Second generation analysis of antinuclear antibody (ANA) by combination of screening and confirmatory testing

被引:27
作者
Scholz, Juliane [2 ]
Grossmann, Kai [2 ]
Knuetter, Ilka [2 ]
Hiemann, Rico [1 ]
Sowa, Mandy [2 ]
Roeber, Nadja [3 ]
Roediger, Stefan [1 ]
Schierack, Peter [1 ]
Reinhold, Dirk [4 ]
Bogdanos, Dimitrios P. [5 ]
Meroni, Pier Luigi [6 ]
Radice, Antonella [7 ]
Conrad, Karsten [3 ]
Roggenbuck, Dirk [1 ,2 ]
机构
[1] Brandenburg Univ Technol Cottbus Senftenberg, Fac Sci, D-01968 Senftenberg, Germany
[2] GA Gener Assays GmbH, Dept Res & Dev, Dahlewitz Berlin, Germany
[3] Tech Univ Dresden, Inst Immunol, D-01062 Dresden, Germany
[4] Univ Magdeburg, Inst Mol & Clin Immunol, D-39106 Magdeburg, Germany
[5] Univ Thessaly, Sch Hlth Sci, Dept Rheumatol, Larisa, Greece
[6] Univ Milan, Ist Auxol Italiano, Dept Clin Sci & Community Hlth, Milan, Italy
[7] San Carlo Borromeo Hosp, Inst Microbiol, Milan, Italy
关键词
antinuclear antibody; digital fluorescence; second generation ANA testing; standardization; systemic autoimmune rheumatic disease; LUCILIAE IMMUNOFLUORESCENCE TEST; RHEUMATOLOGY/EUROPEAN LEAGUE; AUTOMATED INTERPRETATION; CLASSIFICATION CRITERIA; RHEUMATOID-ARTHRITIS; LUPUS-ERYTHEMATOSUS; AMERICAN-COLLEGE; DNA ANTIBODIES; AUTOANTIBODIES; PATTERNS;
D O I
10.1515/cclm-2015-0083
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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), Sjogren'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 kappa>0.8). The agreement for anti-Sm autoAb was good (kappa=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.
引用
收藏
页码:1991 / 2002
页数:12
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