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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

ISO 4307:2021

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

This document specifies requirements and recommendations 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 can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations 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 document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.

This document is available in electronic format only.

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Details

Date of Publication: October 1, 2021

Order Code PDF: ISO4307E

Order Code Print: print not available

Edition: First

Pages: 12

ISO 4307:2021 Additional Details

Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.