ELISA (Enzyme-Linked Immunosorbent Assay)

CMDC Labs biotechnology testing laboratory offers ELISA as a highly quantitative, specific and sensitive immunoassay method for detecting and quantifying antibodies or antigens, cytokines, hormones, proteins or protein motifs, protein secreting single cells and other biologic drugs as well as DNA for which there is a specific antibody. Sensitivities for the ELISA can be in the pg/mL range. The CMDC Labs scientists have developed direct, indirect, sandwich and competitive ELISAs in which the target analyte is specifically detected in a complex matrix, such as whole blood, plasma, serum, urine from humans or various species or in cell lysate and cell culture media.

Applications of ELISA

CMDC Labs biotechnology testing laboratory clients have successfully developed and completed ELISA service work for the following common examples:

  • Immunotoxicity of medical device materials
  • Biological response of proteins, primary cells and stem cells to medical device materials
  • Small molecule and biologics release/quantitation and development
  • Foodborne pathogen and allergen detection
  • Diagnosis of infectious disease and cancer


The ELISA is a highly quantitative, sensitive and selective bioassay that is the benchmark for high-throughput and multiplexed detection and quantification of various soluble substances including antibodies/antigens, cytokines, hormones, proteins, oligopeptides, biotoxins, etc. Designed to process a large number of samples in a multi-well format, singleplexed and multiplexed ELISAs can be used to evaluate numerous target molecules in a single run. This bio-detection technique is often used in the medical device industry as well as in the fields of medicine, biological study, diagnostics, agriculture and food science due to its exquisite simplicity, sensitivity and highly specific receptor-target ligand coupling characteristics.

CMDC Labs’ Experience with ELISA

CMDC Labs scientists have significant experience with direct, indirect, sandwich or competitive ELISA assays. Additionally, we have developed highly specific cell-ELISAs using adherent cells or membranes to characterize target ligands (e.g., antibodies) against surface markers (e.g., antigens) expressed on cell surfaces. Our experience includes bioanalysis of not only small molecular targets (e.g., amino acids, neurotransmitters, biotoxins) but also large molecules (e.g., proteins, biologics) in complicated matrices using various ELISA formats. Most clients request direct or competition ELISAs with colorimetric, fluorescent, luminescent and time-resolved readouts. We have the ability to process high-throughput ELISAs and multiplexed ELISA bioassays for multiple analytes in a single sample, saving time and cost.

ELISA has been a workhorse tool at CMDC Labs for the past 20 years due to its high throughput, selectivity and sensitivity. CMDC Labs scientists have deep experience with ready-made and custom-designed ELISA assays in addition to method qualification and validation.

Planning for Projects with Long-Term ELISA Needs

CMDC Labs professionals are biotechnology scientists and regulatory professionals engaged in the industries of medical device, pharmaceutical, diagnostics, agriculture and food, providing contract research for clients. Pre-clinical or clinical data generated from each experiment is reported concurrently with all methods, materials, and data (both raw and analyzed). CMDC Labs’ previous collaborations and track record of producing high-quality data for client project scientists and program managers is an important consideration for maximizing the probability of success in new client projects.

Contact us today for expedited timelines, reduced costs and expert support from research to rollout.