Syphilis IgG

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Overview

BioPlex™ 2200 Syphilis IgG

Overall Performance

Concordance: 433 results were obtained from pregnant women to assess positive and negative agreements
relative to a reference methodology. The BioPlex™ 2200 Syphilis IgG kit shows excellent correlation with the
reference method.

† Reference Assay: Combined results from commercially available RPR and TPPA assays. For discrepant results (between RPR and TPPA),
   a commercial treponemal EIA test was used for final interpretation.

Serum Samples
Requested to Be
Treponemal Positive
BioPlex 2200 Syphilis IgG
Reactive Equivocal Nonreactive Total Positive (+)
% Agreement
95%
Confidence
Interval
Reference Assay
Result
Positive 166 0 0 166 100%
(166/166)
97.7–100%
Equivocal 4* 0 0 4
Negative 8** 0 5 13
Total 178 0 5 183


 * Four (4) BioPlex 2200 Syphilis IgG reactive samples were RPR nonreactive, TPPA reactive, and treponemal EIA equivocal.
** Of eight (8) BioPlex 2200 Syphilis IgG reactive samples, 7 were RPR nonreactive, TPPA reactive, and treponemal EIA negative and
    1 sample was RPR and TPPA nonreactive.


Serum Samples
Requested to Be
RPR and TPPA
NonReactive
BioPlex 2200 Syphilis IgG
Reactive Equivocal Nonreactive Total Negative (–)
% Agreement
95%
Confidence
Interval
Reference Assay
Result
Positive 0 0 0 0 98.8%
(247/250)
96.5–99.6%
Equivocal 0 0 0 0
Negative 3* 0 247 250
Total 3 0 247 250

* Three (3) BioPlex 2200 Syphilis IgG reactive samples were RPR and TPPA nonreactive.

BioPlex™ 2200 Syphilis IgG

Performance in Medically Diagnosed Patients

Comparative Reactivity: 70 characterized samples from patients medically diagnosed with syphilis infection were tested for positive agreement and reactivity vs. the reference method. The BioPlex™ 2200 Syphilis IgG kit demonstrated a higher reactivity rate than the reference method on samples from patients previously diagnosed with syphilis.

Reactivity in Patients
BioPlex 2200 Syphilis IgG 95.7% (67/70)
Reference Method 90.0% (63/70)

Serum Samples
from Patients
Medically Diagnosed
with Syphilis Infection
BioPlex 2200 Syphilis IgG
Reactive Equivocal Non-reactive Total Positive (–)
% Agreement
95%
Confidence
Interval
Reference Assay
Result
Positive 63 0 0 63 100% (63/63) 94.2–100%
Equivocal 1* 0 0 1
Negative 3** 0 3 6
Total 67 0 3 70


 * One (1) sample with BioPlex 2200 Syphilis IgG reactive results was RPRnonreactive, TPPA reactive and treponemal EIA equivocal.
** Three (3) samples with BioPlex 2200 Syphilis IgG reactive results were RPRand TPPA nonreactive.

BioPlex™ 2200 Syphilis IgG

Precision

Following CLSI EP5-A guidelines, the BioPlex™ 2200 Syphilis IgG Kit demonstrated %CV values of less than 8.5% for total precision near cutoff levels. The Syphilis IgG Kit exhibits market-leading performance in precision, particularly when compared to competitive automated products that have average %CV up to 21%. The low %CV of the Bioplex Kit can be attributed to a) full automation, b) the magnetic bead, heterogenous assay format and c) a minimum of 150 measurements per analyte.

Syphilis IgG
Panel Members
Sample
N
Grand
Mean AI
Within-Run Between-Day Between-Run Total
SD %CV SD %CV SD %CV SD %CV
Near Cut-Off 1
Tp 15 kDa
80 1.0 0.04 3.5% 0.07 7.0% 0.03 3.1% 0.09 8.4%
Near Cut-Off 2
Tp 15 kDa
80 1.0 0.04 3.8% 0.06 6.5% 0.03 3.3% 0.08 7.8%
Near Cut-Off 1
Tp 17 kDa
80 1.0 0.03 3.3% 0.07 6.9% 0.03 3.1% 0.08 7.9%
Near Cut-Off 2
Tp 17 kDa
80 1.0 0.03 3.1% 0.05 5.3% 0.04 4.3% 0.08 7.3%
Near Cut-Off 1
Tp 47 kDa
80 1.1 0.03 2.4% 0.04 4.3% 0.03 3.0% 0.06 5.7%
Near Cut-Off 2
Tp 47 kDa
80 1.1 0.04 3.1% 0.05 4.8% 0.03 2.8% 0.07 6.4%
BioPlex™ 2200 Syphilis IgG

Syphilis IgG Assay Procedure

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 Syphilis IgG

Reagents, Calibrators, and Controls

Syphilis IgG Reagent Pack

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

Syphilis IgG Calibrator Set

Calibrators are ready-to-use and already barcoded for ease of use.

Syphilis IgG Control Set

Quality Controls are ready-to-use and already barcoded for ease of use.

The BioPlex® 2200 Syphilis IgG kit simultaneously detects three of the most clinically relevant antibodies directed against individual recombinant proteins to Treponema pallidum in a multiplex format. This kit is a multiplex flow immunoassay for the qualitative numeric detection of T. pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. It is also indicated for use in confirming reactive test results from non-treponemal based screening assays.

The BioPlex® 2200 Syphilis IgG kit delivers a composite result for a comprehensive examination of the causative agent. Reportable results include:

  • Syphilis IgG Composite*
  • Treponema pallidum 15 kDa**
  • Treponema pallidum 17 kDa**
  • Treponema pallidum 47 kDa**

   
Syphilis IgG Composite is a rollup of the individual results. 
**  Individual results available outside the US only. 

BioPlex<sup>®</sup> 2200 Syphilis IgG Calibrator Set
BioPlex® 2200 Syphilis IgG Calibrator Set

663-1400
Set of multiplexed standards for calibration of results of syphilis screening based on IgG antibodies on BioPlex® 2200 System

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Quantity:   Add to Quote
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BioPlex<sup>®</sup> 2200 Syphilis IgG Control Set
BioPlex® 2200 Syphilis IgG Control Set

663-1430
Two sets of multiplexed negative and multianalyte positive controls for syphilis screening based on IgG antibodies on BioPlex® 2200 System

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BioPlex<sup>®</sup> 2200 Syphilis IgG Reagent Pack
BioPlex® 2200 Syphilis IgG Reagent Pack

665-1450
Reagents for 100 tests for clinically relevant IgG antibodies to Treponema pallidum on BioPlex® 2200 System; aids the diagnosis of syphilis

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Quantity:   Add to Quote
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Number Description Options
T-115 BioPlex 2200 Syphilis IgG Brochure Click to download [ Add to Cart (Free) ]
T-136 BioPlex 2200 Panel Menu Click to download [ Add to Cart (Free) ]
T-159 BioPlex 2200 Syphilis IgG and IgM Brochure Click to download [ Add to Cart (Free) ]
T-167 BioPlex 2200 Infectious Disease Panels Brochure Click to download [ Add to Cart (Free) ]