Intended Use: QUANTA Lite™ ssDNA ELISA is a semi-quantitative Enzyme-Linked Immunosorbent Assay (ELISA) for the detection of anti-single stranded DNA (ssDNA) autoantibodies. The INOVA QUANTA Lite™ ssDNA ELISA kit when used in conjunction with the INOVA QUANTA Lite™ dsDNA kit is designed for the semi-quantitative determination of ssDNA autoantibodies in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases. The test is not definitive by itself but is one parameter in a multicriterion diagnostic process.
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