ISO 16578:2022 Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences

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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.
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Status: Active Change number: 2 International classification code of standards (ICS): 67.050 Technical committee: ISO/TC 34/SC 16 Activated date: 28.09.2022 Pages count: 14 Language: en

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