Lupus & antiphospholipid syndrome
Longitudinal study of patients with discrepant results in CLIFT and a solid-phase dsDNA antibody assay: does a gold standard dsDNA assay exist?
Authors' conclusion
The study showed that CLIFT could be negative in both treated and newly diagnosed SLE, thus underlining the importance of follow-up of dsDNA-positive results using solid-phase tests.
Study context
- Population
- Patients referred for suspected connective tissue diseases or followed up after diagnosis, ANA-positive by immunofluorescence assay (IFA) on Hep-2 cells and positive for fluorescence enzyme immunoassay (FEIA) dsDNA, 2016–2018, followed up until December 2021417 samples
- Participants
- 257 patients
- Exposure
- FEIA dsDNA vs CLIFT results in ANA-positive, FEIA dsDNA-positive patients
- FEIA+, CLIFT+n = 83
- FEIA+, CLIFT-n = 139
- Outcome
- Test agreement and SLE diagnosis
Methodological detailsobservational, longitudinal, CLIFT testing after FEIA dsDNA results ≥10 UI/ml
- Observational
- Longitudinal
- CLIFT testing after FEIA dsDNA results ≥10 UI/ml
Main finding
As reported in the abstract
Observational data: associations, not effects.
Further findings
- Systemic lupus erythematous (SLE) diagnosis among patients with discrepant results (FEIA+, CLIFT-)
- 41.7% · 58 of 139
Previously diagnosed SLE under treatment, among discrepant results
- Previously diagnosed and under treatment
- 47 (33.8%)
New diagnosis of SLE within 4 years of initial screening, among discrepant results
- New diagnosis of SLE
- 11 (7.9%)
Discrepant results without lupus criteria during follow-up · follow-up period
- Did not meet lupus criteria
- 81 of the 139 patients (57.5%)
Original publication
Longitudinal study of patients with discrepant results in CLIFT and a solid-phase dsDNA antibody assay: does a gold standard dsDNA assay exist? Lupus Sci Med. Published 30 October 2023. doi:10.
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