Lupus & antiphospholipid syndrome

Reference intervals for anticardiolipin (aCL) and anti-β2GPI immunoglobulin A, G and M (IgAGM) antibodies in a large health-inspection population: a foundational study for combined-isotype assay interpretation

Lupus Sci MedPublished Cross-sectional study

Authors' conclusion

Assay-specific 99th-percentile reference intervals for aCL IgAGM and anti-β2GPI IgAGM were established in a large health-inspection population and a physiologically normal reference subgroup.

Study context

Population
Individuals undergoing health inspection (5170 male, 2676 female; age 15–90 years); retrospective systemic lupus erythematosus (SLE) and coronary heart disease (CHD) populations with historical IgAGM results
Participants
7,846 vs 989
Exposure
Health-inspection population vs Physiologically normal reference subgroup
  • Health-inspection populationn = 7,846
  • Physiologically normal reference subgroupn = 989
Outcome
99th-percentile reference intervals for aCL IgAGM and anti-β2GPI IgAGM (ELISA)
Methodological detailsreference interval study, 99th-percentile reference intervals, retrospective contextual analyses in SLE and CHD
  • Reference interval study
  • 99th-percentile reference intervals
  • Retrospective contextual analyses in SLE and CHD

Main finding

As reported in the abstract

aCL IgAGM 99th percentile, all 7846 individuals

35.4 RU/mL

Anti-β2GPI IgAGM 99th percentile, all 7846 individuals

51.7 RU/mL

aCL IgAGM 99th percentile, physiologically normal reference subgroup

23.33 RU/mL

Anti-β2GPI IgAGM 99th percentile, physiologically normal reference subgroup

46.25 RU/mL

Observational data: associations, not effects.

Further findings

OutcomeEstimateP value
Anti-β2GPI above cut-off, SLE vs CHD (retrospective)SLE vs CHDproportion above general health participant cut-off 11.4% vs 4.5%P = 0.0425
Anti-β2GPI above cut-off, SLE vs CHD (retrospective)SLE vs CHDproportion above physiologically normal cut-off 12.3% vs 4.5%P = 0.0200

Sex and age differences

Sex differences significant for both antibodies in the overall population and in the physiologically normal subgroup
aCL showed age-related increases at the upper tail

Anti-β2GPI above cut-off, SLE vs CHD (retrospective)

SLE showed higher proportions above all four cut-offs than CHD

Exploratory: antibody levels and triglyceride-related profiles

Antibody levels linked to triglyceride-related profiles
  • Exploratory

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Reference intervals for aCL and anti-β2GPI IgAGM antibodies in a large health-inspection population: a foundational study for combined-isotype assay interpretation. Lupus Sci Med. Published 7 May 2026. doi:10.1136/lupus-2025-001889

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