BS ISO 16577-2016 Molecular biomarker analysis Terms and definitions《分子生物标志物分析 术语和定义》.pdf

1、BSI Standards PublicationBS ISO 16577:2016Molecular biomarker analysis Terms and definitionsBS ISO 16577:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16577:2016.The UK participation in its preparation was entrusted to TechnicalCommittee AW/275, Food ana

2、lysis - Horizontal methods.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016

3、. Published by BSI StandardsLimited 2016ISBN 978 0 580 75166 0ICS 67.050Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2016.Amendments issued since publi

4、cationDate Text affectedBS ISO 16577:2016 ISO 2016Molecular biomarker analysis Terms and definitionsAnalyse molculaire de biomarqueurs Termes et dfinitionsINTERNATIONAL STANDARDISO16577First edition2016-03-15Reference numberISO 16577:2016(E)BS ISO 16577:2016ISO 16577:2016(E)ii ISO 2016 All rights re

5、servedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an in

6、tranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgww

7、w.iso.orgBS ISO 16577:2016ISO 16577:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 1 ISO 2016 All rights reserved iiiContents PageBS ISO 16577:2016ISO 16577:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national s

8、tandards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International

9、organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for

10、its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/

11、directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in

12、 the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions rel

13、ated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 34, Food products, Subcommittee SC 16, Horizontal

14、 methods for molecular biomarker analysis.iv ISO 2016 All rights reservedBS ISO 16577:2016INTERNATIONAL STANDARD ISO 16577:2016(E)Molecular biomarker analysis Terms and definitions1 ScopeThis International Standard gives the definition of terms used in the International Standards published in the fr

15、ame of ISO/TC 34/SC 16.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced documen

16、t (including any amendments) applies.ISO 13495, Foodstuffs Principles of selection and criteria of validation for varietal identification methods using specific nucleic acidISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)3 Terms and defini

17、tionsFor the purposes of this document, the terms and definitions given in ISO 13495, ISO/IEC Guide 99 and the following apply.3.1absolute errorresult of a measurement minus a true value of the measurand3.2accordancesimilarity of consistent results from a qualitative method (i.e. both positive or bo

18、th negative) from identical samples analyzed in the same laboratory in repeatability conditions3.3accuracyaccuracy of measurementmeasurement accuracycloseness of agreement between a measured quantity value and a true quantity value of a measurandNote 1 to entry: The concept “measurement accuracy” is

19、 not a quantity and is not given a numerical quantity value. A measurement is said to be more accurate when it offers a smaller measurement error.Note 2 to entry: The term “measurement accuracy” should not be used for measurement trueness and the term measurement precision should not be used for “me

20、asurement accuracy”, which, however, is related to both these concepts.Note 3 to entry: “Measurement accuracy” is sometimes understood as closeness of agreement between measured quantity values that are being attributed to the measurand.SOURCE: ISO/IEC Guide 99:2007, 2.133.4alleleone of several alte

21、rnate forms of a gene which occur at the same locus on homologous chromosomes and which become separated during meiosis and can be recombined following fusion of gametes ISO 2016 All rights reserved 1BS ISO 16577:2016ISO 16577:2016(E)3.5allele competitioncompetitive phenomenon that results in the pr

22、eferential amplification of one allelic sequence over another in a heterozygous or mixed sample during the application of nucleic acid amplification technologies such as PCRSOURCE: ISO 13495:2013, 3.6.1, modified3.6allele frequencyfrequency at which an allele appears on a specific locus in a populat

23、ionSOURCE: ISO 13495:2013, 3.6.2, modified3.7ampliconDNA sequence produced by a DNA-amplification technology, such as the PCR techniqueSOURCE: ISO 13495:2013, 3.3.1, modified3.8analytecomponent of a system to be analyzedNote 1 to entry: AOI is Analyte of Interest.3.9annealingpairing of complementary

24、 single strands of nucleic acids to form a double-stranded molecule3.10antibodyprotein (immunoglobulin) produced and secreted by B lymphocytes in response to a molecule recognised as foreign (antigen) and which is capable of binding to that specific antigenNote 1 to entry: Immunoglobulin is the comm

25、on synonym for antibody.3.11antibody selectivityability of an antibody to specifically bind to an antigenic determinant (epitope) but not to other similar structures on that or other antigens3.12antigensubstance that is recognized as foreign by the immune system and elicits an immune response throug

26、h stimulating antibody production3.13applicabilityanalytes, matrices, and concentrations for which an analytical approach may be used satisfactorily3.14applicability rangerange of quantificationrange of linearitydynamic rangeupper and lower limits of quantification as expressed by a set of reference

27、 materials (or dilutions) with a suitable level of precision and accuracy3.15backgroundintrinsic level of signal resulting from the instruments, reagents and consumables used in the reaction2 ISO 2016 All rights reservedBS ISO 16577:2016ISO 16577:2016(E)3.16baselinelevel of detection or the point at

28、 which a reaction reaches fluorescence or signal intensity above the background level3.17biasmeasurement biasestimate of a systematic measurement errorSOURCE: ISO/IEC Guide 99:2007, 2.183.18biotechnology-derived traitsee genetically engineered organism (3.73)3.19blocking reagentcompound used to satu

29、rate the residual unspecific binding sites3.20calibrationoperation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertai

30、nties, and in a second step, uses this information to establish a relation for obtaining a measurement result from an indicationNote 1 to entry: A calibration may be expressed by a statement, calibration function, calibration diagram, calibration curve, or calibration table. In some cases, it may co

