Longitudinal analysis of ANA in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort.
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AuthorChoi, May Yee
Clarke, Ann Elaine
Wallace, Daniel J
Merrill, Joan T
Fortin, Paul R
Gladman, Dafna D
Bruce, Ian N
Ginzler, Ellen M
Dooley, Mary Anne
Alarcón, Graciela S
van Vollenhoven, Ronald F
Kamen, Diane L
Buyon, Jill P
Costenbader, Karen H
Fritzler, Marvin J
Journal titleAnnals of the rheumatic diseases
Publication Begin page1143
Publication End page1150
MetadataShow full item record
AbstractA 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.
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.
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.
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.
CitationChoi MY, Clarke AE, Urowitz M, Hanly J, St-Pierre Y, Gordon C, Bae SC, Romero-Diaz J, Sanchez-Guerrero J, Bernatsky S, Wallace DJ, Isenberg D, Rahman A, Merrill JT, Fortin PR, Gladman DD, Bruce IN, Petri M, Ginzler EM, Dooley MA, Ramsey-Goldman R, Manzi S, Jönsen A, Alarcón GS, van Vollenhoven RF, Aranow C, Mackay M, Ruiz-Irastorza G, Lim S, Inanc M, Kalunian K, Jacobsen S, Peschken C, Kamen DL, Askanase A, Buyon JP, Costenbader KH, Fritzler MJ. Longitudinal analysis of ANA in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort. Ann Rheum Dis. 2022 Aug;81(8):1143-1150. doi: 10.1136/annrheumdis-2022-222168. Epub 2022 Mar 25. PMID: 35338033.
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Except where otherwise noted, this item's license is described as © Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.
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