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Longitudinal analysis of ANA in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort

Choi, May Yee ; Clarke, Ann Elaine ; Urowitz, Murray ; Hanly, John ; St-Pierre, Yvan ; Gordon, Caroline ; Bae, Sang Cheol ; Romero-Diaz, Juanita ; Sanchez-Guerrero, Jorge and Bernatsky, Sasha , et al. (2022) In Annals of the Rheumatic Diseases 81(8). p.1143-1150
Abstract

Objectives A perception derived from cross-sectional studies of small systemic lupus erythematosus (SLE) cohorts is that there is a marked discrepancy between antinuclear antibody (ANA) assays, which impacts on clinicians' approach to diagnosis and follow-up. We compared three ANA assays in a longitudinal analysis of a large international incident SLE cohort retested regularly and followed for 5 years. Methods Demographic, clinical and serological data was from 805 SLE patients at enrolment, year 3 and 5. Two HEp-2 indirect immunofluorescence assays (IFA1, IFA2), an ANA ELISA, and SLE-related autoantibodies were performed in one laboratory. Frequencies of positivity, titres or absorbance units (AU), and IFA patterns were compared using... (More)

Objectives A perception derived from cross-sectional studies of small systemic lupus erythematosus (SLE) cohorts is that there is a marked discrepancy between antinuclear antibody (ANA) assays, which impacts on clinicians' approach to diagnosis and follow-up. We compared three ANA assays in a longitudinal analysis of a large international incident SLE cohort retested regularly and followed for 5 years. Methods Demographic, clinical and serological data was from 805 SLE patients at enrolment, year 3 and 5. Two HEp-2 indirect immunofluorescence assays (IFA1, IFA2), an ANA ELISA, and SLE-related autoantibodies were performed in one laboratory. Frequencies of positivity, titres or absorbance units (AU), and IFA patterns were compared using McNemar, Wilcoxon and kappa statistics, respectively. Results At enrolment, ANA positivity (≥1:80) was 96.1% by IFA1 (median titre 1:1280 (IQR 1:640-1:5120)), 98.3% by IFA2 (1:2560 (IQR 1:640-1:5120)) and 96.6% by ELISA (176.3 AU (IQR 106.4 AU-203.5 AU)). At least one ANA assay was positive for 99.6% of patients at enrolment. At year 5, ANA positivity by IFAs (IFA1 95.2%; IFA2 98.9%) remained high, while there was a decrease in ELISA positivity (91.3%, p<0.001). Overall, there was >91% agreement in ANA positivity at all time points and ≥71% agreement in IFA patterns between IFA1 and IFA2. Conclusion In recent-onset SLE, three ANA assays demonstrated commutability with a high proportion of positivity and titres or AU. However, over 5 years follow-up, there was modest variation in ANA assay performance. In clinical situations where the SLE diagnosis is being considered, a negative test by either the ELISA or HEp-2 IFA may require reflex testing.

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type
Contribution to journal
publication status
published
subject
keywords
Autoantibodies, Autoimmunity, Systemic Lupus Erythematosus
in
Annals of the Rheumatic Diseases
volume
81
issue
8
pages
8 pages
publisher
BMJ Publishing Group
external identifiers
  • pmid:35338033
  • scopus:85134226098
ISSN
0003-4967
DOI
10.1136/annrheumdis-2022-222168
language
English
LU publication?
yes
id
e3711108-df40-427a-8236-71635904ecda
date added to LUP
2022-10-10 15:37:14
date last changed
2024-11-01 03:18:59
@article{e3711108-df40-427a-8236-71635904ecda,
  abstract     = {{<p>Objectives A perception derived from cross-sectional studies of small systemic lupus erythematosus (SLE) cohorts is that there is a marked discrepancy between antinuclear antibody (ANA) assays, which impacts on clinicians' approach to diagnosis and follow-up. We compared three ANA assays in a longitudinal analysis of a large international incident SLE cohort retested regularly and followed for 5 years. Methods Demographic, clinical and serological data was from 805 SLE patients at enrolment, year 3 and 5. Two HEp-2 indirect immunofluorescence assays (IFA1, IFA2), an ANA ELISA, and SLE-related autoantibodies were performed in one laboratory. Frequencies of positivity, titres or absorbance units (AU), and IFA patterns were compared using McNemar, Wilcoxon and kappa statistics, respectively. Results At enrolment, ANA positivity (≥1:80) was 96.1% by IFA1 (median titre 1:1280 (IQR 1:640-1:5120)), 98.3% by IFA2 (1:2560 (IQR 1:640-1:5120)) and 96.6% by ELISA (176.3 AU (IQR 106.4 AU-203.5 AU)). At least one ANA assay was positive for 99.6% of patients at enrolment. At year 5, ANA positivity by IFAs (IFA1 95.2%; IFA2 98.9%) remained high, while there was a decrease in ELISA positivity (91.3%, p&lt;0.001). Overall, there was &gt;91% agreement in ANA positivity at all time points and ≥71% agreement in IFA patterns between IFA1 and IFA2. Conclusion In recent-onset SLE, three ANA assays demonstrated commutability with a high proportion of positivity and titres or AU. However, over 5 years follow-up, there was modest variation in ANA assay performance. In clinical situations where the SLE diagnosis is being considered, a negative test by either the ELISA or HEp-2 IFA may require reflex testing. </p>}},
  author       = {{Choi, May Yee and Clarke, Ann Elaine and Urowitz, Murray and Hanly, John and St-Pierre, Yvan and Gordon, Caroline and Bae, Sang Cheol and Romero-Diaz, Juanita and Sanchez-Guerrero, Jorge and Bernatsky, Sasha and Wallace, Daniel J. and Isenberg, David and Rahman, Anisur and Merrill, Joan T. and Fortin, Paul R. and Gladman, Dafna D. and Bruce, Ian N. and Petri, Michelle and Ginzler, Ellen M. and Dooley, Mary Anne and Ramsey-Goldman, Rosalind and Manzi, Susan and Jönsen, Andreas and Alarcón, Graciela S. and Van Vollenhoven, Ronald F. and Aranow, Cynthia and Mackay, Meggan and Ruiz-Irastorza, Guillermo and Lim, Sam and Inanc, Murat and Kalunian, Ken and Jacobsen, Søren and Peschken, Christine and Kamen, Diane L. and Askanase, Anca and Buyon, Jill P. and Costenbader, Karen H. and Fritzler, Marvin J.}},
  issn         = {{0003-4967}},
  keywords     = {{Autoantibodies; Autoimmunity; Systemic Lupus Erythematosus}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{8}},
  pages        = {{1143--1150}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{Annals of the Rheumatic Diseases}},
  title        = {{Longitudinal analysis of ANA in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort}},
  url          = {{http://dx.doi.org/10.1136/annrheumdis-2022-222168}},
  doi          = {{10.1136/annrheumdis-2022-222168}},
  volume       = {{81}},
  year         = {{2022}},
}