{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T22:41:41Z","timestamp":1772750501242,"version":"3.50.1"},"reference-count":21,"publisher":"Walter de Gruyter GmbH","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,2,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_cclm-2020-1408_abs_001_w2aab3b7d121b1b6b1aab1c15b1Aa\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Data on the clinical importance of the detection of anti-dsDNA antibodies in patients with negative indirect immunofluorescence on the HEp-2\u00a0cell (IIF) are sparse and are especially not available for all common commercially available assays. This study aimed to assess the clinical significance of anti-dsDNA antibodies determined by the Elia\u2122 dsDNA assay in patients with negative IIF.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-1408_abs_002_w2aab3b7d121b1b6b1aab1c15b2Aa\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We retrospectively examined the medical records of 234 consecutive subjects with detectable anti-dsDNA antibodies determined by the Elia\u2122 dsDNA assay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-1408_abs_003_w2aab3b7d121b1b6b1aab1c15b3Aa\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 124 subjects with detectable anti-dsDNA autoantibodies were IIF-negative, but yielded positive or borderline results in the Elia\u2122 CTD screen assay for antinuclear antibodies (ANA). Within this group, 6\/49 IIF-negative patients (12%) with ANA-associated systemic autoimmune rheumatic disorders (AASARD) and 118\/185 subjects (64%) with various other diseases (Non-AASARD) were identified. There was no statistically significant difference with regard to the concentrations of anti-dsDNA antibodies (p=0.53) between the AASARD and the Non-AASARD group. Within the AASARD group, four patients diagnosed with systemic lupus erythematosus (SLE, treated), discoid lupus erythematosus (untreated), indetermined connective tissue disease (untreated) and polymyositis (treated) had positive anti-dsDNA autoantibodies, whereas two patients with treated SLE, thereby one in remission, had borderline concentrations of anti-dsDNA antibodies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_cclm-2020-1408_abs_004_w2aab3b7d121b1b6b1aab1c15b4Aa\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our findings suggest that the detection of anti-dsDNA antibodies in IIF-negative patients can be of clinical relevance in some cases. Our results further support the combined use of IIF and solid-phase assays in screening algorithms for ANA, in order to avoid overlooking potentially important autoantibody entities.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/cclm-2020-1408","type":"journal-article","created":{"date-parts":[[2020,10,24]],"date-time":"2020-10-24T05:29:07Z","timestamp":1603517347000},"page":"541-546","source":"Crossref","is-referenced-by-count":2,"title":["The clinical relevance of anti-dsDNA antibodies determined by the Elia\u2122 dsDNA assay in patients with negative indirect immunofluorescence on the HEp-2\u00a0cell"],"prefix":"10.1515","volume":"59","author":[{"given":"Christoph","family":"Robier","sequence":"first","affiliation":[{"name":"Institute of Laboratory Diagnostics , Hospital of the Brothers of St. John of God , Graz , Austria"},{"name":"Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University Graz , Graz , Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maximiliane","family":"Haas","sequence":"additional","affiliation":[{"name":"Institute of Laboratory Diagnostics , Hospital of the Brothers of St. John of God , Graz , Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franz","family":"Quehenberger","sequence":"additional","affiliation":[{"name":"Institute of Medical Informatics, Statistics and Documentation, Medical University Graz , Graz , Austria"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2020,10,16]]},"reference":[{"key":"2023033111415847483_j_cclm-2020-1408_ref_001_w2aab3b7d121b1b6b1ab2b1b1Aa","doi-asserted-by":"crossref","unstructured":"Agmon-Levin, N, Damoiseaux, J, Kallenberg, C, Sack, U, Witte, T, Herold, M, et al. International recommendationds for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis 