title: SLE-key(®) rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP(®).
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.
authors.affiliation: Division of Rheumatology, Albert Einstein College of Medicine, NY, United States. Electronic address: chaim.putterman@einstein.yu.edu.
authors.forename: Chaim
authors.initials: C
authors.lastname: Putterman
authors.affiliation: Department of Laboratory Medicine, San Francisco General Hospital, CA, United States.
authors.forename: Alan
authors.initials: A
authors.lastname: Wu
authors.affiliation: ImmunArray Ltd., Rehovot, Israel; Department of Statistics, University of Haifa, Haifa, Israel.
authors.forename: Anat
authors.initials: A
authors.lastname: Reiner-Benaim
authors.affiliation: ImmunArray Inc., VA, United States.
authors.forename: D Scott
authors.initials: DS
authors.lastname: Batty
authors.affiliation: Division of Rheumatology, Emory University School of Medicine, GA, United States.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Sanz
authors.affiliation: Division of Rheumatology & Immunology, Medical University of South Carolina, SC, United States.
authors.forename: Jim
authors.initials: J
authors.lastname: Oates
authors.affiliation: ImmunArray Ltd., Rehovot, Israel.
authors.forename: Keren
authors.initials: K
authors.lastname: Jakobi
authors.affiliation: Division of Rheumatology, Johns Hopkins University School of Medicine, MD, United States.
authors.forename: Michelle
authors.initials: M
authors.lastname: Petri
authors.affiliation: ImmunArray Ltd., Rehovot, Israel.
authors.forename: Pennina
authors.initials: P
authors.lastname: Safer
authors.affiliation: Gerwien Statistical Consulting, United States.
authors.forename: Robert
authors.initials: R
authors.lastname: Gerwien
authors.affiliation: ImmunArray Ltd., Rehovot, Israel.
authors.forename: Rachel
authors.initials: R
authors.lastname: Sorek
authors.affiliation: ImmunArray Ltd., Rehovot, Israel.
authors.forename: Yakov
authors.initials: Y
authors.lastname: Blumenstein
authors.affiliation: Weizmann Institute of Science, Rehovot, Israel.
authors.forename: Irun R
authors.initials: IR
authors.lastname: Cohen
mesh_terms: D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000097:blood / Q000276:immunology; D005260:Female; D006801:Humans; D007118:Immunoassay; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D008875:Middle Aged; D040081:Protein Array Analysis / Q000379:methods*; D012698:Serologic Tests / Q000379:methods*; D055815:Young Adult
chemical_list: D001323:Autoantibodies
keywords: Autoantibodies; Diagnosis; ICHIP; Microarray; Multivariate classifier; Systemic lupus erythematosus