title: Automated indirect immunofluorescence evaluation of antinuclear autoantibodies on HEp-2 cells.
abstract: Indirect immunofluorescence (IIF) on human epithelial (HEp-2) cells is considered as the gold standard screening method for the detection of antinuclear autoantibodies (ANA). However, in terms of automation and standardization, it has not been able to keep pace with most other analytical techniques used in diagnostic laboratories. Although there are already some automation solutions for IIF incubation in the market, the automation of result evaluation is still in its infancy. Therefore, the EUROPattern Suite has been developed as a comprehensive automated processing and interpretation system for standardized and efficient ANA detection by HEp-2 cell-based IIF. In this study, the automated pattern recognition was compared to conventional visual interpretation in a total of 351 sera. In the discrimination of positive from negative samples, concordant results between visual and automated evaluation were obtained for 349 sera (99.4%, kappa = 0.984). The system missed out none of the 272 antibody-positive samples and identified 77 out of 79 visually negative samples (analytical sensitivity/specificity: 100%/97.5%). Moreover, 94.0% of all main antibody patterns were recognized correctly by the software. Owing to its performance characteristics, EUROPattern enables fast, objective, and economic IIF ANA analysis and has the potential to reduce intra- and interlaboratory variability.
authors.affiliation: Institute for Experimental Immunology, Euroimmun AG, Seekamp 31, 23560 Lübeck, Germany. j.voigt@euroimmun.de
authors.forename: Jörn
authors.initials: J
authors.lastname: Voigt
authors.forename: Christopher
authors.initials: C
authors.lastname: Krause
authors.forename: Edda
authors.initials: E
authors.lastname: Rohwäder
authors.forename: Sandra
authors.initials: S
authors.lastname: Saschenbrecker
authors.forename: Melanie
authors.initials: M
authors.lastname: Hahn
authors.forename: Maick
authors.initials: M
authors.lastname: Danckwardt
authors.forename: Christian
authors.initials: C
authors.lastname: Feirer
authors.forename: Konstantin
authors.initials: K
authors.lastname: Ens
authors.forename: Kai
authors.initials: K
authors.lastname: Fechner
authors.forename: Erhardt
authors.initials: E
authors.lastname: Barth
authors.forename: Thomas
authors.initials: T
authors.lastname: Martinetz
authors.forename: Winfried
authors.initials: W
authors.lastname: Stöcker
mesh_terms: D000974:Antibodies, Antinuclear / Q000097:blood / Q000737:chemistry* / Q000276:immunology*; D057205:Automation, Laboratory / Q000379:methods / Q000592:standards; D045744:Cell Line, Tumor; D004847:Epithelial Cells / Q000737:chemistry* / Q000276:immunology*; D019084:Fluorescent Antibody Technique, Indirect / Q000379:methods* / Q000592:standards; D006801:Humans; D012015:Reference Standards; D012680:Sensitivity and Specificity
chemical_list: D000974:Antibodies, Antinuclear