Creative Biolabs offers custom assay development services that bridge the path from discovery to product. Our scientific expertise provides highly custom solutions for unique in vitro diagnostics (IVD) assays to meet our clients' basic, applied and clinical research demands. It is applied to all assay development at Creative Biolabs, and it is the key to accelerating your innovation in IVD research.

Assay Development

The first step in developing a diagnostic assay is demonstrating the feasibility or the ability to detect the analyte under optimized conditions. Next, the process of evaluation usually consists of determining analytical metrics, including analytical sensitivity, analytical selectivity, limit of detection (LoD), trueness and precision. These analytical statistics provide an abundance of information about the assay including the quantitative change in response for varying analyte amounts, the reportable range and linear response of the assay, the smallest analyte amount, how interferents affect the response, and the trueness and precision of the assay.

Custom Assay Development Services

Custom Assay Development Services at Creative Biolabs

With years of experience in IVD assay development, Creative Biolabs has a full spectrum of capabilities for a wide range of IVD assay development, including enzyme-linked immunosorbent assay (ELISA)-based assay, radioImmunoAssay (RIA)-based assay, lateral-flow immunochromatographic assay (LFIA)-based assay, latex particle-enhanced turbidimetric immunoassay (LETIA)-based assay, western blot (WB)-based assay, immunohistochemistry (IHC)-based assay, and flow cytometry (FC)-based assay. We have the expertise to design, develop and execute the necessary assays at all phases of the project. Our development process is the fastest, high-efficient and most streamlined system to get our clients' IVD assay project through our proven quality control system, manufactured, approved and to market. Our seasoned scientists can direct and manage all aspects of the assay efforts and the resulting data that is generated. By applying our staff's experience and a proven quality system, we are confident to complete your IVD assay development project with speed, accuracy and the quality necessary for FDA and other international regulatory agency approvals.

Custom Assay Development Services

Highlights

  • In-depth knowledge in IVD assay development
  • A full spectrum of capabilities
  • Powered by a proven, first-in-class technology
  • High flexibility and cost-effectiveness
  • Reliability and information security

Scientists at Creative Biolabs are experts in IVD assay development. If you don't find the assay you want, bring your custom projects to us. Every assay development will require a custom design. We consult with you from start to finish to meet your unique needs. Please contact us to discuss your assay development needs and a detailed quote.

References

  1. Jacobson, R.H. et al. Principles of validation of diagnostic assays for infectious diseases. 1998.
  2. Borysiak, M.D.; et al. Translating diagnostic assays from the laboratory to the clinic: analytical and clinical metrics for device development and evaluation. Lab on a chip. 2016, 16(8):1293-313.

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