Mahler, M., Meroni, P. L., Bossuyt, X. & Fritzler, M. J. Current concepts and future directions for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. J. Immunol. Res. 2014, 315179 (2014).
Meroni, P. L. & Schur, P. H. ANA screening: an old test with new recommendations. Ann. Rheum. Dis. 69, 1420–1422 (2010).
CAS PubMed Google Scholar
Aringer, M. et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann. Rheum. Dis. 78, 1151–1159 (2019).
Shiboski, C. H. et al. 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren’s syndrome: a consensus and data-driven methodology involving three international patient cohorts. Ann. Rheum. Dis. 76, 9–16 (2017).
van den Hoogen, F. et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Ann. Rheum. Dis. 72, 1747–1755 (2013).
Alarcon-Segovia, D. & Villareal, M. Classification and diagnostic criteria for mixed connective tissue disease. in Mixed connective tissue diseases and antinuclear antibodies (eds Kasukawa, R. & Sharp, G. C.) 33–40 (Elsevier, 1987).
Lundberg, I. E. et al. 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups. Ann. Rheum. Dis. 76, 1955–1964 (2017).
Damoiseaux, J. et al. Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective. Ann. Rheum. Dis. 78, 879–889 (2019).
Chan, E. K. et al. Report of the First International Consensus on Standardized Nomenclature of Antinuclear Antibody HEp-2 Cell Patterns 2014–2015. Front. Immunol. 6, 412 (2015).
Cavazzana, I. et al. Evaluation of a novel particle-based assay for detection of autoantibodies in idiopathic inflammatory myopathies. J. Immunol. Methods 474, 112661 (2019).
CAS PubMed Google Scholar
Agmon-Levin, N. et al. International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann. Rheum. Dis. 73, 17–23 (2014).
CAS PubMed Google Scholar
Tan, E. M. et al. Range of antinuclear antibodies in “healthy” individuals. Arthritis Rheum. 40, 1601–1611 (1997).
CAS PubMed Google Scholar
Leuchten, N. et al. Detection of antinuclear antibodies for classifying systemic lupus erythematosus: a systematic literature review and meta-regression of diagnostic data. Arthritis Care Res. 70, 428–438 (2018).
CAS Google Scholar
Op De Beeck, K. et al. Detection of antinuclear antibodies by indirect immunofluorescence and by solid phase assay. Autoimmun. Rev. 10, 801–808 (2011).
CAS PubMed Google Scholar
Willems, P. et al. Screening for connective tissue disease-associated antibodies by automated immunoassay. Clin. Chem. Lab. Med. 56, 909–918 (2018).
CAS PubMed Google Scholar
Willems, P. et al. Antinuclear antibody as entry criterion for classification of systemic lupus erythematosus: pitfalls and opportunities. Ann. Rheum. Dis. 78, e76 (2019).
Mariz, H. A. et al. Pattern on the antinuclear antibody-HEp-2 test is a critical parameter for discriminating antinuclear antibody-positive healthy individuals and patients with autoimmune rheumatic diseases. Arthritis Rheum. 63, 191–200 (2011).
CAS PubMed Google Scholar
Vulsteke, J. B. et al. Titre-specific positive predictive value of antinuclear antibody patterns. Ann. Rheum. Dis. pii: annrheumdis-2019–216245 (2019).
Albesa, R. et al. Increased prevalence of anti-DFS70 antibodies in young females: experience from a large international multi-center study on blood donors. Clin. Chem. Lab. Med. 57, 999–1005 (2019).
CAS PubMed Google Scholar
Conrad, K., Röber, N., Andrade, L. E. & Mahler, M. The clinical relevance of anti-DFS70 autoantibodies. Clin. Rev. Allergy Immunol. 52, 202–216 (2017).
CAS PubMed Google Scholar
Mahler, M., Andrade, L. E., Casiano, C. A., Malyavantham, K. & Fritzler, M. J. Anti-DFS70 antibodies: an update on our current understanding and their clinical usefulness. Expert. Rev. Clin. Immunol. 15, 241–250 (2019).
CAS PubMed Google Scholar
Bonroy, C. et al. The importance of detecting anti-DFS70 in routine clinical practice: comparison of different care settings. Clin. Chem. Lab. Med. 56, 1090–1099 (2018).
CAS PubMed Google Scholar
Bossuyt, X. et al. Detection of antinuclear antibodies by automated indirect immunofluorescence analysis. Clin. Chim. Acta 415, 101–106 (2013).
CAS PubMed Google Scholar
Claessens, J. et al. Solid phase assays versus automated indirect immunofluorescence for detection of antinuclear antibodies. Autoimmun. Rev. 17, 533–540 (2018).
CAS PubMed Google Scholar
Van Hoovels, L. et al. Analytical performance of the single well titer function of NOVA View®: good enough to omit ANA IIF titer analysis? Clin. Chem. Lab. Med. 56, 258–261 (2018).
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. 54, e63–e66 (2016).
CAS PubMed Google Scholar
Schouwers, S. et al. Value-added reporting of antinuclear antibody testing by automated indirect immunofluorescence analysis. Clin. Chem. Lab. Med. 52, 547–551 (2014).
