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About This Item
Full Description
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:
— quantitative measurement;
— requirements for sample preparation prior to DNA microarray experiments.
Document History
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ISO 16578:2022
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Molecular biomarker analysis - Requirements for microarray detection of specific nucleic acid sequences- Most Recent
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ISO 16578:2013
Molecular biomarker analysis - General definitions and requirements for microarray detection of specific nucleic acid sequences- Historical Version