dc.creator | Scholz J., Grossmann K., Knütter I., Hiemann R., Sowa M., Röber N., Rödiger S., Schierack P., Reinhold D., Bogdanos D.P., Meroni P.L., Radice A., Conrad K., Roggenbuck D. | en |
dc.date.accessioned | 2023-01-31T09:54:39Z | |
dc.date.available | 2023-01-31T09:54:39Z | |
dc.date.issued | 2015 | |
dc.identifier | 10.1515/cclm-2015-0083 | |
dc.identifier.issn | 14346621 | |
dc.identifier.uri | http://hdl.handle.net/11615/78855 | |
dc.description.abstract | Background: For the serological diagnosis of systemic autoimmune rheumatic diseases, a two-tier approach starting with sensitive antinuclear antibody (ANA) detection by indirect immunofluorescence (IIF) on HEp-2 cells followed by characterization of positive findings with different immunoassays is recommended. To overcome drawbacks of this approach, we developed a novel technique allowing the combination of screening and simultaneous confirmatory testing. For the first time, this creates the basis for second generation ANA testing. Methods: ANA and autoantibodies (autoAbs) to double-stranded DNA (dsDNA), CENP-B, SS-A/Ro52, SS-A/Ro60, SS-B/La, RNP-Sm, Sm, and Scl-70 were determined by IIF and enzyme-linked immunosorbent assay (ELISA), respectively, and compared to simultaneous analysis thereof by second generation ANA analysis in patients with systemic lupus erythematosus (n=174), systemic sclerosis (n=103), Sjögren's syndrome (n=46), rheumatoid arthritis (n=36), mixed and undetermined connective tissue diseases (n=13), myositis (n=21), infectious disease (n=21), autoimmune liver disease (n=93), inflammatory bowel disease (n=78), paraproteinemia (n=11), and blood donors (n=101). Results: There was very good agreement of second generation ANA testing with classical one by IIF and ELISA regarding testing for ANA and autoAbs to dsDNA, CENP-B, SS-B, RNP-Sm, Scl-70, SS-A/Ro52, and SS-A/Ro60 (Cohen's κ>0.8). The agreement for anti-Sm autoAb was good (κ=0.77). The differences of both approaches were not significant for autoAbs to SS-B/La, RNP-Sm, Scl-70, SS-A/Ro60, and SS-A/Ro52 (McNemar's test, p>0.05, respectively). Conclusions: Second generation ANA testing can replace the two-tier analysis by combining IIF screening with multiplex confirmative testing. This addresses shortcomings of classical ANA analysis like false-negative ANA findings and lack of laboratory efficiency and standardization. © 2015, Dirk Roggenbuck et al., published by De Gruyter 2015. | en |
dc.language.iso | en | en |
dc.source | Clinical Chemistry and Laboratory Medicine | en |
dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84946882239&doi=10.1515%2fcclm-2015-0083&partnerID=40&md5=865f2bccefaeb09f50888b1f6386e431 | |
dc.subject | antinuclear antibody | en |
dc.subject | centromere protein B | en |
dc.subject | double stranded DNA antibody | en |
dc.subject | La antibody | en |
dc.subject | Ro antibody | en |
dc.subject | scl 70 antibody | en |
dc.subject | antinuclear antibody | en |
dc.subject | adult | en |
dc.subject | aged | en |
dc.subject | antibody detection | en |
dc.subject | antibody screening | en |
dc.subject | Article | en |
dc.subject | autoimmune hepatitis | en |
dc.subject | autoimmune liver disease | en |
dc.subject | blood donor | en |
dc.subject | clinical assessment | en |
dc.subject | connective tissue disease | en |
dc.subject | controlled study | en |
dc.subject | Crohn disease | en |
dc.subject | cytomegalovirus infection | en |
dc.subject | enzyme linked immunosorbent assay | en |
dc.subject | Epstein Barr virus infection | en |
dc.subject | female | en |
dc.subject | HEp 2 cell line | en |
dc.subject | human | en |
dc.subject | Human immunodeficiency virus infection | en |
dc.subject | immunoassay | en |
dc.subject | immunofluorescence | en |
dc.subject | infection | en |
dc.subject | major clinical study | en |
dc.subject | male | en |
dc.subject | middle aged | en |
dc.subject | mixed connective tissue disease | en |
dc.subject | myositis | en |
dc.subject | paraproteinemia | en |
dc.subject | primary biliary cirrhosis | en |
dc.subject | primary sclerosing cholangitis | en |
dc.subject | priority journal | en |
dc.subject | rheumatoid arthritis | en |
dc.subject | serology | en |
dc.subject | Sjoegren syndrome | en |
dc.subject | systemic lupus erythematosus | en |
dc.subject | systemic sclerosis | en |
dc.subject | ulcerative colitis | en |
dc.subject | very elderly | en |
dc.subject | Autoimmune Diseases | en |
dc.subject | blood | en |
dc.subject | HepG2 cell line | en |
dc.subject | immunology | en |
dc.subject | indirect fluorescent antibody technique | en |
dc.subject | Rheumatic Diseases | en |
dc.subject | Antibodies, Antinuclear | en |
dc.subject | Autoimmune Diseases | en |
dc.subject | Fluorescent Antibody Technique, Indirect | en |
dc.subject | Hep G2 Cells | en |
dc.subject | Humans | en |
dc.subject | Immunoassay | en |
dc.subject | Rheumatic Diseases | en |
dc.subject | Walter de Gruyter GmbH | en |
dc.title | Second generation analysis of antinuclear antibody (ANA) by combination of screening and confirmatory testing | en |
dc.type | journalArticle | en |