Development and validation of assay systems

ImmBioMed is specialized in developing immunological and molecular biological assays for testing of human sample material.

In the recent years, ImmBioMed has developed over 50 assay systems for testing of diverse parameters in human sample material. This included classical Enzyme-Linked Immunosorbent Assays (ELISA) and Immuno-Blot assays, as well as qualitative and quantitative molecular biologial, i.e. PCR-based protocols, with a special emphasis on real-time PCR.

Specific details on these development projects are available upon request. To request more information, please contact us by clicking here.

Development of assay systems for human samples requires validation. The validation process addresses issues, like specificity, sensitivity, matrix interference, limit of detection, stability, clinical accuracy etc. Guidelines are available to structure the validation process.

For development and validation certain DIN/ISO documents apply, such EN ISO/IEC 17025. In addition, comprehensive information is available through guidelines published by scientific organisations, like Eurachem and the Clinical and Laboratory Standards Institute.

For quantitative real-time PCR, the so-called “MIQE guidelines” are pertinent. “MIQE” stands for “Minimum Information for Publication of Quantitative Real Time PCR Experiments”. Mutatis mutandis, the basic principles given in this guideline also apply to qualitative real-time PCR protocols. The letter may be used e.g. for allele-specific detection methods, to routinely assess genetic heterogeneity.

Based on the guiding information, ImmBioMed supports potential customers in defining the extent and scope of the validation process for a given project. Clinical validation includes the application for a vote by the local ethics committee.