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The Diagnostics Development Laboratory (DDL) was set up in 2012 in the framework of an EFRE-founded public private partnership. Due to the increasing demand for highly sensitive and specific diagnostic methods, we devote ourselves to developing serological assays for the reliable diagnosis of tropical and emerging diseases.
With the DIN EN ISO 13485 compliant quality management system implemented, the assay development process comprises the following steps:
· Identification of antigens
· Expression and purification of antigens
· Assay principle approval and assay optimization
· Assay verification and validation
· Production and quality control of assay components
To ensure a reliable sample supply for assay verification and validation, a reference sample bank organizing the collection, documentation and archiving of patient samples was established.