Immunoassay-based Single and Multiplex Biomarker Assays (ELISA, MSD, Luminex)
MicroConstants provides testing and analysis services to support preclinical and clinical diagnostic research of new therapeutics. We perform biomarker assay development, validation, and profiling of disease panels using using single and multiplex LC/MS/MS, MSD, ELISA, Luminex, and enzyme activity techniques.
Single and multiplex immunoassay kits using ELISA, EIA, Luminex and MSD for biomarker analyses remain a mainstay for the drug development process, although such kits can vary dramatically in terms of sensitivity, specificity, availability, quality, among other factors. MicroConstants has many years of experience with selection of the optimal biomarker immunoassay kit. If the required kit is not available, or the choices not suitable, we can create the assay de novo to meet demanding specifications. The multiplex technologies available at MicroConstants (Luminex, MSD) enable us to simultaneously analyze for up to 100 analytes in each sample. Nucleic acids or protein samples are examined to detect biomarkers that correlate with the progression of a disease or success of a therapy.
Performing multiplex biomarker analysis using the Luminex platform with xMAP technology, or MSD with their V-PLEX validated assay kits, enables us to:
- Profile disease panels with fast reaction kinetics
- Develop assays with a wide dynamic range and high reproducibility, specificity, and sensitivity
- Require smaller sample sizes than single-plex biomarker assays
- Generate more information on interrelationships between analytes within a single sample
- Provide the high-throughput and high-content data required for simultaneous multiple lines of investigation of complex diseases and of combinatorial correlations of coexistent pathologies
LC/MS/MS Biomarker Assays
MicroConstants develops and validates highly selective bioanalytical methods for the simultaneous quantitation of multiple biomarker peptides or epitope peptides of monoclonal antibodies in serum or plasma matrices using Solid Phase Extraction (SPE) coupled with UPLC/MS/MS. The increased sensitivity of the Xevo TQ-S triple quadrupole mass spectrometer coupled with UPLC provides the specificity, accuracy and precision required for biomarker quantitation.
Immunological Biomarker Assays
Many biomarkers remain esoteric and are not offered as kits, or the kits available have unfavorable performance characteristics. In such situations, MicroConstants provides assay development services using critical reagents (e.g., capture/detection antibodies, recombinant or natural biomarker reference materials) obtained from the client, commercial vendors or, in the case of antibodies, made to order. Such assays can undergo either full (i.e., GLP quality) validation or the less rigorous process of qualification (i.e., fit-for-purpose) at the discretion of the client. Possible analytical platforms include MSD, ELISA, EIA, and bead (Luminex) technologies in the following formats:
- Competitive immunoassays for peptides and small molecules such as nucleotides and eicosanoids
- Immunometric or “sandwich” formats for large protein analytes including therapeutic antibodies, cytokines, cell stress proteins, and signaling pathway regulators
Each assay undergoes rigorous testing to ensure high precision and accuracy while also delivering the sensitivity and specificity required to detect biological levels of analytes in over 35 biological matrices including blood, serum, plasma, CSF, and tears. High-throughput screening using automated instrumentation is also available.