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ELISA Development Services

GenWay’s experience in development of proteins and antibodies allows for rapid, high quality development and validation of ELISA assays. We routinely develop and utilize assays for specific analysis needs. Based upon our capability and core competency in proteins and antibodies, we can providing first-in-class assay development and standardization for our clients.


  1. Collect and test matching antibodies, reagents, and control samples
  2. Optimize assay conditions for kit components and samples
  3. Determine incubation times and temperatures
  4. Establish acceptance criteria
  5. Perform sensitivity and precision analysis
  6. Specify upper and lower limits of detection and quantitation
  7. Control lot to lot consistency


  1. Draft validation protocol and document sample requirements
  2. Perform validation testing and report validation results
  3. Comply with ISO/GMP/CLIA requirements as defined by customer
  4. Comply with customer supplier qualification requirements

Quality Management System

  1. Quality Policy Manual - Quality System Procedures, Control of Documents, Control of Quality Records
  2. Product Realization – Planning, determination of requirements
  3. Production – Control, validation of processes, traceability, product preservation

Contact us and receive a quote within 24 hours
  • Email: sales@genwaybio.com
  • Phone: 858.458.0866
  • ELISA Validation Services GenWay offers a full line of custom ELISA Assay services including Assay Development, Assay Validation, Clinical Trial Testing, and Clinical (CLIA) Testing. We leverage our expertise in development and validation of antibodies and antigens to reduce development time and improve assay results. Our ELISA Validation services include:
    1. Draft a Validation Protocol with input from the customer’s QA and Regulatory personnel.
    2. Document all sample requirements including blinding, procurement, accessioning, testing, storage, and retention.
    3. Perform Validation testing, according to the Validation Protocol
    4. Report the Validation Results and provide a Summary Report including data analysis
    5. Comply with ISO/GMP requirements, as defined by the customer
    6. Comply with customer supplier qualification requirements, such as supplier audit, as defined by the customer.
    Contact us to learn how we can support your ELISA development needs or fill out the custom quotation form above.