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Aeirtec generates custom multiplex assays (internal validated kits) constructed from commercially available components certified for the purpose. Were projects require, Aeirtec will use commercially available multiplex assay kits with predefined marker panels that Aeirtec independently validates before application. Use of Aeirtec's internally generated kits assists in utilisation of Aeirtec's high sensitivity technology.
Aeirtec either constructs a multiplex assay kit according to a project protocol listing of required markers or will advise on the markers for inclusion; often designing the entire panel. By way of example, the following link illustrates a 43 marker atopic immune panel incorporating cytokines, chemokines, soluble receptors and growth factors that was designed and constructed by Aeirtec for use in clinical studies of allergy.
Aeirtec have generated a multiplexing facility, compliant under GLP and ISO 17025, with independent quality assurance. Therefore all activities including multiplex assay panel construction are conducted under an infrastructure of standard operating procedures (SOPs). In parallel, Aeirtec are applying their expertise in development of a new multiplexing platform design and are therefore familiar with GMP requirements.
Within establishment of a custom generated multiplex panel is a routine validation procedure (SOP) to examine aspects of assay specificity, detection antibody to capture antibody cross reactivity, and measurement precision and accuracy. This involves generation of values for recovery, intra- and interassay variability, lower limit of detection (LOD), lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ); LLOQ and ULOQ providing the dynamic range.
Multiplex Assay Design and Generation
Flexibility of Assay Origin