2014;73:17\u201323. https:\/\/doi.org\/10.1136\/annrheumdis-2013-203863.","DOI":"10.1136\/annrheumdis-2013-203863"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_002_w2aab3b7d121b1b6b1ab2b1b2Aa","doi-asserted-by":"crossref","unstructured":"De Leeuw, K, Bungener, L, Roozendaal, C, Bootsma, H, Stegeman, CA. Auto-antibodies to double-stranded DNA as biomarker in systemic lupus erythematosus: comparison of different assays during quiescent and active disease. Rheumatology 2017;56:698\u2013703. https:\/\/doi.org\/10.1093\/rheumatology\/kex314.","DOI":"10.1093\/rheumatology\/kew462"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_003_w2aab3b7d121b1b6b1ab2b1b3Aa","doi-asserted-by":"crossref","unstructured":"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. https:\/\/doi.org\/10.1155\/2014\/315179.","DOI":"10.1155\/2014\/315179"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_004_w2aab3b7d121b1b6b1ab2b1b4Aa","doi-asserted-by":"crossref","unstructured":"Mummert, E, Fritzler, MJ, Sj\u00f6wall, C, Bentow, C, Mahler, M. The clinical utility of anti-double-stranded DNA antibodies and the challenges of their determination. J Immunol Methods 2018;459:11\u20139. https:\/\/doi.org\/10.1016\/j.jim.2018.05.014.","DOI":"10.1016\/j.jim.2018.05.014"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_005_w2aab3b7d121b1b6b1ab2b1b5Aa","doi-asserted-by":"crossref","unstructured":"Aringer, M, Costenbader, K, Daikh, D, Brinks, R, Mosca, M, Ramsey-Goldman, R, et al. European league against Rheumatism\/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis 2019;78:1151\u20139. https:\/\/doi.org\/10.1136\/annrheumdis-2018-214819.","DOI":"10.1136\/annrheumdis-2018-214819"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_006_w2aab3b7d121b1b6b1ab2b1b6Aa","doi-asserted-by":"crossref","unstructured":"Pisetsky, DS, Bossuyt, X, Meroni, PL. ANA as an entry criterion for the classification of SLE. ANA as an entry criterion for the classification of SLE. Autoimmun Rev 2019;18:102400. https:\/\/doi.org\/10.1016\/j.autrev.2019.102400.","DOI":"10.1016\/j.autrev.2019.102400"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_007_w2aab3b7d121b1b6b1ab2b1b7Aa","doi-asserted-by":"crossref","unstructured":"Bossuyt, X, Fieuws, S. Detection of antinuclear antibodies: added value of solid phase assay?. Ann Rheum Dis 2014;73:e10. https:\/\/doi.org\/10.1136\/annrheumdis-2013-204793.","DOI":"10.1136\/annrheumdis-2013-204793"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_008_w2aab3b7d121b1b6b1ab2b1b8Aa","doi-asserted-by":"crossref","unstructured":"Orme, ME, Andalucia, C, Sj\u00f6lander, S, Bossuyt, X. A comparison of a fluorescence enzyme immunoassay versus indirect immunofluorescence for initial screening of connective tissue disease: systematic literature review and meta-analysis of diagnostic test accuracy studies. Best Pract Res Clin Rheumatol 2018;32:521\u201334. https:\/\/doi.org\/10.1016\/j.berh.2019.03.005.","DOI":"10.1016\/j.berh.2019.03.005"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_009_w2aab3b7d121b1b6b1ab2b1b9Aa","doi-asserted-by":"crossref","unstructured":"Bizzaro, N. Can solid-phase assays replace immunofluorescence for ANA screening?. Ann Rheum Dis 2020;79:e32. https:\/\/doi.org\/10.1136\/annrheumdis-2018-214805.","DOI":"10.1136\/annrheumdis-2018-214805"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_010_w2aab3b7d121b1b6b1ab2b1c10Aa","doi-asserted-by":"crossref","unstructured":"Bossuyt, X, Claessens, J, De Langhe, E, Belmondo, T, Westhovens, R, Hue, S, et al. Antinuclear antibodies by indirect immunofluorescence and solid phase assay. Ann Rheum Dis 2020;79:e65. https:\/\/doi.org\/10.1136\/annrheumdis-2019-215443.","DOI":"10.1136\/annrheumdis-2019-215443"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_011_w2aab3b7d121b1b6b1ab2b1c11Aa","doi-asserted-by":"crossref","unstructured":"Bizzaro, N, Brusca, I, Previtali, G, Alessio, MG, Daves, M, Platzgummer, S, 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 2018;17:541\u20137. https:\/\/doi.org\/10.1016\/j.autrev.2017.12.007.","DOI":"10.1016\/j.autrev.2017.12.007"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_012_w2aab3b7d121b1b6b1ab2b1c12Aa","doi-asserted-by":"crossref","unstructured":"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\u00a0cells. Clin Chem Lab Med 