Nina van Beek1, Cornelia Dähnrich2, Nora Johannsen2, Susanne Lemcke3, Stephanie Goletz4, Franziska Hübner1, Giovanni Di Zenzo5, Marian Dmochowski6, Kossara Drenovska7, Shamir Geller8, Michael Horn9, Cezary Kowalewski10, Ljiljana Medenica11, Dedee F Murrell12, Aikaterini Patsatsi13, Soner Uzun14, Snejina Vassileva7, Detlef Zillikens15, Wolfgang Schlumberger2, Enno Schmidt16. 1. Department of Dermatology, University of Lübeck, Lübeck, Germany. 2. Institute of Experimental Immunology, Euroimmun, Lübeck, Germany. 3. Department of Dermatology, University of Lübeck, Lübeck, Germany; Lübeck Institute of Experimental Dermatology, University of Lübeck, Lübeck, Germany; Human Immunophenotyping Laboratory, University of Lübeck, Lübeck, Germany. 4. Lübeck Institute of Experimental Dermatology, University of Lübeck, Lübeck, Germany. 5. Molecular and Cell Biology Laboratory, Rome, Italy. 6. Autoimmune Blistering Dermatoses Section, Department of Dermatology, Poznan University of Medical Sciences, Poznan, Poland. 7. Department of Dermatology and Venereology, Medical Faculty of Medicine, Sofia, Bulgaria. 8. Dermatology Department Tel Aviv, Sourasky Medical Center, Tel Aviv, Israel. 9. University Institute of Clinical Chemistry and Center of Laboratory Medicine, Inselspital, Bern, Switzerland. 10. Dermatology and Immunodermatology, Medical University of Warsaw, Warsaw, Poland. 11. Department of Dermatology, University of Belgrade, School of Medicine Pasterova 2, Belgrade, Serbia. 12. Department of Dermatology St George Hospital, University of New South Wales School of Medicine, Sydney, Australia. 13. Second University Dermatology Department, Aristotle University School of Medicine, Papageorgiou General Hospital, Thessaloniki, Greece. 14. Akdeniz University Faculty of Medicine Department of Dermatology, Antalya, Turkey. 15. Department of Dermatology, University of Lübeck, Lübeck, Germany; Human Immunophenotyping Laboratory, University of Lübeck, Lübeck, Germany. 16. Department of Dermatology, University of Lübeck, Lübeck, Germany; Lübeck Institute of Experimental Dermatology, University of Lübeck, Lübeck, Germany. Electronic address: enno.schmidt@uksh.de.
Abstract
BACKGROUND: Serologic diagnosis of autoimmune blistering disease (AIBD) usually follows a sophisticated multistep algorithm. OBJECTIVE: We sought validation of a multivariant enzyme-linked immunosorbent assay (ELISA) in the routine diagnosis of AIBD. METHODS: The multivariant ELISA comprising 6 recombinant immunodominant forms of major AIBD target antigens, ie, desmoglein 1, desmoglein 3, envoplakin, BP180, BP230, and type VII collagen was applied in: (1) a cohort of well-characterized AIBD (n = 173) and control sera (n = 130), (2) a prospective multicenter study with 204 sera from patients with newly diagnosed AIBD with positive direct immunofluorescence microscopy, and (3) a prospective monocenter study with 292 consecutive sera from patients with clinical suspicion of AIBD in comparison with the conventional multistep diagnostic algorithm. RESULTS: Concordant results in the multivariant ELISA compared with direct immunofluorescence microscopy were seen in 94% of patients with pemphigus and 71% of patients with pemphigoid (Cohen κ value, 0.95 and 0.66) and with the conventional multistep diagnostic approach in 91% of patients with pemphigus and 88% of patients with bullous pemphigoid and 93% of autoantibody-negative sera (Cohen κ, 0.95, 0.84, and 0.78). LIMITATIONS: IgA autoantibodies and less common target antigens were not analyzed. CONCLUSIONS: The multivariant ELISA is a practical, highly standardized, and widely available novel diagnostic tool for the routine diagnosis of AIBD.
BACKGROUND: Serologic diagnosis of autoimmune blistering disease (AIBD) usually follows a sophisticated multistep algorithm. OBJECTIVE: We sought validation of a multivariant enzyme-linked immunosorbent assay (ELISA) in the routine diagnosis of AIBD. METHODS: The multivariant ELISA comprising 6 recombinant immunodominant forms of major AIBD target antigens, ie, desmoglein 1, desmoglein 3, envoplakin, BP180, BP230, and type VII collagen was applied in: (1) a cohort of well-characterized AIBD (n = 173) and control sera (n = 130), (2) a prospective multicenter study with 204 sera from patients with newly diagnosed AIBD with positive direct immunofluorescence microscopy, and (3) a prospective monocenter study with 292 consecutive sera from patients with clinical suspicion of AIBD in comparison with the conventional multistep diagnostic algorithm. RESULTS: Concordant results in the multivariant ELISA compared with direct immunofluorescence microscopy were seen in 94% of patients with pemphigus and 71% of patients with pemphigoid (Cohen κ value, 0.95 and 0.66) and with the conventional multistep diagnostic approach in 91% of patients with pemphigus and 88% of patients with bullous pemphigoid and 93% of autoantibody-negative sera (Cohen κ, 0.95, 0.84, and 0.78). LIMITATIONS: IgA autoantibodies and less common target antigens were not analyzed. CONCLUSIONS: The multivariant ELISA is a practical, highly standardized, and widely available novel diagnostic tool for the routine diagnosis of AIBD.
Authors: Leo L Wang; Ata S Moshiri; Roberto Novoa; Cory L Simpson; Junko Takeshita; Aimee S Payne; Emily Y Chu Journal: J Am Acad Dermatol Date: 2020-02-14 Impact factor: 11.527