{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T09:20:23Z","timestamp":1790760023446,"version":"4.1.0"},"reference-count":19,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T00:00:00Z","timestamp":1759190400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Medipan"}],"content-domain":{"domain":["www.mdpi.com"],"crossmark-restriction":true},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Antinuclear antibodies (ANAs) play a crucial role in diagnosing systemic autoimmune rheumatic diseases, particularly systemic lupus erythematosus. The recommended standard for ANA detection is indirect immunofluorescence testing (IIFT) using human epithelial (HEp-2) cells. Since visual interpretation (VI) of IIFT images is time-consuming and labor-intensive, research is focusing on automated interpretation systems that use artificial intelligence (AI). Methods: Consecutive serum samples (number of sera = 143) from routine clinical care were collected from patients visiting our tertiary rheumatology center. ANA were detected by IIFT with visual interpretation and compared with IIFT using the AI-based interpretation system akiron\u00ae NEO (Medipan, 15827 Blankenfelde-Mahlow, Germany). ANA titer levels and patterns were analyzed according to the Competent Level of the International Consensus on ANA Pattern classification. Results: Agreement of positive\/negative ANA discrimination between AI-aided and VI-IIFT at the recommended cut-off of 80 was good (Cohen\u2019s kappa [\u03ba] 0.69) but significantly different (McNemar test, p &lt; 0.0001). At a cut-off of \u22651\/80, the agreement was improved (\u03ba 0.76) and the difference between both methods was non-significant (p = 1.0000). The ANA pattern recognition agreement between both approaches was moderate (\u03ba = 0.54). The direct comparison using only the akiron\u00ae NEO HEp-2 cell ANA assay revealed a good agreement (0.67), which improved to very good (\u03ba = 0.80) when differences between ANA patterns anti-cell (AC)4\/5 and AC2 were neglected. Notably, titer levels in the automated evaluations were frequently assessed at higher values than in the gold standard interpretation. Conclusions: Our study demonstrates a good agreement for positive\/negative ANA discrimination. ANA pattern recognition by AI-aided interpretation showed moderate to very good agreement with VI. Further research and algorithm refinement (e.g., improved pattern recognition and titer calibration) are necessary to support its future implementation as a reliable screening method.<\/jats:p>","DOI":"10.3390\/jcm14196924","type":"journal-article","created":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T09:12:23Z","timestamp":1759223543000},"page":"6924","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pilot Study of AI-Assisted ANA Immunofluorescence Reading\u2014Comparison with Classical Visual Interpretation"],"prefix":"10.3390","volume":"14","author":[{"given":"Sarah","family":"Mayr","sequence":"first","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margit","family":"Dollinger","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1561-9239","authenticated-orcid":false,"given":"Boris","family":"Ehrenstein","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florian","family":"G\u00fcnther","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4648-3575","authenticated-orcid":false,"given":"Olga","family":"Krammer","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"Schuster","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"B\u00fcttner","sequence":"additional","affiliation":[{"name":"Medipan GmbH, 15827 Dahlewitz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rico","family":"Hiemann","sequence":"additional","affiliation":[{"name":"Institute of Biotechnology, Faculty Environment and Natural Sciences, Brandenburg University of Technology Cottbus-Senftenberg, 03046 Cottbus, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Schierack","sequence":"additional","affiliation":[{"name":"Institute of Biotechnology, Faculty Environment and Natural Sciences, Brandenburg University of Technology Cottbus-Senftenberg, 03046 Cottbus, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6861-6827","authenticated-orcid":false,"given":"Dirk","family":"Roggenbuck","sequence":"additional","affiliation":[{"name":"Medipan GmbH, 15827 Dahlewitz, Germany"},{"name":"Institute of Biotechnology, Faculty Environment and Natural Sciences, Brandenburg University of Technology Cottbus-Senftenberg, 03046 Cottbus, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Fleck","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Clinical Immunology, Asklepios Medical Center Bad Abbach, 93077 Bad Abbach, Germany"},{"name":"Department of Internal Medicine I, University Medical Center Regensburg, 93042 Regensburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1136\/annrheumdis-2013-203863","article-title":"International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies","volume":"73","author":"Damoiseaux","year":"2014","journal-title":"Ann. 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