is the first in vitro multiplex allergy test allowing simultaneous measurement of total IgE (tIgE) and specific IgE (sIgE) against a plethora of allergen extracts and molecular allergens.
Based on our test panels composition of allergen extracts and molecular allergens, a near complete picture of each patient’s sensitization status is obtained. ALEX is based on our proprietary nano-bead technology. Every allergen (extract) can be individually optimized for production. The flexible analysis software, allows our customers to analyze tailormade allergen panels as they see fit for their clinical needs – Multiplex on demand.
The ALEX assay protocol integrates a powerful Cross-reactive Carbohydrate Deteminants (CCDs) inhibitor during serum incubation, which will clear up your specific IgE results. This reduces the interpretative burden for physicians of CCD positive patients and increases the specificity of our test results.
ALEX is the next generation in vitro test for type I allergies. With an allergen panel of more than 280 allergen extracts and molecular allergens complemented by total IgE, we aim at above 99 % coverage of all routine diagnostic needs.
Our patent-pending technology was designed for testing hundreds of allergens in parallel without accepting a compromise on the performance of any single parameter.
The ALEX assay protocol integrates a powerful Cross-reactive Carbohydrate Determinants (CCDs) inhibitor during serum incubation, which will clear up your specific IgE results. This reduces the interpretative burden for physicians of CCD positive patients and increases the specificity of our test results.
The quantification is based on a colorimetric image acquisition, using CMOS sensors and instrumentation.
|Detection method||Colourimetric enyzme assay|
|Assay time||3.5 hours|
|Tests per run||Up to 50 per operator, manual processing|
|Measuring range sIgE||0.3–50 kUA/L, quantitative|
|Measuring range tIgE||1–2500 kU/L, semi-quantitative|
|Precision/CV % total||< 15 %|
|Precision/CV % intra assay||< 10 %|
|Sample requirements||100 microliter serum or plasma (except EDTA)|
|Interference||No significant interference from high total IgE, hemoglobin, bilirubin or triglycerides, see instructions for use for details|
|Calibration method||Integrated, batch and allergen correction factors encoded by integrated 2D barcode|
All necessary lab equipment for processing & analysis of ALEX will be provided by Macro Array Diagnostic
Lab Rocker & Incubation Chamber4
Raptor Analysis Software5
Windows PC/Laptop (only provided on request)6
While some imaging or scanning devices are expensive, delicate and bulky, MADx’s ImageXplorer is an easy-to-use and affordable device requiring only 15x18x18 cm of your preciouslab space. Both connection and power supply are managed through your personal computers USB port. The acquisition and analysis of a single test takes only seconds.
Conventional single-plex test systems can be laborious in obtaining comprehensive sensitization profiles. Often, several testing cycles are required to come to a clear diagnosis, and total IgE has to be tested separately.
To streamline this fragmented approach, ALEX gives you a near complete picture of your patient’s situation including total IgE.
More than 150 allergen extracts and more than 100 molecular allergens are at your disposal. Exclusively available molecular allergens include risk markers from storage protein families and other new markers (e.g. house dust mite, malassezia sympodialis.
Specifically designed for ALEX, the Raptor analysis software offers maximum flexibility. Choose between up to 20 predefined symptomatic or allergen source based panels (like pollen, anaphylaxis, nuts, insects, etc.)
Lab measurement results will only be displayed and reported for the selected allergens. Alternatively, define your own custom allergen panels to match your personal and your patients needs. This allows you to account for regional differences in allergen exposure and avoids unnecessary testing.
Approximately 25 % of patients have anti-CCD IgEs, resulting in a significant number of positive sIgE results, especially when testing allergen extracts. Anti-CCD antibodies have been reported to be clinically insignificant (Malandain H et al. 2007; Eur Ann Allergy Clin Immunol).