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Assay Development

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Calbiotech assay development services are backed by over 25 years of expertise and 150 different Immunoassay kits that have been developed, manufactured and distributed to over 40 countries across the globe. Examples of Custom Development services include:

  • ELISA or Chemiluminescent ELISA assay kits or components for human or animal matrices. 
  • Custom developed assays for further manufacturing or technology transfer.
  • Design Control suitable for RUO or FDA PMA/510(k) submission.
  • Fast turnaround time and competitive pricing.

The R&D Team at Calbiotech is highly skilled in assay development, specifically ELISAs and Chemiluminescent ELISAs. Using novel techniques and formulations, they are often able to overcome obstacles in development and build robust, reproducible assays for our clients.

Validation Studies

During assay development, we work hand in hand with you and your team to ensure project goals and timelines are being met. Using validated design control methods, we provide the following deliverables throughout the development phase:

  • Analytical Sensitivity Study
  • LOQ/LOD Analysis
  • Cross reactivity with relevant targets report
  • Specificity with other targets report
  • Intra and Inter-assay precision Studies
  • Linearity Study
  • Parallelism Study
  • Normal range and diseased sample ranges analysis

Timeline & Costs

A standard ELISA assay development timeline, assuming key raw materials are provided by the client, can typically be completed in 6-8 weeks. Costs associated with a similar development scenario start at $7500. Please contact us for a more detailed estimate for your project.

We know that selecting a development partner requires evaluating an organization's capacity, development capability and flexibility, available technology, technical expertise, and customer service orientation. Please complete the form below or contact us directly to discuss your assay development needs.

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