title: Diagnostic profile on the IFA 40: HEp-20-10 - an immunofluorescence test for reliable antinuclear antibody screening.
abstract: Indirect immunofluorescence assay is the recommended gold standard to test for antinuclear antibodies (ANA), which are important biomarkers for systemic rheumatic autoimmune diseases. It is internationally accepted that indirect immunofluorescence assay ANA screening is most sensitive on human epithelial (HEp-2) cells. The cells present a multitude of antigens that display distinguishable localization patterns in interphase and mitotic cells in indirect immunofluorescence analysis. Here, we present the IFA 40: HEp-20-10 test kit (Euroimmun AG, Lübeck, Germany), which is cleared for sale on the US market by the FDA. The test has been designed for qualitative and semiquantitative screening of ANA in human sera. It uses the commonly applied 1:40 cutoff dilution and the enhanced HEp-20-10 cell line for more efficient pattern recognition and has been validated in various studies and by method comparison. The IFA 40: HEp-20-10 test fulfills the essential criteria for reliable application in autoimmune diagnostics.
authors.affiliation: Institute of Experimental Immunology, Euroimmun AG, Seekamp 31, 23560 Lübeck, Germany.
authors.forename: Edda
authors.initials: E
authors.lastname: Rohwäder
authors.forename: Michael
authors.initials: M
authors.lastname: Locke
authors.forename: Johanna
authors.initials: J
authors.lastname: Fraune
authors.forename: Kai
authors.initials: K
authors.lastname: Fechner
mesh_terms: D000974:Antibodies, Antinuclear / Q000097:blood / Q000276:immunology*; D001327:Autoimmune Diseases / Q000097:blood / Q000175:diagnosis; D019084:Fluorescent Antibody Technique, Indirect / Q000379:methods* / Q000592:standards; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000974:Antibodies, Antinuclear; D011933:Reagent Kits, Diagnostic
keywords: HEp-20-10; antinuclear antibodies; human epithelial cell line (HEp-2); indirect immunofluorescence assay (IIFA); systemic rheumatic diseases