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STN P CEN/TS 17981-2

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Name: STN P CEN/TS 17981-2
Validity: Valid
Number of pages: 68
Language:
EN
Paper: 24,40€
Electronic version a) Only read (without ability to print and copy) 21,96€
b) Without ability to print, with ability to copy (printscreen) 24,40€
c) With ability to print and copy (printscreen) 31,72€
Slovak title Pracovné postupy na diagnostiku in vitro metódou sekvenovania novej generácie. Časť 2: Vyšetrenie ľudskej RNA
English title In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 2: Human RNA examination
Release Date: 01. 03. 2024
Date of withdrawal:
ICS: 11.100.10
Sorting character/National clasification code 85 1050
Level of incorporation: idt CEN/TS 17981-2:2023
Official Journal 02/24
Amendments
Replaced by:
Repleces:
Note in Official Journal: Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do novembra 2025 Úradu pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky.
Subject of the standard: This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories.
Preview: Náhľad normy (PDF)