What is PD CEN/TS 17305- Specifications for pre-examination processes for saliva about?
PD CEN/TS 17305 is a standard on Molecular in vitro diagnostic examinations that outline specifications for pre-examination processes for saliva for Isolated human DNA.
PD CEN/TS 17305 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.
PD CEN/TS 17305 applies to molecular in vitro diagnostic examination including laboratory
developed tests performed by medical laboratories.
Note 1: Dedicated measures that need to be taken for saliva collected on absorbing material or by mouthwashes are not described in PD CEN/TS 17305. Neither are measures for preserving and handling native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
Note 2: International, national, or regional regulations or requirements can also apply to specific topics covered in PD CEN/TS 17305.
Who is PD CEN/TS 17305 - Specifications for pre-examination processes for saliva for?
PD CEN/TS 17305 on the specifications for pre-examination processes for saliva is relevant to:
- Diagnostics developers
- Medical laboratory
- manufacturers of biomedical
- Biobanks
- Institutions and commercial organizations performing biomedical research
- Medical regulatory authorities
Why should you use PD CEN/TS 17305 - Specifications for pre-examination processes for saliva?
Molecular in vitro diagnostics has enabled significant progress in medicine. Genetic examination of DNA is commonly used in clinical practice. This includes e.g. predisposition
testing, pharmacogenomics, analysis of genetic disorders with the perspective of use in precision medicine. Saliva is increasingly used as a non-invasive alternative specimen to blood for the examination of human DNA. Saliva naturally contains microorganisms and also extraneous substances (e.g., food debris), which make the composition of saliva more complex and unique among patients/donors.
Dedicated measures are therefore needed for informing and preparing patients/donors for the collection and to check compliance with the instructions, to reduce the specimen variability.
PD CEN/TS 17305 provides special measures which need to be taken to obtain good quality saliva specimen/samples and isolated DNA therefrom for human DNA examination.
PD CEN/TS 17305 assists by guiding medical laboratories/ in vitro manufacturers to be aware of specimen variability when performing design verification and validation.