ISO 16578:2022

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

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ISO 16578:2022

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

PUBLISH DATE 2022
ISO 16578:2022

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.
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