CAS PubMed Google Scholar
Bossuyt, X. et al. Harmonization of clinical interpretation of antinuclear antibody test results by solid phase assay and by indirect immunofluorescence through likelihood ratios. Autoimmun. Rev. 11, 102386 (2019).
Bossuyt, X. & Luyckx, A. Antibodies to extractable nuclear antigens in antinuclear antibody-negative samples. Clin. Chem. 51, 2426–2427 (2005).
CAS PubMed Google Scholar
Hoffman, I. E. A., Peene, I., Veys, E. & De Keyser, F. Detection of specific antinuclear reactivities in patients with negative anti-nuclear antibody immunofluorescence screening test. Clin. Chem. 48, 2171–2176 (2002).
CAS PubMed Google Scholar
Mahler, M. et al. International multicenter evaluation of autoantibodies to ribosomal P proteins. Clin. Vaccine Immunol. 13, 77–83 (2006).
Fritzler, M. J., Choi, M. Y. & Mahler, M. The anti-nuclear antibody (ANA) test in the diagnosis of anti-synthetase syndrome and other autoimmune myopathies (AIM). J. Rheumatol. 45, 444–445 (2018).
CAS PubMed Google Scholar
Ceribelli, A. et al. Anti-MJ/NXP-2 autoantibody specificity in a cohort of adult Italian patients with polymyositis/dermatomyositis. Arthritis Res. Ther. 14, R97 (2012).
Stuhlmüller, B., Schneider, U., González-González, J. B. & Feist, E. Disease specific autoantibodies in idiopathic inflammatory myopathies. Front. Neurol. 10, 4382019 (2019).
Pisetsky, D. S., Thompson, D. K., Wajdula, J., Diehl, A. & Sridharan, S. Variability in antinuclear antibody testing to assess patient eligibility for clinical trials of novel treatments for systemic lupus erythematosus. Arthritis Rheumatol. 71, 1534–1538 (2019).
CAS PubMed Google Scholar
Pisetsky, D. S., Spencer, D. M., Lipsky, P. E. & Rovin, B. H. Assay variation in the detection of antinuclear antibodies in the sera of patients with established SLE. Ann. Rheum. Dis. 77, 911–913 (2018).
CAS PubMed Google Scholar
Pregnolato, F., Borghi, M. O., Meroni, P. L. & Forum Interdisciplinare per la Ricerca sulle Malattie Autoimmuni (FIRMA) Study Group. Pitfalls of antinuclear antibody detection in systemic lupus erythematosus: the positive experience of a national multicentre study. Ann. Rheum. Dis. 78, e50 (2019).
Pham, B. N., Albarede, S., Guyard, A., Burg, E. & Maisonneuve, P. Impact of external quality assessment on antinuclear antibody detection performance. Lupus. 14, 113–119 (2005).
CAS PubMed Google Scholar
Van Blerk, M. et al. Current practices in antinuclear antibody testing: results from the Belgian External Quality Assessment Scheme. Clin. Chem. Lab. Med. 47, 102–108 (2009).
Van Hoovels, L., Schouwers, S., Van den Bremt, S. & Bossuyt, X. Variation in antinuclear antibody detection by automated indirect immunofluorescence analysis. Ann Rheum Dis. 78, e48 (2018).
van der Pol, P., Bakker-Jonges, L. E., Kuijpers, J. H. S. A. M. & Schreurs, M. W. J. Analytical and clinical comparison of two fully automated immunoassay systems for the detection of autoantibodies to extractable nuclear antigens. Clin. Chim. Acta. 476, 54–159 (2018).
Jeong, S. et al. Evaluation of an automated screening assay, compared to indirect immunofluorescence, an extractable nuclear antigen assay, and a line immunoassay in a large cohort of Asian patients with antinuclear antibody-associated rheumatoid diseases: a multicenter retrospective study. J. Immunol. Res. 2018, 9094217 (2018).
Robier, C., Amouzadeh-Ghadikolai, O., Stettin, M. & Reicht, G. Comparison of the clinical utility of the Elia CTD Screen to indirect immunofluorescence on HEp-2 cells. Clin. Chem. Lab. Med. 54, 365–370 (2016).
Otten, H. G. et al. Measurement of antinuclear antibodies and their fine specificities: time for a change in strategy? Clin. Exp. Rheumatol. 35, 462–470 (2017).
Bentow, C. et al. Clinical performance evaluation of a novel, automated chemiluminescent immunoassay, QUANTA Flash CTD Screen Plus. Immunol. Res. 61, 110–116 (2015).
CAS PubMed Google Scholar
Bizzaro, N. et al. The association of solid-phase assays to immunofluorescence increases the diagnostic accuracy for ANA screening in patients with autoimmune rheumatic diseases. Autoimmun. Rev. 17, 541–547 (2018).
