BioPlex® 2200 Vasculitis

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Overview

BioPlex™ 2200 Vasculitis

Comparison with EIA Methods

Positive Agreement

A total of 227 retrospective samples positive for anti-MPO (N = 100), anti-PR3 (N = 100) and anti-GBM (N = 27) were testedwith the BioPlex™ 2200 Vasculitis Kit and the corresponding commercially available microplate EIA methods. Thepositive % agreement and overall % agreement between the two methods for each analyte are referenced in thetable below. The BioPlex 2200 Vasculitis Kit demonstrated good positive agreement with commerciallyavailable EIA assays for each analyte.

  BioPlex 2200 Vasculitis Anti-MPO Result BioPlex 2200 Vasculitis Anti-PR3 Result BioPlex 2200 Vasculitis Anti-GBM Result
  Positive % Agreement Overall % Agreement Positive % Agreement Overall % Agreement Positive % Agreement Overall % Agreement
EIA Result
Retrospective Samples Positive for Anti-MPO, Anti-PR3 and Anti-GBM
93.9% (92/98) 93.0% (93/100)* 100% (79/79) 83.0% (83/100) 88.9% (16/18) 92.6% (25/27)

* One (1) anti-MPO EIA equivocal result is included in the Overall Agreement.
Ten (10 anti-PR3 EIA equivocal results are included in the Overall Agreement.
Two (2) of the sixteen (16) BioPlex 2200 anti-GBM positive results were weak positives by anti-GBM EIA.
One (1) of the two (2) BioPlex 2200 anti-GBM negative results was a weak positive by anti-GBM EIA.


Negative Agreement

A total of 293 samples from normal blood donors and 300 samples from unselected patient samples previously tested with vasculitis tests were tested with the BioPlex 2200 Vasculitis kit and the corresponding commercially available microplate EIA methods. The negative % agreement and overall % agreement between the two methods for each analyte are referenced in the table below. The BioPlex 2200 Vasculitis kit demonstrated excellent negative agreement with commercially available EIA assays for each analyte.

  BioPlex 2200 Vasculitis
Anti-MPO Result
BioPlex 2200 Vasculitis
Anti-PR3 Result
BioPlex 2200 Vasculitis Anti-GBM Result
  Negative % Agreement Overall % Agreement Negative % Agreement Overall % Agreement Negative % Agreement Overall % Agreement
EIA Result
Normal Blood Donors
100% (293/293) 100% (293/293) 100% (293/293) 100% (293/293) 93.3% (289/291) 98.6% (289/293)
EIA Result
Unselected Patient Samples*
97.6% (284/291) 96.3% (289/300) 99.0% (292/295) 99.0% (297/300) 99.7% (298/299) 99.3% (298/300)


* Previously tested with vasculitis tests.


Positive Agreement

A total of 200 retrospective positive samples (100 anti-MPO and 100 anti-PR3) were evaluated by a commercially available ANCA IFA method using ethanol-fixed slides. The positive agreement and overall agreement between the two methods are referenced in the tables below. The BioPlex 2200 Vasculitis Kit demonstrated good positive agreement with the ANCA IFA method.

  BioPlex 2200
Anti-MPO Result
  Positive % Agreement Overall % Agreement
pANCA IFA Result
Retrospective Samples
Positive for Anti-MPO
93.3% (83/89) 84.0% (84/100)

  BioPlex 2200
Anti-PR3 Result
  Positive % Agreement Overall % Agreement
pANCA IFA Result
Retrospective Samples
Positive for Anti-PR3
94.9% (93/98) 93.0% (93/100)

BioPlex 2200 Vasculitis vs. EIA Methods

For the 200 retrospective positive samples described above, a combined positive agreement of 94.1% was observed between BioPlex 2200 Vasculitis anti-MPO/anti-PR3 and ANCA IFA results, compared to a combined positive agreement of 88.2% between anti-MPO/anti-PR3 EIA and ANCA IFA results. Also, a combined overall agreement with ANCA IFA results of 88.5% and 83.0% was observed between BioPlex 2200 and EIA results, respectively. Overall, the BioPlex 2200 Vasculitis Kit demonstrated better concordance with ANCA IFA than the corresponding EIA methods.

