BS ISO 16578:2022

Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences. | Status: Current

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.