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BS EN ISO 4307:2021

BS EN ISO 4307:2021

$102.76

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

Published By Publication Date Number of Pages
BSI 2021 22
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This document 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. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing materiasl 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. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 General considerations
13 5 Activities outside the laboratory
5.1 Specimen collection
5.1.1 Information about the specimen donor/patient
5.1.2 Selection of the saliva collection device by the laboratory
14 5.1.3 Saliva specimen collection from the donor/patient and stabilization procedures
15 5.1.4 Information on the specimen and storage requirements at saliva collection facility/site
16 5.2 Transport requirements
5.2.1 General
5.2.2 Using saliva collection devices with DNA stabilizers
5.2.3 Using saliva collection devices without DNA stabilizers
17 6 Activities inside the laboratory
6.1 Specimen reception
6.2 Storage requirements
6.3 Isolation of the saliva DNA
6.3.1 General
18 6.3.2 Using a commercial kit
6.3.3 Using the laboratory’s own protocol
6.4 Quantity and quality assessment of isolated DNA
19 6.5 Storage of isolated saliva DNA
6.5.1 General
6.5.2 Saliva DNA isolated with commercially available kits
6.5.3 Saliva DNA isolated with the laboratory’s own protocols
20 Bibliography

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BS EN ISO 4307:2021
$102.76