SLE-key® is a molecular diagnostic test developed by ImmunArray to support a physician’s ability to rule-out a diagnosis of Systemic Lupus Erythematosus (SLE). SLE-key® works by determining the pattern of circulating antibodies to an array of antigens which are printed on ImmunArray’s proprietary iCHIP®. This pattern is compared to SLE affected and healthy control patterns. Proprietary analytic algorithms are then used to determine the likelihood of the patient being affected with SLE, along with a probability score.
The validated SLE-key®, developed based on autoantibody fingerprints from 250 affected and 250 healthy females, has been shown to exclude SLE during differential diagnosis with >90% sensitivity and >70% specificity.