SLE-key(®) rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP(®)

J Immunol Methods. 2016 Feb:429:1-6. doi: 10.1016/j.jim.2015.12.003. Epub 2015 Dec 8.

Abstract

We describe here the development, verification and validation of the SLE-key(®) rule-out test for a definitive rule-out of a diagnosis of systemic lupus erythematosus (SLE). The test uses the proprietary iCHIP(®) micro-array technology platform (Fattal et al., 2010) to identify discriminating patterns of circulating autoantibodies among SLE patients compared with self-declared healthy individuals. Given the challenges associated with the diagnosis of SLE and the healthcare costs of delayed diagnosis and misdiagnosis, a definitive rule-out test can provide significant clinical benefits to patients and potentially major cost savings to healthcare systems.

Keywords: Autoantibodies; Diagnosis; ICHIP; Microarray; Multivariate classifier; Systemic lupus erythematosus.

Publication types

  • Research Support, N.I.H., Extramural
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Autoantibodies / blood
  • Autoantibodies / immunology
  • Female
  • Humans
  • Immunoassay*
  • Lupus Erythematosus, Systemic / blood
  • Lupus Erythematosus, Systemic / diagnosis*
  • Lupus Erythematosus, Systemic / immunology
  • Middle Aged
  • Protein Array Analysis / methods*
  • Serologic Tests / methods*
  • Young Adult

Substances

  • Autoantibodies