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

摘要

We describe here the development, verification and validation of the SLE-key (R) rule-out test for a definitive rule out of a diagnosis of systemic lupus erythematosus (SLE). The test uses the proprietary iCHIP (R) 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. (C) 2015 Elsevier B.V. All rights reserved.