Central Laboratory Biomarker Service

The Luminex assay platform requires only a low volume sample (generally <200μL) for testing and is this volume is typically sufficient to quantify the levels of 10-30 analytes simultaneously. The Luminex assay platform incorporates an array of analyte specific beads, each being a 'miniaturised ELISA immunoassay platform' for multiple simultaneous ELISA assays in the same measurement chamber; allowing the concentration of many analytes to be measured in a single low volume sample.

Another advantage of the Luminex technology is the multiple commercially available bead arrays to simultaneously quantify the concentration of a vast range of commonly measured cytokines, growth factors and enzymes e.g. tumor necrosis factor α (TNFα), interleukin-1 (IL-1), interferon-γ (IFNγ) granulocyte macrophage colony stimulating factor (GM-CSF), monocyte chemotactic peptide 1 (MCP-1), vascular endothelial growth factor (VEGF), matrix metalloproteinase 3 (MMP3). The versatility and scope of analyte concentration-testing is further expanded by the ability to generate and customise bead arrays.

Key advantages:

• Simultaneous quantification of multiple analyte levels
• Low demand for sample volume (generally <200μL)
• Faster and more economical data acquisition
• Multiple commercially available kits allowing measurement of release products from all groups of cell types including: lymphocyte, monocyte, macrophage, granulocyte, tumor cells, mesenchymal cells.
• Ability to customise and generate kits in house for optimised measurement of study and clinically relevant groups of analytes including: cytokines, chemokines, growth factors, and enzymes.

Benefits and Quality of our Service

Aeirtec's development studies have demonstrated the direct beneficial combined effect of (1) the proprietary methodology for serum or plasma multiplex-ELISA assay outlier detection and (2) multiple sample replicates that Aeirtec uses, on clinical study power for efficacy detection and the number of subjects required; directly impacting on the success, time and cost of a clinical study (figure 1).

Independent studies have demonstrated the problems that other central laboratories can encounter when measuring samples without validated outlier detection and produce when measuring samples in single replicate; where outliers cannot be detected (Djoba Siawaya JF, et al. (2008) An Evaluation of Commercial Fluorescent Bead-Based Luminex Cytokine Assays. PLoS ONE 3(7): e2535.)

Aeirtec conducts studies according to GLP, unless clients request non-GLP compliance to reduce costs.

Aeirtec's central laboratory conducts bodily fluid biomarker measurement in the following range of diseases: oncology including, solid tumor (e.g. lung cancer and breast cancer) and leukemia, autoimmune (e.g. rheumatoid arthritis), and inflammatory disease (osteoarthritis), immune disorders, respiratory (COPD), musculoskeletal, allergy, rhinitis and asthma, gastrointestinal (inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS)), cardiovascular, metabolic and endocrine (diabetes), central nervous system (CNS) and dermatology (eczema, psoriasis).

