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The BioPlex™ 2200 ANA Screen is intended for the qualitative screening of specific antinuclear antibodies (ANA), the quantitative detection of antibody to dsDNA, and the semi-quantitative detection of ten (10) separate antibody assays (Chromatin, Ribosomal Protein, SS-A, SS-B, Sm, SmRNP, RNP, Scl-70, Jo-1, and Centromere B) in human serum and/or EDTA or heparinized plasma. The ANA Screen is used to screen serum or plasma (EDTA, heparin) samples and detect the presence of antinuclear antibodies as an aid in the diagnosis of systemic autoimmune diseases (Systemic Lupus Erythematosus [SLE], Mixed Connective Tissue Disease [MCTD], Undifferentiated Connective Tissue Disease [UCTD], Sjögren's Syndrome [SS], Scleroderma [Systemic Sclerosis], Dermatomyositis, Polymyositis, Rheumatoid Arthritis [RA]. CREST Syndrome, and Raynaud's Phenomenon) in conjunction with clinical findings and other laboratory tests. The ANA Screen is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Medical Decision Support Software (MDSS), used in conjunction with the ANA Screen. is an optional laboratory tool that associates patient antibody results from the ANA Screen with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren's Syndrome (SS), Scleroderma (Systemic Sclerosis) and Polymyositis.

The BioPlex 2200 Medical Decision Support Software (MDSS) is a pattern recognition algorithm that can enhance the performance of the ANA Sercen by identifying associated diagnostic patterns among its multiple assay results. The MDSS can suggest one or more possible discase associations after identifying patterns from the cleven ( 1 ) individual antibody results. The MDSS is based on the principles of the "k-nearest neighbor" 11 (kNN) statistical technique. Each "unknown" is compared to a pre-established database that contains the results for over 1,400 characterized scrappasma. Results of MDSS analysis fall into one of the following general outcomes: Negative, No Association, or Association with Disease. When the results of the MDSS analysis fall into the Association with Disease category, the MDSS software will propose a maximum of two disease classifications based upon the similarity of the current analysis to the stored results. The MDSS output can also aid in determining appropriate additional autoimmune serological testing.