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The BioArray Solutions ENA IgG BeadChip™ Test System is intended for use in testing human serum for the presence of human IgG class antibodies to six extractable nuclear antigens, SSA, SSB, Sm, Sm/RNP, Scl-70, and Jo-1. The presence of these autoantibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, scleroderma and myositis. This ENA IgG BeadChip is for use with Array Imaging System 400 (AIS400). This test is for in vitro diagnostic use.

The ENA IqG BeadChip™ Test System is a randomly encoded microarray-based immunoassay for antibodies to extractable nuclear antigens. The device is designed to detect IgG class antibodies in human serum to six extractable nuclear antigens: SSA, SSB, Sm, RNP/Sm, Jo-1, and SCL-70. Each antigen is covalently immobilized to a spectrally distinguishable bead type. A and of bead types is constructed by mixing all of the bead types of interest including antigen beads, positive control beads, negative control beads, and system control beads. The bead mixture is immobilized as a BeadChip™ microarray on a silicon chip allowing for the simultaneous detection of the auto-antibodies of interest by the AIS 400.