1 Scope
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:
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— microarray design and manufacture;
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— validation of hybridization specificity;
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— interlaboratory validation of qualitative methods;
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— determination of limits of detection for a microarray;
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— determination of range of reliable signals;
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— 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:
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— quantitative measurement;
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— requirements for sample preparation prior to DNA microarray experiments.