Solomon DH, Kavanaugh AJ, Schur PH, American College of Rheumatology Ad Hoc Committee on Immunologic Testing. Evidence-based guidelines for the use of immunologic tests: antinuclear antibody testing. Arthritis Rheum. 2002;47:434–44.
Bizzaro N, Wiik A. Appropriateness in anti-nuclear antibody testing: from clinical request to strategic laboratory practice. Clin Exp Rheumatol. 2004;22:349–55.
Kavanaugh A, Tomar R, Reveille J, Solomon DH, Homburger HA. Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. American College of Pathologists. Arch Pathol Lab Med. 2000;124:71–81.
Article CAS PubMed Google Scholar
Bizzaro N. Autoantibodies as predictors of disease: the clinical and experimental evidence. Autoimmun Rev. 2007;6:325–33.
Article CAS PubMed Google Scholar
Damoiseaux J, Andrade LE, Fritzler MJ, Shoenfeld Y. Autoantibodies 2015: from diagnostic biomarkers toward prediction, prognosis and prevention. Autoimmun Rev. 2015;14:555–63.
Article CAS PubMed Google Scholar
Mahler M, Fritzler MJ. Epitope specificity and significance in systemic autoimmune diseases. Ann N Y Acad Sci. 2010;1183:267–87.
Article CAS PubMed Google Scholar
Carbone T, Pafundi V, Tramontano G, Gilio M, Padula MC, Padula AA, D’Angelo S. Prevalence and serological profile of anti-DFS70 positive subjects from a routine ANA cohort. Sci Rep. 2019;9(1):2177.
Article PubMed PubMed Central Google Scholar
Wiik AS. Anti-nuclear autoantibodies: clinical utility for diagnosis, prognosis, monitoring, and planning of treatment strategy in systemic immunoinflammatory diseases. Scand J Rheumatol. 2005;34:260–8.
Article CAS PubMed Google Scholar
Agmon-Levin N, Damoiseaux J, Kallenberg C, Sack U, Witte T, Herold M, Bossuyt X, Musset L, Cervera R, Plaza-Lopez A, Dias C, Sousa MJ, Radice A, Eriksson C, Hultgren O, Viander M, Khamashta M, Regenass S, Andrade LE, Wiik A, Tincani A, Rönnelid J, Bloch DB, Fritzler MJ, Chan EK, Garcia-De La Torre I, Konstantinov KN, Lahita R, Wilson M, Vainio O, Fabien N, Sinico RA, Meroni P, Shoenfeld Y. International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis. 2014;73(1):17–23.
Meroni PL, Schur PH. ANA screening: an old test with new recommendations. Ann Rheum Dis. 2010;69(8):1420–2.
Article CAS PubMed Google Scholar
Hiemann R, Bu¨ttner T, Krieger T, Roggenbuck D, Sack U, Conrad K. Challenges of 417 automated screening and differentiation of non-organ specific autoantibodies 418 on HEp-2 cells. Autoimmun Rev. 2009;9:17–22.
Article CAS PubMed Google Scholar
Bizzaro N, Tozzoli R, Tonutti E, Piazza A, Manoni F, Ghirardello A, et al. Variability between methods to determine ANA, antidsDNA and anti-ENA autoantibodies: a collaborative study with the biomedical industry. J Immunol Methods. 1998;219:99–107.
Article CAS PubMed Google Scholar
Song L, Hennink EJ, Young IT, Tanke HJ. Photobleaching kinetics of fluorescein in quantitative fluorescence microscopy. Biophys J. 1995;68:2588–600.
Article CAS PubMed PubMed Central Google Scholar
Wiik AS, Bizzaro N. Missing links in high quality diagnostics of inflammatory systemic rheumatic diseases: it is all about the patient! Auto Immun Highlights. 2012;3(2):35–49.
Article CAS PubMed PubMed Central Google Scholar
Fritzler MJ. The antinuclear antibody test: last or lasting gasp? Arthritis Rheum. 2011;63(1):19–22.
Rigon A, Infantino M, Merone M, Iannello G, Tincani A, Cavazzana I, et al. The inter-observer reading variability in anti-nuclear antibodies indirect (ANA) immunofluorescence test: a multicenter evaluation and a review of the literature. Autoimmun Rev. 2017;16:1224–9.
Article CAS PubMed Google Scholar
Copple SS, Giles SR, Jaskowski TD, Gardiner AE, Wilson AM, Hill HR. Screening for IgG antinuclear autoantibodies by HEp-2 indirect fluorescent antibody assays and the need for standardization. Am J Clin Pathol. 2012;137:825–30.
Infantino M, Meacci F, Grossi V, Manfredi M, Benucci M, Merone M, et al. The burden of the variability introduced by the HEp-2 assay kit and the CAD system in ANA indirect immunofluorescence test. Immunol Res. 2017;65:345–54.
Article CAS PubMed Google Scholar
Mahler M, Meroni PL, Bossuyt X, Fritzler MJ. Current concepts and future directions for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. J Immunol Res. 2014;2014:315179.
Article PubMed PubMed Central Google Scholar
Tozzoli R, Antico A, Porcelli B, Bassetti D. Automation in indirect immunofluorescence testing: a new step in the evolution of the autoimmunology laboratory. Auto Immun Highlights. 2012;13(3):59–65.
Bizzaro N, Antico A, Platzgummer S, Tonutti E, Bassetti D, Pesente F, Tozzoli R, Tampoia M, Villalta D, Study Group on Autoimmune Diseases of the Italian Society of Laboratory Medicine, Italy. Automated antinuclear immunofluorescence antibody screening: a comparative study of six computer-aided diagnostic systems. Autoimmun Rev. 2014;13:292–8.
