This document addresses multiplex autoantigen microarray testing for the diagnosis and management of systemic lupus erythematosus (SLE), a chronic autoimmune disease. The technology involves simultaneous testing for multiple autoantibodies associated with SLE, and may involve use of a proprietary algorithm to determine a risk score. At least one manufacturer, Exagen, Inc., is marketing such tests in the United States; the SLE-key^® test (ImmunArray) is not currently available. The document does not address panels of individual tests for evaluating SLE.

Position Statement

Investigational and Not Medically Necessary:

Multiplex autoantigen microarray testing to screen for, diagnose, or manage systemic lupus erythematous is considered investigational and not medically necessary.