International Standard
ISO 16578:2022
Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences
Reference number
ISO 16578:2022
Edition 2
2022-09
International Standard
Read sample
ISO 16578:2022
80968
Published (Edition 2, 2022)

ISO 16578:2022

ISO 16578:2022
80968
Language
Format
CHF 96
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Abstract

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.

General information

  •  : Published
     : 2022-09
    : International Standard published [60.60]
  •  : 2
     : 14
  • ISO/TC 34/SC 16
    67.050 
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