scope:

This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for the pre-examination phase for infectious disease examination (eg. targeted pathogen identification). These are not described in this document. Different dedicated measures are taken for the pre-examination phase of saliva for human genomic DNA examination. These are not described in this document but are covered in CEN WI00140116, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA. NOTE - International, national or regional regulations or requirements can also apply to specific topics covered in this document.