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NBN ISO 21474-1:2021
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
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Summary
This document provides the terms and general requirements for the evaluation of the quality of nucleic
acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic
acid target sequences of interest. This document is applicable to all multiplex molecular methods used
for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs).
It provides information for both qualitative and quantitative detection of nucleic acid target sequences.
This document is intended as guidance for multiplex molecular assays that detect and/or quantify human
nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical
specimens. This document is applicable to any molecular in vitro diagnostic examination performed
by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics
developers and manufacturers, biobanks, institutions and commercial organizations performing
biomedical research, and regulatory authorities. This document is not applicable to metagenomics.
NOTE An examination procedure developed for a laboratory’s own use is often referred to as a “laboratory
developed test”, “LDT”, or “in-house test”.
acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic
acid target sequences of interest. This document is applicable to all multiplex molecular methods used
for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs).
It provides information for both qualitative and quantitative detection of nucleic acid target sequences.
This document is intended as guidance for multiplex molecular assays that detect and/or quantify human
nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical
specimens. This document is applicable to any molecular in vitro diagnostic examination performed
by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics
developers and manufacturers, biobanks, institutions and commercial organizations performing
biomedical research, and regulatory authorities. This document is not applicable to metagenomics.
NOTE An examination procedure developed for a laboratory’s own use is often referred to as a “laboratory
developed test”, “LDT”, or “in-house test”.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 05/13/2021 |
| Page Count | 5 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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