The clinical significance of borderline results of the Elia CTD Screen assay

Clinical Chemistry and Laboratory Medicine : CCLM
Christoph Robier, Omid Amouzadeh-Ghadikolai

Abstract

Background Data on the clinical relevance of borderline results of solid-phase assays in the screening for antinuclear antibodies (ANA) are sparse. This study aimed to determine the clinical significance of borderline results of the Elia CTD Screen (ECS; Phadia/Thermo Fisher Scientific, Freiburg, Germany), a fluoroenzymeimmunoassay incorporating 17 recombinant human nuclear antigens. Methods We retrospectively examined the medical records of 143 subjects with borderline ECS results for ANA-associated autoimmune disorders (AASARD) and the association with the results of indirect immunofluorescence (IIF) and confirmatory assays for ANA. Results AASARD were diagnosed in 10 patients (7%) with systemic lupus erythematosus (n=5; four patients were prediagnosed and in clinical remission), polymyositis overlap syndromes (n=2), scleroderma, Raynaud's syndrome and undetermined connective tissue disease (each n=1). Most frequently, homogeneous and nucleolar IIF patterns were found. Positive ANA subsets were observed in three patients. Furthermore, four patients were diagnosed with autoimmune liver diseases and yielded positive IIF in three and positive confirmatory assays in all cases. Taken together, 129 subjects had no AASARD. Within th...Continue Reading

References

Nov 25, 2005·Clinical Chemistry·Xavier Bossuyt, Ariane Luyckx
Jul 12, 2011·Autoimmunity Reviews·Katrijn Op De BeeckXavier Bossuyt
Nov 22, 2013·Annals of the Rheumatic Diseases·Xavier Bossuyt, Steffen Fieuws
Nov 25, 2017·Clinica Chimica Acta; International Journal of Clinical Chemistry·Pieter van der PolMarco W J Schreurs
Jan 8, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Philippe WillemsXavier Bossuyt

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