BioPlex® 2200 ANA Screen with MDSS

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Overview

BioPlex® 2200 ANA Screen with MDSS

BioPlex® 2200 Medical Decision Support Software

The Medical Decision Support Software (MDSS) uses an interpretive algorithm trained with over 13,000 test results from a diverse cohort of over 1,100 clinically characterized patients. When used in conjunction with the ANA Screen, it is an optional laboratory tool that associates patient antibody results 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)
  • Polymyositis

BioPlex® 2200 ANA Screen with MDSS

ANA Screen Assay Procedure

An indirect assay format is used for the BioPlex® 2200 ANA Screen

1. Patient sample (5 µL) automatically added to
    reaction vessel

2. Sample diluent & beads added
    and incubated at 37°C

3. Wash step

4. Conjugate added and incubated at 37°C

5. Wash step

6. Bead resuspended in wash buffer

7. Flow-based, dual laser detection

BioPlex® 2200 ANA Screen with MDSS

Reagents, Calibrators, and Controls

ANA Screen Reagent Pack

Contains all the necessary reagents (sample diluent, beads, and conjugate) to process 100 patients and up to 12 results per patient.

 

   

ANA Screen Calibrator Set

Calibrators are ready-to-use and multiplexed. For dsDNA, a six-point 4PL fitted curve is used to calculate quantitative results. For the other analytes, a point-to-point curve fit using four calibrators is used to calculate semi-quantitative results.

   

ANA Screen Control Set

Quality controls are ready-to-use and multiplexed. The set includes a negative control as well as a multianalyte positive control containing antibodies to analytes within the ANA Screen Reagent Pack.

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.

BioPlex 2200 ANA Screen Calibrator Set
BioPlex 2200 ANA Screen Calibrator Set

663-1100
Set of multiplexed standard analytes for calibration of results of antinuclear autoantibody screening on BioPlex 2200 System

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BioPlex 2200 ANA Screen Control Set
BioPlex 2200 ANA Screen Control Set

663-1130
Multiplexed negative and multianalyte positive controls for antinuclear autoantibody screening on BioPlex 2200 System

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BioPlex 2200 ANA Screen Reagent Pack
BioPlex 2200 ANA Screen Reagent Pack

665-1150
Reagents for 100 tests for clinically relevant antinuclear autoantibodies on BioPlex 2200 System; aids in diagnosis of systemic rheumatic diseases

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