BioPlex® 2200 ANA Screen with MDSS

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Overview

A multiplex assay for detection of clinically relevant antinuclear antibodies used in the diagnosis of systemic rheumatoid disease; software associates patient results with predefined profiles correlated with systemic autoimmune diseases
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Description

Description

The BioPlex® 2200 ANA Screen with MDSS detects clinically significant antibodies, providing the most relevant information for better diagnosis of systemic autoimmune diseases. Its multiplex technology permits simultaneous detection and identification of many antibodies in a single tube.

The system 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 individual antibodies (to chromatin, ribosomal-P protein, SS-A, SS-B, Sm, Sm/RNP, RNP, Scl-70, Jo-1, and centromere B) in human serum and/or EDTA or heparinized plasma. The ANA Screen detects the presence of clinically relevant circulating autoantibodies, which may be useful in diagnosing systemic rheumatoid diseases such as 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.

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 with predefined MDSS profiles that have been correlated with the following systemic autoimmune diseases: SLE, MCTD, SS, scleroderma, and polymyositis.

The BioPlex 2200 ANA Screen with MDSS is the only autoimmune diagnostic product cleared for use with an interpretive software algorithm.

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Reagents for 100 tests for clinically relevant antinuclear autoantibodies on BioPlex 2200 System; aids in diagnosis of systemic rheumatic diseases
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Multiplex calibrators for calibration of results of ANA Screen testing on the BioPlex 2200 System
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CD with software to verify calibration of ANA screening on BioPlex 2200 system
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Set of multiplex negative and multi-analyte positive controls for ANA testing on the BioPlex 2200 System
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CD with software to check performance of controls in ANA testing on the BioPlex 2200 system