Molecular in vitro diagnostic examinations - Specifications for preexamination processes for saliva - Isolated DNA

General information

30.98 Project deleted   Feb 22, 2017


CEN/TC 140 In vitro diagnostic medical devices

Technical Specification


This Technical Specification recommends the handling, documentation, storage and processing of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities.
A standardization of the entire process from specimen collection to the DNA examination is needed due to DNA degradation and fragmentation after saliva collection. Therefore, special measures need to be taken to secure good quality saliva samples for (genomic) DNA examination. This is particularly relevant for analytical test procedures requiring high molecular weight DNA.
Studies have been undertaken to determine the important influencing factors. This International Standard draws upon such work to codify and standardize the steps for saliva DNA examination in what is referred to as the pre-examination phase.
Pathogen DNA present in saliva is not covered by this Technical Specification.
Cell-free saliva DNA is not covered by this Technical Specification.
NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this Technical Specification.

Life cycle


30.98 Project deleted
Feb 22, 2017