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ISO 16578:2022
Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences
SKU: iso_080968_184158
Published by ISO
Publication Year 2022
2 Edition
14 pages
Product Details
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.
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.
