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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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Availability date: 2023-10-16
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: