This document gives requirements 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.
This document is applicable to molecular in vitro diagnostic examination including laboratory
developed tests performed by medical laboratories. It is also intended to be used by laboratory
customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial
organisations performing biomedical research, and regulatory authorities.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth
washes are not described in this technical specification. Neither are measures for preserving and
handling of 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 this document.