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

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

Author information

1
Division of Rheumatology, Albert Einstein College of Medicine, NY, United States. Electronic address: chaim.putterman@einstein.yu.edu.
2
Department of Laboratory Medicine, San Francisco General Hospital, CA, United States.
3
ImmunArray Ltd., Rehovot, Israel; Department of Statistics, University of Haifa, Haifa, Israel.
4
ImmunArray Inc., VA, United States.
5
Division of Rheumatology, Emory University School of Medicine, GA, United States.
6
Division of Rheumatology & Immunology, Medical University of South Carolina, SC, United States.
7
ImmunArray Ltd., Rehovot, Israel.
8
Division of Rheumatology, Johns Hopkins University School of Medicine, MD, United States.
9
Gerwien Statistical Consulting, United States.
10
Weizmann Institute of Science, Rehovot, Israel.

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

PMID:
26678162
PMCID:
PMC4824168
DOI:
10.1016/j.jim.2015.12.003
[Indexed for MEDLINE]
Free PMC Article

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