NF ISO 16578, V03-503 (10/2023)

This document specifies verification and validation parameters and methods for the detection and identification of specific nucleic acid sequences using microarrays. It provides recommendations and protocols for: — the design and fabrication of a microgrid; — validation of hybridization specificity; — interlaboratory validation of qualitative methods; — determination of detection limits for a microarray; — determination of a reliable signal range; — the criteria for evaluating the technical performance of the microgrid support. It is applicable to all methods that use microarrays for nucleic acid detection. It does not apply to the following protocols: — quantitative measurement; — requirements for sample preparation prior to DNA microarray experiments.
(Automatic translation from French)