Lupus & antiphospholipid syndrome

Clinical evaluation of the novel digital liquid chip method for anti-dsDNA detection in SLE

Lupus Sci MedPublished Diagnostic accuracy study

Authors' conclusion

DLCM demonstrated substantial agreement with CLIA and held potential for SLE diagnosis and monitoring.

Study context

Population
Patients with SLE and with other autoimmune diseases, Peking Union Medical College Hospital698 SLE, 651 other
Participants
1,349 patients
Comparison
Digital liquid chip method (DLCM) vs indirect immunofluorescence (IIF) vs chemiluminescent immunoassay (CLIA) for anti-dsDNA detection
Outcome
Sensitivity, specificity and AUC of each method and combination at manufacturer cut-offs
Methodological detailsretrospective, consecutive enrolment, single-centre
  • Retrospective
  • Consecutive enrolment
  • Single-centre

Performance

As reported in the abstract

Diagnostic performance for SLE
Test or modelAUCSensitivitySpecificityAccuracy
IIF— not stated in the abstract36.0%98.5%— not stated in the abstract
CLIA— not stated in the abstract48.1%96.3%— not stated in the abstract
DLCM— not stated in the abstract41.4%96.6%— not stated in the abstract
IIF+CLIA0.7554.0%— not stated in the abstract74.1%

AUC

IIF— not stated in the abstract
CLIA— not stated in the abstract
DLCM— not stated in the abstract
IIF+CLIA0.75

Sensitivity

IIF36.0%
CLIA48.1%
DLCM41.4%
IIF+CLIA54.0%

Specificity

IIF98.5%
CLIA96.3%
DLCM96.6%
IIF+CLIA— not stated in the abstract

Accuracy

IIF— not stated in the abstract
CLIA— not stated in the abstract
DLCM— not stated in the abstract
IIF+CLIA74.1%

— not stated in the abstract

  • IIF vs CLIA and DLCM: P < 0.05 — IIF significantly greater
  • CLIA vs IIF and DLCM: P < 0.001 — CLIA highest

Further findings

OutcomeDLCMP value
C3 level, DLCM+ vs DLCM-0.71 g/LP < 0.001
Musculoskeletal involvement, DLCM55.3% vs 44.7%P < 0.01
  • C3 level, DLCM+ vs DLCM-: DLCM- 0.90 g/L

Agreement between methods (Cohen's kappa)

DLCM vs CLIA, substantial positive agreement
κ=0.67
IIF vs other methods, moderate agreement
κ=0.52-0.55

Moderate-severe disease activity

DLCM positive
65.0%

Renal involvement, diagnostic performance

Sensitivity
46.9%
Specificity
56.3%
AUC
0.52

Original publication

Clinical evaluation of the novel digital liquid chip method for anti-dsDNA detection in SLE. Lupus Sci Med. Published 15 July 2025. doi:10.1136/lupus-2025-001608

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