Reference project

Method development for laboratory diagnostics

A client wants to develop a new diagnostical procedure using biological markers. Biomarkers in point-of-care devices using standardized reaction sequences are verified with a specific method.


We offer the highest quality and a reliable service to the manufacturers of diagnostic devices – so that diseases can be recognized at an early stage a nd treated correctly.

Tatjana Burchart, Unit Leader, Laboratory Analysis and Methods Validation, EXCO GmbH

Activities & Realization

The client contracts EXCO for collaboration in the development of the test strip and the biochemical measuring procedures.

  • Development of biochemical measuring procedures particularly regarding the sensitization and minimising of interferences:
    proactively based on literary research and further development of standards.
  • Immunoassay development for use in patient-side laboratory diagnostics. Configuration of the assay for the detection of the Antigen.
  • Assessment of input materials regarding purity, impurities, Enzyme activity and completion of the requested analytical measurements according to the specified work instructions and documentation of the results.
  • Development and configuration of a test strip in the sample production.
  • Completion of functional tests with assembled test strips.

Client benefits
  • The client gets reliable information about the suitability of the newly developed measuring processes.
  • Shorter development times.

Client

Manufacturer of medical devices and diagnostic equipment, Germany

Expert contact

Tatjana Burchart

T+49 6233 73778-140