Christian Harwanegg, CEO at MacroArray Diagnostics GmbH, states: “We are happy to announce that the Allergy Explorer test kit called ALEX is now CE marked and available as an IVD product. ALEX is the first in vitro multiplex allergy test allowing simultaneous measurement of total IgE and specific IgE against a plethora of allergen extracts and molecular allergens.” Based on Macro Array Diagnositcs’ 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 a proprietary nano-bead technology. Every allergen (extract) can be individually optimized for production. The flexible analysis software, allows customers to analyze tailor-made allergen panels as they see fit for their clinical needs.
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. ALEX streamlines this fragmented approach. More than 160 allergen extracts and 122 molecular allergens are provided. Exclusively available molecular allergens include risk markers from storage protein families and other new markers. For a full allergen list please see the list provided here:https://www.dropbox.com/s/047gaqb29iri8au/ALEX%20Allergen%20list%20EN.pdf?dl=0
About the technological background
The core technology is based on a two-phased manufacturing process. While other multi-parameter ELISA assays use identical settings for the immobilization of all antigens, Maro Array Diagnostics is able to adjust these conditions for each antigen individually, until the optimal result is obtained.
In the first step, antigens are coupled to activated nano-particles. This allows for individual and combinatorial optimization of each antigen coupling process. Each antigen is attached reflecting its biochemical properties and specific requirements for stability, which preserves the full epitope complexity of the source preparation. The nanoparticles multiply the surface of the solid phase presenting the antigen during the immunoassay, thereby enabling highly sensitive detection.
In the second step, the antigen-bearing nanoparticles are deposited contact free onto a solid phase matrix, forming a macroscopic array of individual assay parameters.
While requiring barely more serum than a miniaturized microarray test, the analytic performance can be greatly increased in terms of assay sensitivity and total precision.
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.
The quantification is based on colorimetric or luminescence image acquisition, using CMOS sensors and instrumentation significantly cheaper than confocal laser scanners.
About Macro Array Diagnostics GmbH
acro Array Diagnostics is a Vienna-based MedTech company, and was founded in 2016. We develop, produce and distribute tests, instruments and software for allergy diagnostics and research applications. Our products allow flexible, reliable and affordable sensitization profiling of each patient. Our multidisciplinary team ensures that customers receive the most advanced tools to fulfill their diagnostic needs.
MacroArray Diagnostics GmbH
Gutheil Schoder Gasse 17
Dr. Christian Harwanegg
Tel.: +43 1 865 25 73