ISO FDIS 16578

Description / Abstract: This International Standard defines terms for the detection of nucleic acid sequence of interest using DNA microarrays for detection of nucleic acid. This International Standard is applicable to all methods that use microarrays for detection of nucleic acids.

This International Standard specifies the verification processes and parameters for molecular biology analysis, including the detection and identification of specific nucleic acid sequences.

This International Standard has been developed to provide recommendations and protocol 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, and

— criteria to assessing technical performance of the microarray platform. It does not cover the following protocols:

— the process of quantitative measurement;

— the requirements for sample preparation prior to DNA microarray experiments.