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ISO 16578:2022

ISO 16578:2022 Molecular biomarker analysis - Requirements for microarray detection of specific nucleic acid sequences

standard by International Organization for Standardization, 09/30/2022

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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.

 
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