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ISO 16578:2022

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

Standard Details

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

Status : Published
Standard Type: Main
Document No: ISO 16578:2022
Document Year: 2022
Pages: 14
Edition: 2
  • Section Volume:
  • ISO/TC 34/SC 16. Horizontal methods for molecular biomarker analysis
  • ICS:
  • 67.050 General methods of tests and analysis for food products

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ISO 16578:2022
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