BSI PD CEN/TS 17688-3:2021

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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) – Isolated genomic DNA

Published By	Publication Date	Number of Pages
BSI	2021	40

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Categories: 11.100.10 - In vitro diagnostic test systems, BSI

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This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for gDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine gDNA isolated from FNAs. 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. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but EN ISO 20184-3, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA and EN ISO 20166-3, Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 3: Isolated DNA. This document is not applicable for pathogen DNA examination and gDNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages	PDF Title
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15	5.1.1 General
16	5.1.2 Information about the patient/specimen donor 5.1.3 Information about the specimen 5.1.4 Selection of the primary FNA collection devices 5.1.5 FNA specimen collection and stabilization from the donor/patient 5.1.5.1 General
17	5.1.5.2 FNA specimen/sample collection with stabilizers
18	5.1.5.3 FNA specimen/sample collection without stabilizers
19	6.2.1 General 6.2.2 Storage of FNA specimen/samples with stabilizer 6.2.3 Storage of FNA specimen/samples using collection devices without stabilizers
20	6.3.1 General 6.3.2 Handling of cell suspension
21	6.3.3 Preparation of paraffin-embedded cell blocks
22	6.3.4 Preparation of cell suspension slides
23	6.5.1 General 6.5.2 Storage and transport of cell suspension 6.5.3 Storage and transport of paraffin-embedded cell blocks
24	6.5.4 Storage and transport of cell suspension slides 6.6.1 General
25	6.6.2 Using a commercial gDNA isolation kit intended for diagnostic use 6.6.3 Using the laboratory’s own gDNA isolation procedure 6.6.4 Isolation of gDNA from specific sample types 6.6.4.1 Isolation of gDNA from cell suspension
26	6.6.4.2 Isolation of gDNA from paraffin-embedded cell blocks 6.6.4.3 Isolation of gDNA from slides 6.7.1 General
27	6.7.2 Quantity assessment 6.7.3 Quality assessment 6.8.1 General