AVISE Lupus

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AVISE® Lupus is a 10-marker diagnostic test designed to aid healthcare providers in a timely diagnosis of patients with suspected Systemic Lupus Erythematosus (SLE).

What is included in AVISE Lupus?
Biomarkers AVISE Lupus AVISE CTD
10-marker Lupus diagnostic test containing Cell-Bound Complement Activation Products (CB-CAPs)
X
X
AVISE Index Calculation Value
X
X
Extractable Nuclear Antigen (ENA) Panel
X
Rheumatoid Arthritis Panel
X
Antiphospholipid Syndrome – APS Panel
X
Thyroid Panel
X
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Sample Test Report
AVISE® Lupus is the only lupus test that incorporates Cell-Bound Complement Activation Products (CB-CAPs) assays which have been shown to have higher sensitivity for diagnosing SLE than C3/C4 levels.
  • 22% greater sensitivity than C3/C4
  • 33% greater sensitivity than anti-dsDNA
  • 52% greater sensitivity than anti-Smith
This proprietary test also allows for the efficient measurement of essential markers simultaneously and has the opportunity to reduce inconsistencies in diagnostic workups and standardize test results.
AVISE Lupus has the potential to improve the diagnostic landscape for SLE by:
  • Improving accuracy by using assays with greater sensitivity and specificity
  • Standardizing diagnostic approach through conducting tests simultaneously and combining results into a single index score
  • Allowing for earlier diagnosis and thus mitigating downstream organ involvement
Sample Test Report

What is included in AVISE Lupus?
Biomarkers AVISE Lupus AVISE CTD
10-marker Lupus diagnostic test containing Cell-Bound Complement Activation Products (CB-CAPs)
X
X
AVISE Index Calculation Value
X
X
Extractable Nuclear Antigen (ENA) Panel
X
Rheumatoid Arthritis Panel
X
Antiphospholipid Syndrome – APS Panel
X
Thyroid Panel
X
AVISE Lupus, consisting of proprietary CB-CAPs and a unique two-tier algorithm, has been shown to improve physician diagnostic confidence, particularly in hard-to-diagnose patients.

What is included in AVISE Lupus?
Biomarkers AVISE Lupus AVISE CTD
10-marker Lupus diagnostic test containing Cell-Bound Complement Activation Products (CB-CAPs)
X
X
AVISE Index Calculation Value
X
X
Extractable Nuclear Antigen (ENA) Panel
X
Rheumatoid Arthritis Panel
X
Antiphospholipid Syndrome – APS Panel
X
Thyroid Panel
X
How does the AVISE Lupus algorithm work?

AVISE Lupus is a multi-marker algorithmic assay that delivers an index score indicative of SLE likelihood. Our proprietary two-tier algorithm integrates CB-CAPs together with autoantibody levels to provide a balanced diagnostic result with 80% sensitivity and 86% specificity for the diagnosis of SLE.

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  • anti-dsDNA
  • anti-Smith
  • EC4d or BC4d levels (meeting strong positive criteria)
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Tier-two provides an index score and assessment aggregated based upon three components: ANA, CB- CAPs, and autoantibody specificity. Tier-two includes the specificity component to increase performance in differentiating SLE from related autoimmune diseases. Key components of the assay include:
  • ANA
  • EC4d
  • BC4d
  • Autoantibody specificity components (anti-CCP, anti-SS-B/La, CENP, Jo-1, and Scl-70)

CB-CAPs Provide Increased Accuracy

CB-CAPs, Cell-Bound Complement Activation Products,  are complement split products bound to blood cells and include C4d bound to B cells (BC4d), erythrocytes (EC4d), and platelets (PC4d).

AVISE Lupus is the only validated SLE test that incorporates CB-CAPs assays which have been shown to have higher sensitivity for diagnosing SLE than C3/C4, anti-dsDNA, and anti-Smith.

 
AVISE Lupus provides physicians with greater confidence in diagnostic and treatment decisions than standard diagnostic lab tests. The AVISE Lupus test prompts early initiation of appropriate medication, thereby mitigating the potential for irreversible organ damage and associated decrease in patient quality of life.
Read The Science - CAPSTONE Study

References:

  1. Cell-bound complement activation products in SLE. Ramsey-Goldman R, et al. Lupus Science and Medicine. 2017.
  2. Cell-bound complement activation products in systemic lupus erythematosus: comparison with anti-double-stranded DNA and standard complement measurements. Putterman C. et al. Lupus Science and Medicine. 2014.
  3. Systemic lupus erythematosus and primary fibromyalgia can be distinguished by testing for cell-bound complement activation products. Wallace D. et al. Lupus Science & Medicine. 2016.
  4. The AVISE Lupus Test and Cell-bound Complement Activation Products Aid the Diagnosis of Systemic Lupus Erythematosus. Mossell J. et al. The Open Rheumatology Journal. 2016.