Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: Anti-double stranded deoxyribonucleic acid– Level 1 DNA* ,Anti-Sjögren’s Syndrom antigen A - 60 kDa. SS-A 60, Anti-Sjögren’s Syndrom antigen A - 52 kDa SS-A 52 ,Anti-Sjögren’s Syndrom antigen B SS-B, Anti-Smith antigen Sm ,Anti-Smith and ribonucleoproteins antigens Sm/RNP ,Anti- U1 ribonucleoproteins antigen U1RNP .
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen.