Diagnostic profile on the IFA 40: HEp-20-10 - an immunofluorescence test for reliable antinuclear antibody screening.
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.
['Rohwäder|Edda|E|', 'Locke|Michael|M|', 'Fraune|Johanna|J|', 'Fechner|Kai|K|']
D000974:Antibodies, Antinuclear D001327:Autoimmune Diseases D019084:Fluorescent Antibody Technique, Indirect D006801:Humans D011933:Reagent Kits, Diagnostic D015203:Reproducibility of Results D012680:Sensitivity and Specificity
HEp-20-10 antinuclear antibodies human epithelial cell line (HEp-2) indirect immunofluorescence assay (IIFA) systemic rheumatic diseases