To discuss your requirements, email: info@aeirtec.co.uk




				Aeirtec's accuracy and precision in measurement are optimized for greater study power and efficacy significance. Aeirtec's group have been involved in clinical trial design, conduct and analysis for over 2 decades. With this level of clinical study insight, we therefore recognize the critical need for maintenance of study power and significance of efficacy. These are the primary reasons that have driven Aeirtec to achieve optimization of accuracy and precision in our multiplex marker assay measurements. Detection of clinical trial efficacy significance with reduced patient requirements. Aeirtec's central laboratory standard operating procedures (SOPs) for multiplex-ELISA serum or plasma sample biomarker measurement (immune-inflammatory mediators, cytokines, growth factors, enzymes) have demonstrated enhanced clinical trial powering for efficacy detection and lower patient number requirements (Figure 1); reflected in independent studies (1). This is achieved through our proprietary methodology for outlier detection and elimination, and greater assay replication. Multiple Biomarker Strategy Aeirtec's 20 years parallel experience in clinical trial conduct, analysis and clinical trial design service provides further disease insight for optimization of blood, serum, plasma and sputum multiple biomarker strategy and choice for multiplex ELISA assay. Aeirtec's central laboratory is integrated immune-inflammatory pharmacology service laboratories, which also provide flow cytometry of blood samples from clinical studies to assess cell activation status. Aeirtec has also conducted a formal study to optimize the ex-vivo testing of efficacy against inflammatory stimuli (e.g. LPS) of whole blood cell activation through multiplex-ELISA immunoassay of cell release products (e.g. plasma immune-inflammatory mediators, cytokines, chemokines, growth factors, enzymes). To discuss your requirements, email: info@aeirtec.co.uk Multiplex Assay: Simultaneous testing of analyte levels in a low volume sample Aeirtec employs Luminex®-based multiplex technology to simultaneously quantify the concentration of multiple analytes. (Luminex® is a registered trademark of Luminex Corporation). We have found this bead-based system preferable to planar array systems, because of (1) the far greater number of analytes than can be measured, (2) the much larger number of commercial kits that can be used and (3) the capacity to customise the choice of analytes to quantify within a study's samples (recently reviewed: Qin Fu, et al., (2010) Comparison of Multiplex Immunoassay Platforms Clin Chem.; 56(2): 314–318).
The Luminex assay platform requires only a low volume sample (generally <200μL) for testing and is this volume is typically sufficient to quantify the levels of 10-30 analytes simultaneously. The Luminex assay platform incorporates an array of analyte specific beads, each being a 'miniaturised ELISA immunoassay platform' for multiple simultaneous ELISA assays in the same measurement chamber; allowing the concentration of many analytes to be measured in a single low volume sample. Another advantage of the Luminex technology is the multiple commercially available bead arrays to simultaneously quantify the concentration of a vast range of commonly measured cytokines, growth factors and enzymes e.g. tumor necrosis factor α (TNFα), interleukin-1 (IL-1), interferon-γ (IFNγ) granulocyte macrophage colony stimulating factor (GM-CSF), monocyte chemotactic peptide 1 (MCP-1), vascular endothelial growth factor (VEGF), matrix metalloproteinase 3 (MMP3). The versatility and scope of analyte concentration-testing is further expanded by the ability to generate and customise bead arrays. Key advantages: • Simultaneous quantification of multiple analyte levels • Low demand for sample volume (generally <200μL) • Faster and more economical data acquisition • Multiple commercially available kits allowing measurement of release products from all groups of cell types including: lymphocyte, monocyte, macrophage, granulocyte, tumor cells, mesenchymal cells. • Ability to customise and generate kits in house for optimised measurement of study and clinically relevant groups of analytes including: cytokines, chemokines, growth factors, and enzymes. Benefits and Quality of our Service Aeirtec's development studies have demonstrated the direct beneficial combined effect of (1) the proprietary methodology for serum or plasma multiplex-ELISA assay outlier detection and (2) multiple sample replicates that Aeirtec uses, on clinical study power for efficacy detection and the number of subjects required; directly impacting on the success, time and cost of a clinical study (figure 1). Independent studies have demonstrated the problems that other central laboratories can encounter when measuring samples without validated outlier detection and produce when measuring samples in single replicate; where outliers cannot be detected (Djoba Siawaya JF, et al. (2008) An Evaluation of Commercial Fluorescent Bead-Based Luminex Cytokine Assays. PLoS ONE 3(7): e2535.) Aeirtec conducts studies according to GLP, unless clients request non-GLP compliance to reduce costs. Aeirtec's central laboratory conducts bodily fluid biomarker measurement in the following range of diseases: oncology including, solid tumor (e.g. lung cancer and breast cancer) and leukemia, autoimmune (e.g. rheumatoid arthritis), and inflammatory disease (osteoarthritis), immune disorders, respiratory (COPD), musculoskeletal, allergy, rhinitis and asthma, gastrointestinal (inflammatory bowel disease (IBD), inflammatory bowel syndrome (IBS)), cardiovascular, metabolic and endocrine (diabetes), central nervous system (CNS) and dermatology (eczema, psoriasis). To discuss your requirements, email: info@aeirtec.co.uk