SSH ISO 16578:2013

Molecular biomarker analysis — General definitions and requirements for microarray detection of specific nucleic acid sequences

Scope

ISO 16578:2013 defines terms for the detection of nucleic acid sequence of interest using DNA microarrays for detection of nucleic acid.
It specifies the verification processes and parameters for molecular biology analysis, including the detection and identification of specific nucleic acid sequences.
ISO 16578:2013 provides 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.