CAS PubMed Google Scholar
Op De Beéck, K. et al. Antinuclear antibody detection by automated multiplex immunoassay in untreated patients at the time of diagnosis. Autoimmun. Rev. 12, 137–143 (2012).
de Almeida Brito, F. et al. Diagnostic Evaluation of ELISA and chemiluminescent assays as alternative screening tests to indirect immunofluorescence for the detection of antibodies to cellular antigens. Am. J. Clin. Pathol. 145, 323–331 (2016).
Orme, M. E., Andalucia, C., Sjölander, S. & Bossuyt, X. A hierarchical bivariate meta-analysis of diagnostic test accuracy to provide direct comparisons of immunoassays versus indirect immunofluorescence for initial screening of connective tissue diseases. Clin. Chem. Lab. Med. https://doi.org/10.1515/cclm-2020-0094 (2020).
Orme, M. E., Andalucia, C., Sjölander, S. & Bossuyt, X. A comparison of a fluorescence enzyme immunoassay versus indirect immunofluorescence for initial screening for connective tissue diseases: systematic literature review and meta-analysis of diagnostic test accuracy studies. Best. Pract. Res. Clin. Rheumatol. 32, 521–534 (2018).
Bossuyt, X. et al. Antinuclear antibodies by indirect immunofluorescence and solid phase assays. Ann. Rheum. Dis. 79, e65 (2019).
Bossuyt, X. & Fieuws, S. Detection of antinuclear antibodies: added value of solid phase assay? Ann. Rheum. Dis. 73, e10 (2014).
Meroni, P. L. et al. Unending story of the indirect immunofluorescence assay on HEp-2 cells: old problems and new solutions? Ann. Rheum. Dis. 78, e46 (2019).
Pisetsky, D. S., Spencer, D. M., Rovin, B. & Lipsky, P. E. Role of ANA testing in the classification of patients with systemic lupus erythematosus. Ann. Rheum. Dis. https://doi.org/10.1136/annrheumdis-2019-216259 (2019).
Pisetsky, D. S., Spencer, D. M., Lipsky, P. E. & Rovin, B. H. Response to ‘Antinuclear antibodies by indirect immunofluorescence and solid phase assays’ by Bossuyt et al. Ann. Rheum. Dis. 79, e66 (2019).
Bizzaro, N. Can solid-phase assays replace immunofluorescence for ANA screening? Ann. Rheum. Dis. 79, e32 (2018).
Pisetsky, D. S., Bossuyt, X. & Meroni, P. L. ANA as an entry criterion for the classification of SLE. Autoimmun. Rev. 18, 102400 (2019).
CAS PubMed Google Scholar
Damoiseaux, J. et al. Autoantibodies in idiopathic inflammatory myopathies: clinical associations and laboratory evaluation by mono- and multispecific immunoassays. Autoimmun. Rev. 18, 293–305 (2019).
CAS PubMed Google Scholar
Cavazzana, I. et al. Testing for myositis specific autoantibodies: comparison between line blot and immunoprecipitation assays in 57 myositis sera. J. Immunol. Methods 433, 1–5 (2016).
CAS PubMed Google Scholar
Vulsteke, J. B. et al. Detection of myositis-specific antibodies. Ann. Rheum. Dis. 78, e7 (2019).
Platteel, A. C. M. et al. Frequencies and clinical associations of myositis-related antibodies in The Netherlands: a one-year survey of all Dutch patients. J. Transl Autoimmunity 2, 100013 (2019).
Infantino, M. et al. Combining immunofluorescence with immunoblot assay improves the specificity of autoantibody testing for myositis. Rheumatology 58, 1239–1244 (2019).
CAS PubMed Google Scholar
Picard, C. et al. Heterogeneous clinical spectrum of anti-SRP myositis and importance of the methods of detection of anti-SRP autoantibodies: a multicentric study. Immunol. Res. 64, 677–686 (2016).
CAS PubMed Google Scholar
Kaji, K. et al. Autoantibodies to RuvBL1 and RuvBL2: a novel systemic sclerosis-related antibody associated with diffuse cutaneous and skeletal muscle involvement. Arthritis Care Res. 66, 575–584 (2014).
CAS Google Scholar
Hennes, E. M. et al. International Autoimmune Hepatitis Group. Simplified criteria for the diagnosis of autoimmune hepatitis. Hepatology 48, 169–176 (2008).
Alvarez, F. et al. International Autoimmune Hepatitis Group Report: review of criteria for diagnosis of autoimmune hepatitis. J. Hepatol. 31, 929–938 (1999).
CAS PubMed Google Scholar
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J. Hepatol. 67, 145–172 (2017).
Martini, A. et al. Toward new classification criteria for juvenile idiopathic arthritis: first steps, Pediatric Rheumatology International Trials Organization International Consensus. J. Rheumatol. 46, 190–197 (2019).
Fierz, W. & Bossuyt, X. Likelihood ratios as value proposition for diagnostic laboratory tests. J. Appl. Lab. Med. 5, 1061–1069 (2020).
Choi, B. C. Slopes of a receiver operating characteristic curve and likelihood ratios for a diagnostic test. Am. J. Epidemiol. 148, 1127–1132 (1998).
CAS PubMed Google Scholar