期刊
ANNALS OF THE RHEUMATIC DISEASES
卷 81, 期 8, 页码 1143-1150出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/annrheumdis-2022-222168
关键词
Systemic Lupus Erythematosus; Autoantibodies; Autoimmunity
类别
资金
- Lupus Foundation of America
- Lupus Foundation of America Gary S. Gilkeson Career Development Award
- NIH [K24 AR066109, AR043727, AR069572, RR00046, 1U54TR001353, 8UL1TR000150, UL-1RR--025741, K24-AR--02318, P60AR064464, P60-AR--48098]
- Canadian Institutes of Health Research [MOP-88526]
- Lupus UK
- West Birmingham Hospitals NHS Trust
- NIHR / Wellcome Trust Clinical Research Facility in Birmingham
- Korea Healthcare technology R & D project, Ministry for Health and Welfare, Republic of Korea [A120404]
- Singer Family Fund for Lupus Research
- National Institute for Health Research University College London Hospitals Biomedical Research Centre
- National Institute for Health Research Manchester Biomedical Research Centre
- NIHR/Wellcome Trust Manchester Clinical Research Facility
- Department of Education, Universities and Research of the Basque Government [R01 AR046588, K24 AR002213]
- Danish Rheumatism Association [A1028]
- Novo Nordisk Foundation [A05990]
- MitogenDx
In a longitudinal analysis of a large international incident SLE cohort, three ANA assays demonstrated high positivity rates and commutability. However, over a 5-year follow-up, there was a modest variation in ANA assay performance.
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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