Detect Lyme Disease Earlier

With BioPlex 2200 Lyme Total Assay*

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Lyme Total Assay

Don't Miss the Opportunity With Our New and Improved BioPlex 2200 Lyme Total Assay

The BioPlex 2200 Lyme Total assay detects Lyme disease at every stage of infection. Engineered to target Total (IgG/IgM) antibodies to Borrelia burgdorferi, this screening assay is an effective solution for laboratories to provide accurate information about patients' Lyme disease status.

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Learn more about the BioPlex 2200 Lyme Total Assay

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Sensitivity

Sensitivity

Highly sensitive for acute, convalescent, and late stages of infection, so patients can be more confident in the accuracy of their Lyme screen results.

The BioPlex 2200 Lyme Total assay was designed to include multiple Lyme disease targets expressed in the earliest stages of Lyme infection.

This assay:

  • is highly sensitive for all stages of Lyme disease so patients are identified and treated even when recently infected
  • improves on existing Lyme disease testing assays

Sensitivity data is from the CDC LSR Premarketing Panel and does not imply an endorsement by the CDC.

Graphic lyme ticks

Lyme disease can be contracted anywhere - on vacation or even in your own backyard. The BioPlex 2200 Lyme Total assay can inform people if they have contracted Lyme, regardless of where they were exposed to the disease.

Specific and Targeted Detection

Specificity

The BioPlex 2200 Lyme Total assay identifies more specific targets to Lyme disease by leveraging a modified VlsE antigen which reduces cross-reactivity and improves specificity.

Graphic 96.8% agreement with CDC Panel

We were able to pick out spots of these proteins that were very specific to the Lyme disease bacteria... Bio-Rad was able to take that technology and further develop it and produce a test that is now available in clinical laboratories... [the BioPlex 2200 Lyme Total assay] should start to revolutionize Lyme testing for everybody.

Raymond Dattwyler, M.D. describing how his lab's work was used by Bio-Rad to create the BioPlex 2200 Lyme Total assay

Testing for Cross-Reactivity with Diseases Similar to Lyme

The BioPlex 2200 Lyme Total assay was tested against a CDC panel of "look-alike diseases" known to cross-react in other Lyme disease testing assays.

The BioPlex 2200 Lyme Total assay showed low cross-reactivity and is unlikely to report a positive Lyme result if a patient is actually infected with a disease tested in this panel.

Sample Type % Agreement
with CDC Panel
Look-Alike Diseases
 Fibromyalgia
(n=15)		 93.3%
Mononucleosis
(n=15)		 86.7%
Multiple sclerosis
(n=15)		 100%
Periodontitis
(n=15)		 100%
Rheumatoid arthritis
(n=15)		 100%
Syphilis
(n=15)		 100%
Healthy
Controls
 Non-Endemic
(n=50)		 98.0%
Endemic
(n=50)		 96.0%
Overall Specificity (n=190) 96.8%

Specificity data is from the CDC LSR Premarketing Panel and does not imply an endorsement by the CDC.

Head-to-Head Comparisons

The BioPlex 2200 Lyme Total assay was compared with three top-selling competitor Lyme disease screening assays using the CDC LSR Premarketing Panel of well-characterized Lyme disease samples.

Evaluation of Overall Clinical Sensitivity & Specificity

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Evaluation of Sensitivity

in 3 disease stages

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BioPlex 2200 Lyme Total Competitor 1 Competitor 2 Competitor 3
Overall Sensitivity (n=90) 91.1% 85.6%** 88.9% 86.7%
Disease Stage
 Acute
(n=39)		 84.6% 79.5% 82.1% 74.4%
Convalescent
(n=31)		 93.5% 83.9% 90.3% 93.5%
Late
(n=20)		 100% NA* 100% 100%

*Material not sufficient to test
**Overall sensitivity calculated with an assumed 100% late sensitivity

Evaluation of Specificity

against look-alike diseases and healthy controls

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BioPlex 2200 Lyme Total Competitor 1 Competitor 2 Competitor 3
Overall Specificity (n=190) 96.8% 84.7% 89.5% 96.8%
Look-Alike Diseases
 Fibromyalgia
(n=15)		 93.3% 86.7% 93.3% 100%
Mononucleosis
(n=15)		 86.7% 60% 73.3% 86.7%
Multiple sclerosis
(n=15)		 100% 93.3% 80% 100%
Periodontitis
(n=15)		 100% 86.7% 100% 100%
Rheumatoid arthritis
(n=15)		 100% 86.7% 100% 100%
Syphillis
(n=15)		 100% 80% 80% 93.3%
Healthy
Controls
 Non-Endemic
(n=50)		 98% 86% 88% 98%
Endemic
(n=50)		 96% 88% 94% 96%

Multiplex Immunoassay Design

Designed to Detect Early and Late Stage Lyme Disease

The BioPlex 2200 Lyme Total assay is highly engineered to detect IgG and IgM antibodies to Borrelia burgdorferi in human serum or plasma for all stages of Lyme disease.

Multiplex Immunoassay

3 Beads Detect 4 Different Targets

By leveraging Bio-Rad's multiplexed technology, the BioPlex 2200 Lyme Total assay is able to detect multiple Lyme disease targets - resulting in a greater number of opportunities to detect Lyme disease in a patient's sample. All of our targets were selected for their ability to identify patients early in their Lyme disease infection. The modified FVlsE was added to also identify patients in the later stages of infection.

Learn more  graphic detection beads

BioPlex 2200 for Lyme Disease Testing

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Efficiency

  • High throughput - 100 samples/hr
  • Fully automated random access
  • Multiplex chemistry for increased sensitivity and specificity
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Simplicity

  • Total assay - one test for both IgG and IgM antibodies to Lyme disease
  • Intuitive software with touchscreen interface and bidirectional connection to your LIS
  • Ready-to-use multiplex calibrators and controls to reduce hands-on time and labor costs
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Quality

Integrated quality assurance with two internal QC beads

  • Serum verification bead (SVB) confirms presence of serum/plasma sample
  • Internal standard bead (ISB) standardizes detector performance
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*The BioPlex 2200 Total Lyme assay is only available in the U.S. and Canada