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BS ISO 16578:2022

BS ISO 16578:2022

$142.49

Molecular biomarker analysis — Requirements for microarray detection of specific nucleic acid sequences

Published By Publication Date Number of Pages
BSI 2022 24
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PDF Catalog

PDF Pages PDF Title
2 National foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Principle
4.1 DNA microarray platform assay
4.2 Microarray design and manufacture
4.2.1 General
4.2.2 Control probe sequences and targeted probes
12 4.2.3 Analytical power of microarray assay
4.3 Validation of hybridization specificity
4.3.1 Theoretical assessment of specificity
4.3.2 Experimental assessment of specificity
4.3.3 Experimental assessment of cross-hybridization
13 4.4 Interlaboratory validation of qualitative methods
4.4.1 General
4.4.2 Detection limit
14 4.4.3 Probability of detection
4.4.4 Limit of detection for microarray platform
4.4.5 Range of reliable signal
4.4.6 Test sample
4.4.7 Measuring system
15 4.4.8 Estimation of measurement uncertainty
4.4.9 Microarray reagents
5 Expression of results
5.1 General
5.2 Expression of a negative result
5.3 Expression of a positive result
16 5.4 Expression of inconclusive or ambiguous results
6 Test report
17 Annex A (informative) Practical determination of limit of detection for microarray platform (LODP)
21 Bibliography

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BS ISO 16578:2022
$142.49