Intended Use:
QUANTA Lite™ Histone is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of histone antibodies in human serum. The presence of histone antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of Systemic Lupus Erythematosus (SLE), drug induced SLE and related connective tissue diseases, such as rheumatoid arthritis, dermatomyositis and Sjögren's Syndrome. Determination of the patient's histone antibody status may be useful in the differential diagnosis between SLE and drug induced SLE.