2016;54:1365\u201370. https:\/\/doi.org\/10.1515\/cclm-2015-1051.","DOI":"10.1515\/cclm-2015-1051"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_013_w2aab3b7d121b1b6b1ab2b1c13Aa","doi-asserted-by":"crossref","unstructured":"Bossuyt, X, Luyckx, A. Antibodies to extractable nuclear antigens in antinuclear antibody-negative samples. Clin Chem 2005;51:2426\u20137. https:\/\/doi.org\/10.1373\/clinchem.2005.058552.","DOI":"10.1373\/clinchem.2005.058552"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_014_w2aab3b7d121b1b6b1ab2b1c14Aa","unstructured":"Otten, HG, Brummelhuis, WJ, Fritsch-Stork, R, Leavis, HL, Wisse, BW, van Laar, JM, et al. Measurement of antinuclear antibodies and their fine specificities: time for a change in strategy?. Clin Exp Rheumatol 2017;35:462\u201370."},{"key":"2023033111415847483_j_cclm-2020-1408_ref_015_w2aab3b7d121b1b6b1ab2b1c15Aa","unstructured":"Gladman, DD, Chalmers, A, Urowitz, MB. Systemic lupus erythematosus with negative LE cells and antinuclear factor. J Rheumatol 1978;5:142\u20137."},{"key":"2023033111415847483_j_cclm-2020-1408_ref_016_w2aab3b7d121b1b6b1ab2b1c16Aa","doi-asserted-by":"crossref","unstructured":"Lindstedt, G, Lundberg, PA, Westberg, G, Kaijser, BSLE. Nephritis with positive tests for antibodies against native DNA but negative tests for antinuclear antibodies. Lancet 1977;2:135. https:\/\/doi.org\/10.1016\/s0140-6736(77)90140-4.","DOI":"10.1016\/S0140-6736(77)90140-4"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_017_w2aab3b7d121b1b6b1ab2b1c17Aa","doi-asserted-by":"crossref","unstructured":"Zhao, M. ANA-negative presentation of SLE in man with severe autoimmune neutropenia. Case Rep Med 2016;2016:6853936. https:\/\/doi.org\/10.1155\/2016\/6853936.","DOI":"10.1155\/2016\/6853936"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_018_w2aab3b7d121b1b6b1ab2b1c18Aa","doi-asserted-by":"crossref","unstructured":"Damoiseaux, J, Andrade, LEC, Carballo, OG, Conrad, K, Francescantonia, PLC, Fritzler, MJ, et al. Clinical relevance of HEp-2 indirect immunofluorescence patterns: the international consensus on ANA patterns (ICAP) perspective. Ann Rheum Dis 2019;78:879\u201389. https:\/\/doi.org\/10.1136\/annrheumdis-2018-214436.","DOI":"10.1136\/annrheumdis-2018-214436"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_019_w2aab3b7d121b1b6b1ab2b1c19Aa","unstructured":"Morris, CN, Calobrisi, SD, Matteson, EL. Antinuclear antibody negative lupus associated with dystrophic calcification. J Rheumatol 1998;25:825\u20136."},{"key":"2023033111415847483_j_cclm-2020-1408_ref_020_w2aab3b7d121b1b6b1ab2b1c20Aa","doi-asserted-by":"crossref","unstructured":"Robier, C, Amouzadeh-Ghadikolai, O. The clinical significance of borderline results of the Elia CTD screen assay. Clin Chem Lab Med 2018;56:2088\u201392. https:\/\/doi.org\/10.1515\/cclm-2018-0576.","DOI":"10.1515\/cclm-2018-0576"},{"key":"2023033111415847483_j_cclm-2020-1408_ref_021_w2aab3b7d121b1b6b1ab2b1c21Aa","doi-asserted-by":"crossref","unstructured":"Takase, K, Horton, SC, Ganesha, A, Das, S, McHugh, A, Emery, P, et al. What is the utility of routine ANA testing in predicting development of biological DMARD-induced lupus and vasculitis in patients with rheumatoid arthritis? Data from a single-centre cohort. Ann Rheum Dis 2014;73:1695\u20139. https:\/\/doi.org\/10.1136\/annrheumdis-2014-205318.","DOI":"10.1136\/annrheumdis-2014-205318"}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyter.com\/view\/journals\/cclm\/ahead-of-print\/article-10.1515-cclm-2020-1408\/article-10.1515-cclm-2020-1408.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-1408\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-1408\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T15:20:32Z","timestamp":1680276032000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2020-1408\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,16]]},"references-count":21,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2020,5,12]]},"published-print":{"date-parts":[[2021,2,23]]}},"alternative-id":["10.1515\/cclm-2020-1408"],"URL":"https:\/\/doi.org\/10.1515\/cclm-2020-1408","relation":{},"ISSN":["1437-4331","1434-6621"],"issn-type":[{"value":"1437-4331","type":"electronic"},{"value":"1434-6621","type":"print"}],"subject":[],"published":{"date-parts":[[2020,10,16]]}}}