31、nsist of an additive or multiplicative correction of the indication with associated measurement uncertainty.Note 2 to entry: Calibration should not be confused with adjustment of a measuring system, often mistakenly called “self-calibration”, nor with verification of calibration.SOURCE: ISO/IEC Guid

32、e 99:2007, 2.39, modified3.21certified reference materialCRMreference material, accompanied by documentation issued by an authoritative body and providing one or more specified property values with associated uncertainties and traceability, using valid proceduresEXAMPLE Human serum with assigned qua

33、ntity value for the concentration of cholesterol and associated measurement uncertainty stated in an accompanying certificate, used as a calibrator or measurement trueness control material.Note 1 to entry: Documentation is given in the form of a “certificate” (see ISO/IEC Guide 30).Note 2 to entry:

34、Procedures for the production and certification of certified reference materials are given, e.g. in ISO Guide 34 and ISO Guide 35.Note 3 to entry: In this definition, “uncertainty” covers both “measurement uncertainty” and “uncertainty associated with the value of the nominal property”, such as for

35、identity and sequence. “Traceability” covers both “metrological traceability of a value” and “traceability of a nominal property value”.Note 4 to entry: ISO/REMCO has an analogous definition (Accred. Qual. Assur.:2006) but uses the modifiers “metrological” and “metrologically” to refer to both quant

36、ity and nominal property.SOURCE: ISO/IEC Guide 99:2007, 5:14, modified ISO 2016 All rights reserved 3BS ISO 16577:2016ISO 16577:2016(E)3.22clonepopulation of cells, generated by asexual reproduction, that are genetically identical and direct descendants of a parent cell, derived from a single cell3.

37、23collaborative trialsee interlaboratory study (3.84)3.24complementary sequencecomplementarity is a property shared between two nucleic acid sequences, such that when they are aligned antiparallel to each other, the nucleotide bases at each position will be complementary3.25concordancesimilarity or

38、agreement of results (i.e. both positive or both negative) from identical samples that are analysed in two different laboratories in terms of qualitative analysis3.26construct-specific detection methodtargets a specific combination of inserted DNA sequences (such as genes, promoters, terminators or

39、other genetic elements of interest) unique to biotechnology-derived organisms3.27conventional quantity valueconventional value of a quantityconventional valueattributed by agreement to a quantity for a given purposeEXAMPLE 1 Standard acceleration of free fall (formerly called “standard acceleration

40、due to gravity”), gn= 9,806 65 ms2.EXAMPLE 2 Conventional quantity value of the Josephson constant, KJ-90= 483 597,9 GHz V-1.EXAMPLE 3 Conventional quantity value of a given mass standard, m = 100,003 47 g.Note 1 to entry: The term “conventional true quantity” is sometimes used for the concept but i

41、ts use is discouraged.Note 2 to entry: Sometimes, a conventional quantity value is an estimate of a true quantity value.Note 3 to entry: A conventional quantity value is generally accepted as being associated with a suitably small measurement uncertainty, which might be effectively considered to be

42、zero.SOURCE: ISO/IEC Guide 99:2007, 2.12, modified3.28copy numbernumber of molecules (copies) of a DNA sequence3.29critical valuevalue of the net concentration or amount, the exceeding of which leads, for a given error probability, , to the decision that the concentration or amount of the analyte in

43、 the analysed material is larger than that in the blank material:PrCLLL=()0 where4 ISO 2016 All rights reservedBS ISO 16577:2016ISO 16577:2016(E)Lis the estimated value;L is the expectation or true value;LCis the critical value.Note 1 to entry: The definition of critical value is important for defin

44、ing the Limit of Detection (LOD). The critical value LCis estimated by LC= t1-so, where t1-is Students-t, based on degrees of freedom for a one-sided confidence interval of 1 and sois the sample standard deviation.If L is normally distributed with known variance, i.e. = with the default of 0,05, LC=

45、 1,645so. A result falling below the LCtriggering the decision “not detected” should not be construed as demonstrating analyte absence.3.30cross-reactivitydegree to which binding occurs between an antibody and antigenic determinants which are not the analyte of primary interest3.31cultivargroup of c

46、ultivated plants which may be clearly defined by morphological, physical, cytological, chemical or other characteristics and which, after sexual or asexual reproduction, keeps its distinct characterNote 1 to entry: The concept of “cultivar” is essentially different from the concept of the botanical

47、variety “varietas”, in that “cultivar” is an infraspecific division resulting from controlled selection, even if empirical; “varietas” is an infraspecific division resulting from natural selection. The terms “cultivar” and “variety” (in the sense of cultivated variety) are equivalent. In translation

48、s or adaptations of botanical nomenclature for particular uses, the terms “cultivar” or “variety” (or their equivalents in other languages) may be used in text.3.32cycle thresholdCtin real-time quantitative PCR, the cycle at which the fluorescence from the reaction crosses a specified threshold leve

49、l at which the signal can be distinguished from background levels3.33denaturationprocess of partial or total alteration of the native structure of a macromolecule resulting from the loss of tertiary and/or secondary structure that is a consequence of the disruption of stabilizing weak bondsEXAMPLE Denaturation can occur when proteins and nucleic acids are subjected to elevated temperature, extremes of pH, non-physiological concentrations of salt, organic solvents, urea or other chemical agents.3.34denaturation