Article CAS PubMed Google Scholar
van Beers JJBC, Hahn M, Fraune J, Mallet K, Krause C, Hormann W, Fechner K, Damoiseaux JGMC. Performance analysis of automated evaluation of antinuclear antibody indirect immunofluorescent tests in a routine setting. Auto Immun Highlights. 2018;9:8.
Article PubMed PubMed Central Google Scholar
Copple SS, Jaskowski TD, Giles R, Hill HR. Interpretation of ANA indirect immunofluorescence test outside the darkroom using NOVA view compared to manual microscopy. J Immunol Res. 2014;2014:149316.
Article PubMed PubMed Central Google Scholar
Krause C, Ens K, Fechner K, Voigt J, Fraune J, Rohwäder E, Hahn M, Danckwardt M, Feirer C, Barth E, Martinetz T, Stöcker W. EUROPattern Suite technology for computer-aided immunofluorescence microscopy in autoantibody diagnostics. Lupus. 2015;24:516–29.
Article CAS PubMed Google Scholar
Van Hoovels L, Schouwers S, Van den Bremt S, Bogaert L, Vandeputte N, Vercammen M, Bossuyt X. Analytical performance of the single well titer function of NOVA View®: good enough to omit ANA IIF titer analysis? Clin Chem Lab Med. 2018;56:258–61.
Meroni PL, Bizzaro N, Cavazzana I, Borghi MO, Tincani A. Automated tests of ANA immunofluorescence as throughput autoantibody detection technology: strengths and limitations. BMC Med. 2014;3(12):38.
Cinquanta L, Bizzaro N, Pesce G. Standardization and quality assessment under the perspective of automated computer-assisted HEp-2 immunofluorescence assay systems. Front Immunol. 2021;25(12):638863.
Van Hoovels L, Bossuyt X, Manfredi M, Grossi V, Benucci M, Van Den Bremt S, De Baere H, Franceschi D, Tosi E, Meoni M, Bizzaro N, Infantino M. Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test. Clin Chem Lab Med. 2021;59:1247–55.
Chan EK, Damoiseaux J, Carballo OG, Conrad K, de Melo Cruvinel W, Francescantonio PL, Fritzler MJ, Garcia-De La Torre I, Herold M, Mimori T, Satoh M, von Mühlen CA, Andrade LE. Report of the first international consensus on standardized nomenclature of antinuclear antibody HEp-2 cell patterns 2014–2015. Front Immunol. 2015;6:412.
Chan EK, Damoiseaux J, de Melo Cruvinel W, Carballo OG, Conrad K, Francescantonio PL, Fritzler MJ, Garcia-De La Torre I, Herold M, Mimori T, Satoh M, Mühlen CA von, Andrade LE. Report on the second international consensus on ANA pattern (ICAP) workshop in Dresden 2015. Lupus. 2016;25:797–804.
Andrade LEC, Klotz W, Herold M, Conrad K, Rönnelid J, Fritzler MJ, von Mühlen CA, Satoh M, Damoiseaux J, de MeloCruvinel W, Chan EKL, Executive Committee of ICAP. International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I. Clin Chem Lab Med. 2018;56:1783–8.
Article CAS PubMed Google Scholar
Herold M, Klotz W, Andrade LEC, Conrad K, de Melo CW, Damoiseaux J, Fritzler MJ, von Muhlen CA, Satoh M, Chan EKL. International consensus on antinuclear antibody patterns: defining negative results and reporting unidentified patterns. Clin Chem Lab Med. 2018;56:1799–802.
Article CAS PubMed Google Scholar
Oyaert M, Bossuyt X, Ravelingien I, Van Hoovels L. Added value of indirect immunofluorescence intensity of automated antinuclear antibody testing in a secondary hospital setting. Clin Chem Lab Med. 2016;54:e63–6.
Article CAS PubMed Google Scholar
Vulsteke JB, Van Hoovels L, Willems P, Vander Cruyssen B, Vanderschueren S, Westhovens R, Blockmans D, De Langhe E, Bossuyt X. Titre-specific positive predictive value of antinuclear antibody patterns. Ann Rheum Dis. 2021;80:e128.
Schouwers S, Bonnet M, Verschueren P, Westhovens R, Blockmans D, Mariën G, Bossuyt X. Value-added reporting of antinuclear antibody testing by automated indirect immunofluorescence analysis. Clin Chem Lab Med. 2014;52(4):547–51.
Article CAS PubMed Google Scholar
Fierz W, Bossuyt X. Likelihood ratio approach and clinical interpretation of laboratory tests. Front Immunol. 2021;16(12):655262.
Bizzaro N, Bossuyt X, Haapala AM, Shoenfeld Y, Sack U. Accreditation in autoimmune diagnostic laboratories. A position paper of the European Autoimmunity Standardisation Initiative (EASI). Autoimmun Rev. 2017;16:81–6.
ISO 15189:2012. Medical laboratories — requirements for quality and competence. Geneva: ISO; 2012.
Sack U, Bossuyt X, Andreeva H, Antal-Szalmás P, Bizzaro N, Bogdanos D, European Autoimmunity Standardisation Initiative, et al. Quality and best practice in medical laboratories: specific requests for autoimmunity testing. Auto Immun Highlights. 2020;11:12.
Article PubMed PubMed Central Google Scholar
Bogaert L, Van den Bremt S, Schouwers S, Bossuyt X, Van Hoovels L. Harmonizing by reducing inter-run variability: performance evaluation of a quality assurance program for antinuclear antibody detection by indirect immunofluorescence. Clin Chem Lab Med. 2019;57:990–8.
Comments (0)