ISO 16578:2022

Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences
Autor: ISO
Código ICS: 67.050
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Alcance

This document specifies verification and validation parameters and processes for microarray detection and identification of specific nucleic acid sequences.This document provides recommendations and protocols for:—    microarray design and manufacture;—    validation of hybridization specificity;—    interlaboratory validation of qualitative methods;—    determination of limits of detection for a microarray;—    determination of range of reliable signals;—    criteria for assessing technical performance of the microarray platform:This document is applicable to all methods that use microarrays for detection of nucleic acids.It does not apply to the following protocols:—    quantitative measurement;—    requirements for sample preparation prior to DNA microarray experiments.

Especificaciones de la Norma
Fecha de Publicación 28/09/2022
Título Secundario Analyse moléculaire des biomarqueurs — Exigences relatives à la détection sur microréseaux de séquences d'acides nucléiques spécifiques
Páginas Técnicas 14
Idioma Inglés