: immunofluorescence assay versus enzyme immunoassay. Clin Diagn Lab Immunol 4:185–188
Jaskowski TD, Schroder C, Martins TB, Mouritsen CL, Litwin CM, Hill HR (1996) Screening for anti nuclear antibodies by enzyme immunoassay. Am J Clin Pathol 105:468–473
Fernandez SA, Lobo AZ, Oliveira ZN, Fukumori LM, Prigo AM, Rivitti EA (2003) Prevalence of antinuclear autoantibodies in the serum of normal blood donors. Rev Hosp Clin Fac Med Sao Paulo 58:315–319
Verstegen G, Duyck MC, Meeus P, Ravelingien I, De Vlam K (2009) Detection and identification of antinuclear antibodies (ANA) in a large community hospital. Acta Clin Belg 64:317–323
Maguire GA, Ginawi A, Lee J, Lim AY, Wood G, Houghton S et al (2009) Clinical utility of ANA measured by ELISA compared with ANA measured by immunofluorescence. Rheumatology (Oxford) 48:1013–1014
Russell AS, Johnston T (2003) Relative value of commercial kits for ANA testing. Clin Exp Rheumatol 21:477–480
Emlen W, O’Neill L (1997) Clinical significance of antinuclear antibodies. Arthritis Rheum 40:1612–1618
Narain S, Richards HB, Satoh M, Sarmiento M et al (2004) Diagnostic accuracy for lupus and other systemic autoimmune diseases in the community setting. Arch Intern Med 164:2435–2441
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Abeles, A.M., Gomez-Ramirez, M., Abeles, M. et al. Antinuclear antibody testing: discordance between commercial laboratories. Clin Rheumatol 35, 1713–1718 (2016). https://doi.org/10.1007/s10067-016-3241-x
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DOI: https://doi.org/10.1007/s10067-016-3241-x