BioPlex® 2200 ANA Screen with MDSS

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Overview

BioPlex™ 2200 ANA Screen with MDSS

Comparison with EIA-Specific Methods

BioPlex™ 2200 ANA Screen vs. Manual EIA

Prospective patient samples were tested for specific autoantibodies with both.

Antibody N = 908 Positive Samples Negative Samples % Overall Agreement
ANA Screen 351 369 79.3%
dsDNA* 108 724 94%
Chromatin 158 750 86%
Ribosomal Protein 21 887 98%
SS-A 170 738 97%
SS-B 69 839 97%
Sm 40 868 97%
Sm/RNP 113 795 96%
RNP* 95 784 95%
Scl-70 17 891 98%
Jo-1 11 897 99%
Centromere B 32 876 99%


* dsDNA N = 832 samples with RNP N = 879 samples

BioPlex™ 2200 ANA Screen with MDSS

Comparison of dsDNA External Standard

WHO W/o 80 Standard

Testing was conducted to assess the quantitation claims of the BioPlex™ 2200 ANA Screen dsDNA assay results. This was carried out using the WHO W/o 80 external standard. Dilution linearity was confirmed with a correlation coefficient of greater than 99.9%.

BioPlex™ 2200 ANA Screen with MDSS

Reproducibility

BioPlex™ 2200 ANA Screen

Following CLSI EP5-A guidelines, the BioPlex 2200 ANA Screen positive control was run for 10 days for a total of 40 replicates at one clinical site. Overall performance showed intra-assay (within-run) precision between 2.5 and 4.7% CV and inter-assay (between-run) precision between 6.8 and 8.6% CV. This shows excellent reproducibility compared to other multiplex assays, whose inter-assay %CVs range from 5.5 to 42.8%. The low CVs on the BioPlex 2200 ANA Screen can be attributed to a) full automation, b) the magnetic bead, heterogenous format of the assay and c) 200 measurements per analyte (up to 4 times those of other multiplex methods).

N = 40, Site 2 dsDNA (IU/ml) Chromatin (AI) Ribo-P (AI) SS-A 52 (AI) SS-A 60 (AI) SS-B (AI) Sm (AI) Sm/RNP (AI) RNP A (AI) RNP 68 (AI) Scl-70 (AI) Jo-1 (AI) Centromere B (AI)
Mean 24.7 2.3 2.7 2.8 2.8 3.8 3.0 2.7 2.9 3.4 2.4 3.6 2.4
Intra-Assay %CV 2.9 4.1 2.5 4.7 3.5 3.1 3.0 2.5 3.8 4.2 3.2 3.8 3.7
Inter-Assay %CV 7.0 8.3 7.1 8.6 7.3 8.4 7.8 6.8 8.4 8.6 7.3 8.2 8.6
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 15,000 test results from a diverse cohort of over 1,400 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 (dilution 1:60) 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 (14 outside of the U.S.) 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 autoimmune diseases

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Number Description Options
T-101 BioPlex 2200 ANA Screen Brochure Click to download [ Add to Cart (Free) ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart (Free) ]
T-156 BioPlex 2200 ANA Screen with MDSS Sales Sheet Click to download [ Add to Cart (Free) ]
T-169 BioPlex 2200 Autoimmune Panels Brochure Click to download [ Add to Cart (Free) ]