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BS ISO 16578:2022 – TC

BS ISO 16578:2022 – TC

$186.33

Tracked Changes. Molecular biomarker analysis. Requirements for microarray detection of specific nucleic acid sequences

Published By Publication Date Number of Pages
BSI 2022 50
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PDF Catalog

PDF Pages PDF Title
1 30464746
27 A-30446079
28 National foreword
32 Foreword
33 Introduction
35 1 Scope
2 Normative references
3 Terms and definitions
37 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
38 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
39 4.4 Interlaboratory validation of qualitative methods
4.4.1 General
4.4.2 Detection limit
40 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
41 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
42 5.4 Expression of inconclusive or ambiguous results
6 Test report
43 Annex A (informative) Practical determination of limit of detection for microarray platform (LODP)
47 Bibliography

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BS ISO 16578:2022 - TC
$186.33