ISO 16578:2022 PDF

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.

ISO 16578:2022 Referenced Document

ISO 16577 Molecular biomarker analysis — Vocabulary for molecular biomarker analytical methods in agriculture and food production
ISO/TS 16393 Molecular biomarker analysis — Determination of the performance characteristics of qualitative measurement methods and validation of methods

2022 ISO 16578:2022 Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences
2013 ISO 16578:2013 Molecular biomarker analysis - General definitions and requirements for microarray detection of specific nucleic acid sequences