ISO standards for histological examination

Melanoma diagnosis, after dermoscopy, is usually confirmed by histological examination on formalin-fixed and paraffin-embedded (FFPE) tissues.

FFPE tissues represent also the source of nucleic acids, especially DNA, for further molecular analyses, included BRAF and NRAS mutations detection. FFPE tissues are submitted to certain pre-analytical processes that alter partially the biomolecules, included nucleic acids. Therefore, the standardization of pre-analytical processes is pivotal both in diagnostic and biomedical research in order to obtain reliable and reproducible results.

Thanks to iToBoS project, in a recent study [1], published by the group from the University of Trieste, the need to follow strictly ISO standards [2-4] for in vitro diagnostics is stressed in order to have reliable molecular analyses in FFPE tissues.

Serena Bonin, University of Trieste.

References:

1. De Martino E, Medeot C, D’Amico L, Stanta G, Bonin S: Impact of standardization in tissue processing: the performance of different fixatives. New Biotechnology 2022, 71:30-36.
2. ISO 20166-1:2018 I: Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA. In.; 2018.
3. ISO 20166-2:2018 I: Molecular in vitro diagnostic examinations -- Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 2: Isolated proteins. In.; 2018.
4. ISO 20166-3:2018 I: Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA. In.; 2018.