1 Scope
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.
BS ISO 16578:2022 history
2022BS ISO 16578:2022 Molecular biomarker analysis. Requirements for microarray detection of specific nucleic acid sequences
2013BS ISO 16578:2013 Molecular biomarker analysis. General definitions and requirements for microarray detection of specific nucleic acid sequences