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ISO 16578:2022

Current Revision

Molecular biomarker analysis - Requirements for microarray detection of specific nucleic acid sequences

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 16578
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 34/SC 16
Publish Date Document Id Type View
Not Available ISO 16578:2022 Revision