  Combined BioPlex 2200
Anti-MPO/Anti-PR3 Results
Combined
Anti-MPO/Anti-PR3 EIA Results
  Positive %
Agreement
Overall %
Agreement
Positive %
Agreement
Overall %
Agreement
Combined
p-/c-ANCA
IFA Results
94.1%
(176/187)
88.5%
(177/200)
88.2%
(165/187)
83.0%
(166/200)
BioPlex™ 2200 Vasculitis

Reproducibility

Following CLSI (formerly NCCLS) EP5-A2 guidelines and ISO/TR 22971:2005, two (2) US testing sites and an internal site performed reproducibility testing using the BioPlex™ 2200 vasculitis positive control for 3 days with a total of 36 replicates. The overall performance demonstrated excellent reproducibility ranging from 0.0% to 7.7%.

The low %CV values on the BioPlex™ 2200 Vasculitis Kit can be attributed to:

  • Full automation
  • Magnetic bead, heterogeneous assay format
  • A minimum of 150 measurements per analyte per reaction vessel (up to 3 times more than other multiplex methods)
  Within-Run Between-Run Total
Positive Control Sample (N) Grand Mean AI SD %CV SD %CV SD %CV
Anti-MPO 36 2.9 0.198 6.8% 0.000 0.0% 0.223 7.7%
Anti-PR3 36 2.3 0.134 5.8% 0.000 0.0% 0.167 7.3%
Anti-GBM 36 2.8 0.139 4.9% 0.000 0.0% 0.153 5.4%
BioPlex® 2200 Vasculitis

Vasculitis Assay Procedure

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 Vasculitis

Reagents, Calibrators and Controls

Vasculitis Reagent Pack

Contains all the necessary reagents (sample diluent, beads, and conjugate) to process 100 samples and up to 3 results per sample.

 

Vasculitis Calibrator Set

Calibrators are ready-to-use and multiplexed. A point-to-point curve fit using four calibrators is used to calculate semi-quantitative results.

Vasculitis 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 Reagent Pack.

BioPlex™ 2200 Vasculitis is the first and only fully automated, random access multiplexed solution that detects the most clinically relevant antibodies associated with systemic small vessel vasculitis: anti-MPO, anti-PR3, and anti-GBM.

This multiplex flow immunoassay is intended for the semi-quantitative detection of IgG autoantibodies to myeloperoxidase (MPO), proteinase 3 (PR3) and glomerular basement membrane (GBM) in human serum. In conjunction with clinical findings, the test system is used as an aid in the diagnosis of anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides: microscopic polyangiitis (MPA), necrotizing glomerulonephritis, Churg-Strauss syndrome, Wegener’s granulomatosis, and the autoimmune renal disorder Goodpasture’s syndrome.

BioPlex 2200 Vasculitis Reagent Pack
BioPlex 2200 Vasculitis Reagent Pack

665-1850
Reagents for 100 tests for anti-MPO, anti-PR3, and anti-GBM; aids in diagnosis of autoimmune vasculitides and Goodpasture’s syndrome

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BioPlex 2200 Vasculitis Calibrator Set
BioPlex 2200 Vasculitis Calibrator Set

663-1800
Multiplexed standard analytes for calibration of results of vasculitis screening on BioPlex 2200 system

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BioPlex 2200 Vasculitis Calibrator CD
BioPlex 2200 Vasculitis Calibrator CD

663-1820
CD with software to verify calibration of vasculitis screening on BioPlex 2200 system

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BioPlex 2200 Vasculitis Control Set
BioPlex 2200 Vasculitis Control Set

663-1830
Set of multiplexed negative and multianalyte (anti-MPO, anti-PR3, anti-GBM) positive controls for vasculitis testing on BioPlex 2200 System

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BioPlex 2200 Vasculitis Control CD
BioPlex 2200 Vasculitis Control CD

663-1840
CD with software to check performance of controls in vasculitis screening on BioPlex 2200 System

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Number Description Options
T-128 BioPlex 2200 Vasculitis Product Sheet Click to download [ Add to Cart (Free) ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart (Free) ]
T-169 BioPlex 2200 Autoimmune Panels Brochure Click to download [ Add to Cart (Free) ]
T-146 BioPlex 2200 Vasculitis Kit Product Sheet Click to download [ Add to Cart (Free) ]