ISO 16578:2022
ISO 16578:2022
Molecular biomarker analysis - Requirements for microarray detection of specific nucleic acid sequencesstandard by International Organization for Standardization, 09/30/2022
standard by International Organization for Standardization, 09/30/2022
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: