ISO/PWI TS 18701

Molecular in vitro diagnostic examinations — Specificationsfor pre-examination processes for human specimens — Isolated microbiome DNA

Scope

This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.

This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimens, 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 pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.

Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in ISO 4307, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.