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® is a test to measure a patient’s SLE-specific antibody fingerprint and immune system activity.
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. 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.
ImmunArray’s iCHIP® technology detects this unique, and validated autoantibody signature/profile, which informs decision making during the diagnosis of SLE.
SLE-key® evaluates the immune system as a whole in a single test to support a decision to rule-out a diagnosis of SLE. Results are delivered to the physician within a few days.
SLE-key® may also be used by physicians to track their patients’ immune profiles over time to monitor changes in disease state and/or response to therapy.