ELISA Development

ELISA Assay ImageELISA, or Enzyme Linked Immunosorbent Assay, is a practical option for a sensitive and simple assay for use in research and clinical diagnostics. Applications are diverse, and include medical diagnostics, vaccine formulation/QC, biotherapeutic formulation testing, biotherapeutic biodistribution testing and many others. ELISA’s come in multiple formats including direct ELISA where an antibody is conjugated to an enzyme such as horse-radish peroxidase, indirect ELISA where an enzyme conjugated secondarily antibody or labelled streptavidin is used, and competitive ELISA’s where the antigen itself is labelled.

The Pegasus team has over 60 years of ELISA development experience. All assay development projects are tailored to fit the customer’s specific needs and regulatory requirements. The services provided include but are not limited to antibody generation, ELISA development, and validation. All of our R&D work is performed under our robust QMS system.

ELISA assay development includes:

  1. Antibody pair identification
    Target capture and identification antibodies are selected and optimized based on high affinity and sensitivity determined from signal-to-noise ratio titration.
  2. Assay optimization
    Experimental determination of optimal sample and antibody concentrations for acceptable signal generation and detection where our process involves applying DOE (Design of Experiments) methodology to address and eliminate effects such as non-specific binding or interference. We develop precise standards and generate a standard curve that best reflects the characteristics of the sample. Our protocol designs are specific to the target of interest and reflect the optimal range of sensitivity.
  3. Assay validation
    Pegasus will validate assays to establish robustness, precision, and specificity, while assessing assay performance by looking at factors such as sample stability, limit of detection, dilutional linearity, Spike-in and recovery and selectivity. Assay components and incubation steps are also optimized to meet the detection requirements of the assay.

For more information on our ELISA development services, call us at (855) 498-3398, or send us your information using our contact form.

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