Molecular biomarker analysis — General definitions and requirements for microarray detection of specific nucleic acid sequences

Available format(s)

Hardcopy , PDF

Superseded date

10-27-2022

Language(s)

English

Published date

11-30-2013

Publisher

British Standards Institution

Committee	AW/275
DevelopmentNote	Supersedes 12/30245291 DC. (11/2013)
DocumentType	Standard
Pages	16
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS ISO 16578:2022
Supersedes	12/30245291 DC : 0

This International Standard defines terms for the detection of nucleic acid sequence of interest using DNA microarrays for detection of nucleic acid.

This International Standard is applicable to all methods that use microarrays for detection of nucleic acids.

This International Standard specifies the verification processes and parameters for molecular biology analysis, including the detection and identification of specific nucleic acid sequences.

This International Standard has been developed to provide recommendations and protocol 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, and
criteria to assessing technical performance of the microarray platform.

It does not cover the following protocols:

the process of quantitative measurement;
the requirements for sample preparation prior to DNA microarray experiments.

Standards	Relationship
ISO 16578:2013	Identical

ISO 22174:2005	Microbiology of food and animal feeding stuffs Polymerase chain reaction (PCR) for the detection of food-borne pathogens General requirements and definitions
ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 5725-1:1994	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO 24276:2006	Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 5725-2:1994	Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
ISO/IEC Guide 98-3:2008	Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)