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IBDX® Serology Panel: ACCA IgA, ALCA IgG, AMCA IgG & gASCA IgG
Powerful Serological Markers Delivering Higher Sensitivity, Specificity, Predictive Value
compared to ASCA Identification for CD & IBD
Glycomind's IBDX serology test provides the most accurate, reliable and cost-effective serological blood testing available in the market for Inflammatory Bowel Disease (IBD) diagnosis, stratification (CD vs. UC) and Crohn's Disease severity prognosis.
IBDX leverages improved sensitivity and specificity based on 4 powerful microbial, glycan-based, serological biomarkers. ALCA, ACCA and AMCA, IBDX's novel glycan-antigens - working together with gASCA, Glycominds' second generation and improved mannan antigen (gASCA) - deliver superior results due to IBDX's unique sugar chemistry definitions and innovative proprietary panel of gastro markers.
IBDX in conjunction with pANCA enables the identification of early stage IBD patients, while differentiating between CD and UC with an overall diagnostic accuracy rate of 80% and identifies CD patients at risk for more aggressive disease behavior. IBDX's serological testing is comprised of the patented and proprietary glycan markers: ALCA, ACCA, AMCA, as well as an advanced gASCA test.
IBDX Panel Benefits & Features:
- Higher sensitivity: ~ 80% sensitivity, more than any other kit due to unique sugar chemistry and innovative panel of gastro markers.
- Higher specificity: Employing gASCA in combination with ALCA, ACCA and AMCA allows 95-99% specificity for IBD and Crohn's Disease.
- Identifies ASCA-negative Crohn's Disease patients: AMCA, ALCA & ACCA can identify 30-45% of ASCA-negative CD patients.
- High positive predictive value: All assays are convenient and reliable for specific screening and monitoring of risk groups.
5 Serological Markers Providing Comprehensive, Crohn's Disease Testing
CD is a complex, multi-factorial disease and a one marker serological test cannot deliver an accurate diagnosis. Glycominds' IBDX panel delivers a full picture of the pathogenesis of Crohn's Disease and its course in individual patients due to the IBDX panel's 5 clinical-in-the-field proven serological markers.
IBDX Panel: Major Prognostic Benefits & Features:
Implementing Glycomind's IBDX serology panel testing, at any stage in the analysis of patients' disease characterization work-ups, provides highly accurate additional information for clearer diagnosis and disease prognosis. This enhances the ability to offer patients the very best in individualized and effective treatment for their disease.
IBDX panel testing is an excellent tool for making decisions regarding IBD and CD patients:
- Over 90% positive prediction value (PPV - The percentage that positive results are correct) for IBD diagnosis when compared with other GI diseases based on Gold Standard i.e. predictive values are high for rule-in situations
- Over 85% PPV for the differentiation between CD and UC
- Higher Risk for more aggressive disease course (Hazard Ratio is 2-4) for CD patients with two or more positive IBDX markers
Additional Prognostic Benefits:
- CD severity
The IBDX panel predicts severity and complications of CD (strictures, fistulas and the need for surgery). Additionally, the panel is an excellent aid for the selection of appropriate treatment options (i.e. - steroid reduction, the use of biologicals if and when required…).
- Crohn's disease improved diagnostics including Family Screening
IBDX panel enables the identification of CD patients at higher sensitivity and specificity and even predicts CD patients before clinical symptoms.
- Pediatric and Young Patients Testing
IBDX is a simple, non-invasive solution ideal for testing pediatric and young sufferers of Crohn's Disease.
- High sensitivity for CD
~ 80% sensitivity for CD more than any other kit due to unique sugar chemistry and an innovative panel of gastro markers.
- High specificity for CD
Employing gASCA in combination with ALCA, ACCA and AMCA allows for 95-99% specificity.
- Identifies ASCA negative Crohn's Disease patients
ALCAACCA and AMCA can help identify 30-45% of ASCA negative CD patients.
- High positive predictive value
All IBDX assays are convenient and reliable for specific screening and monitoring of high risk groups.
- Prediction value
IBDX enables the prediction of whether patients are CD sufferer's months before clinical symptoms materialize, and can be used already at onset. Prediction of CD complications and surgery: Recent studies have demonstrated that gASCA, ACCA, AMCA can predict increased disease severity and complications of CD (strictures or fistulas) as well as the need for possible surgery.
- Correlation with CD genes
Several studies correlate ALCA, ACCA and AMCA with mutations and genetic variants in innate immunity and defense in system genes associated with CD, demonstrating the importance of serological markers and the path physiology of IBD
- Using the IBDX panel
IBD does not have a consistent appearance. It varies according to locations, behaviors, severities and activities. Considered a multifactor disease, as a result IBD requires a combination of serological markers (panel) for complete diagnosis.
Results are reported for each of the markers alone and also depends on the number of sera positives each patient have.
- Quick and Easy to Use
All kits have short incubation times and ready-to-use reagents.
- Break-a-Well Format
Glycominds' IBDX kits have break-a-well strips allowing high flexibility and economic use.
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