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Clinical biospecimens: reference materials, certified for nominal properties?

This report makes the case for clinical biospecimens to be certified for nominal properties, in particular the diagnosis, and to attain the level of Reference Materials. Clinical certified biospecimens that are collected, processed, characterized, stored, and distributed by biobanks are urgently needed to facilitate diagnostic test development, evaluation, and quality assurance. Four examples are provided to illustrate this purpose and the certification approaches that could be applied are proposed.