What is ISO 4307 about?
ISO 4307 addresses Molecular in vitro diagnostic examinations and specifies requirements and recommendations on the handling, storage, processing, and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouthwashes are not described in ISO 4307. Neither are measures for preserving and handling native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE: International, national, or regional regulations or requirements can also apply to specific topics covered in ISO 4307.
Who is ISO 4307 for?
ISO 4307 on molecular in vitro diagnostic examinations is useful for:
- Medical laboratories
- In vitro diagnostics developers, manufacturers, biobanks, institutions.
- commercial organizations performing biomedical research, and regulatory authorities.
Why should you use ISO 4307?
Molecular in vitro diagnostics has enabled significant progress in medicine. Standardization of the entire process from specimen collection to DNA examination is needed to minimize pre-examination impacts such as DNA degradation and fragmentation after saliva collection.
Using ISO 4307 guidelines, you will be able to take special measures and obtain good quality specimens and isolated DNA therefrom for human DNA examination.