Intended Use:
QUANTA Lite™ ANA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-nuclear antibodies (ANA) in human serum. The presence of ANA can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of rheumatic diseases such as systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The assay collectively detects, in one well, total ANA against chromatin (dsDNA and histones), Sm/RNP, SS-A, SS-B, Scl-70, centromere and PCNA as well as antibodies against diagnostically important cytoplasmic antigens such as Jo-1, mitochondria (M-2) and ribosomal-P protein. Sera positive for unidentified antigens by the traditional indirect immunofluorescent antibody test on HEp-2 cells may also be detected.