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1、BSI Standards PublicationPD ISO/TS 17822-1:2014In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogensPart 1: General requirements, terms and definitionsPD ISO/TS 17822-1:2014 PUBLISHED DOCUMENTNational f

2、orewordThis Published Document is the UK implementation of ISO/TS 17822-1:2014.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport

3、 to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 89200 4ICS 01.040.19; 11.100.01Compliance with a British Standard cannot confer immunity from legal

4、obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 December 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dPD ISO/TS 17822-1:2014 ISO 2014In vitro diagnostic test systems Qualitative nucleic acid-

5、based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitionsSystmes dessai pour diagnostic in vitro Modes opratoires dexamen in vitro qualitatifs fonds sur lacide nuclique pour la dtection et lidentification dagents

6、 pathognes microbiens Partie 1: Exigences gnrales, termes et dfinitionsTECHNICAL SPECIFICATIONISO/TS17822-1Reference numberISO/TS 17822-1:2014(E)First edition2014-12-15PD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved.

7、 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 intranet, without prior written permission. Permission can be requested from either ISO at

8、the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandPD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)Contents PageForeword ivIntr

9、oduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Principles of nucleic acid based in vitro diagnostic examinations . 94.1 General requirements . 94.1.1 Design and development 94.1.2 Implementation and use in the medical laboratory .104.2 Specimen collection, transport, and s

10、torage conditions 114.3 Selection of nucleic acid targets and sequences .114.4 Selection of primers or primer sequences . 114.5 Nucleic acid preparation and stability . 124.6 Nucleic acid amplification 124.7 Nucleic acid detection and identification 124.8 Reagent stability and storage conditions 125

11、 Performance characteristics .135.1 General requirements 135.1.1 Design and development . 135.1.2 Implementation and use in the medical laboratory .135.2 Specific requirements 145.2.1 Cut-off values . 145.2.2 Detection Limit .145.2.3 Analytical specificity 145.2.4 Measurement precision 145.2.5 Clini

12、cal performance .155.3 Quality control and quality assurance procedures .155.3.1 Control materials 155.3.2 Medical laboratory design and workflow 165.3.3 Medical laboratory practices 165.3.4 Commercial equipment (including software)165.3.5 Medical laboratory personnel . 175.3.6 Quality assurance pro

13、cedures . 175.4 Reporting of results . 176 Risk management .176.1 General 176.2 Design and development risk management . 186.3 Medical laboratory risk management 18Bibliography .20 ISO 2014 All rights reserved iiiPD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)ForewordISO (the International Organization

14、 for Standardization) is a worldwide federation of national standards 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

15、the right to be represented on that committee. International 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 pro

16、cedures used to develop this document and those intended for 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 editor

17、ial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/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

18、 identified during the development of the document will be in 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 explana

19、tion on the meaning of ISO specific terms and expressions related 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 information .The committee responsible for this docume

20、nt is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.ISO/TS 17822 consists of the following parts, under the general title In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial patho

21、gens: Part 1: General requirements, terms and definitions Part 2: Quality practice guide for medical laboratoriesiv ISO 2014 All rights reservedPD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)IntroductionNucleic acid-based in vitro diagnostic examination procedures are now commonly used in laboratory me

22、dicine for the detection and identification of microbial pathogens. These examination procedures have become particularly valuable for the detection of infectious agents that are difficult to grow in culture. For a review of recent advances and current practices associated with in vitro diagnostic e

23、xamination procedures based on nucleic acid-amplification and detection technology (“molecular diagnostics”), see References 38, 35, 36, 37, 39, 41, and 42.ISO/TS 17822-1 defines concepts and establishes general principles for the design, development, and performance of qualitative nucleic acid-base

24、d in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.Traditional PCR examination procedures typically consist of three steps: (1) sample preparation and nucleic acid extraction, (2) nucleic acid amplification, and (3) nucleic acid detectio

25、n and identification. The analytical technology is continuing to evolve. Recent kinetic approaches (“real-time PCR”) incorporate detection in the amplification step, and multiplex PCR includes the entire system in a cassette.Due to the inherent complexity and unparalleled analytical sensitivity of n

26、ucleic acid-based examination procedures, special attention to their design, development, and use is required, including determination of analytical and clinical performance characteristics, documentation of instructions for use, design of medical laboratory facilities, implementation of appropriate

27、 quality assurance practices, verification of the performance characteristics by the medical laboratory in conditions of actual use, and risk management.As with all in vitro diagnostic examination procedures, suitability of a nucleic acid-based examination procedure for its intended clinical uses mu

28、st be demonstrated as part of the development process. Analytical performance characteristics must be determined and validated for the detection and identification of the target pathogen. Clinical performance characteristics must be determined and validated based on clinical evidence, including eval

29、uation of the benefits and risks to patients. Instructions for use must be clearly documented and effective quality assurance procedures must be specified.Prior to examination of patient specimens, satisfactory implementation of the examination procedure must be verified by the medical laboratory un

30、der conditions of actual use. In other words, the successful transfer of the validated examination procedure from the development laboratory or IVD manufacturer to the end-user medical laboratory must be demonstrated by objective evidence. Any modification of the examination procedure after this tra

31、nsfer may require validation that the analytical and/or clinical performance remains suitable for its intended uses, including reassessment of any risks that could be affected by the modification. ISO 2014 All rights reserved vPD ISO/TS 17822-1:2014PD ISO/TS 17822-1:2014In vitro diagnostic test syst

32、ems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions1 ScopeThis Technical Specification is intended for IVD medical device manufacturers, medical laboratories, and research and d

33、evelopment laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection a

34、nd identification of microbial pathogens in human specimens.This part of ISO/TS 17822 does not apply to nucleic acid-based examinations that are not intended for in vitro diagnostic use, or quantitative nucleic acid-based in vitro diagnostic examination procedures.2 Normative referencesThe following

35、 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 document (including any amendments) applies.ISO 13485:2003, Medic

36、al devices Quality management systems Requirements for regulatory purposesISO 14971:2007, Medical devices Application of risk management to medical devicesISO 15189:2012, Medical laboratories Requirements for quality and competenceISO 15190:2003, Medical laboratories Requirements for safetyISO 18113

37、-1:2009, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirementsISO 18113-2:2009, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for pro

38、fessional useISO 18113-3:2009, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional useISO 23640:2011, In vitro diagnostic medical devices Evaluation of stability of in vitro diagnostic reagentsBIPM JCGM 200

39、:2012, International vocabulary of metrology Basic and general concepts and associated terms (VIM), 3rd editionTECHNICAL SPECIFICATION ISO/TS 17822-1:2014(E) ISO 2014 All rights reserved 1PD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)3 Terms and definitionsFor the purposes of this document, the terms

40、and definitions given in ISO 13485, ISO 14971, ISO 15189, ISO 18113-1, JCGM 200, and the following apply.NOTE The terms and definitions given in ISO 18113-1 take precedence over other sources.3.1amplification productampliconnucleic acid products created from a target amplification reactionNote 1 to

41、entry: Amplicons will be double-stranded DNA if created by a PCR reaction and will be primarily single-stranded RNA if created in a nucleic acid sequence-based amplification or transcription-mediated amplification reaction.3.2analytical performanceability of an examination procedure to measure or de

42、tect a particular analyteSOURCE: GHTF/SG5/N 6:2012, 4.4.1, modified.Note 1 to entry: Analytical performance is determined from analytical performance studies used to assess the ability of an in vitro diagnostic examination procedure to measure or detect a particular analyte.Note 2 to entry: Analytic

43、al performance characteristics can include analytical sensitivity, detection limit, analytical specificity (interference and cross-reactivity), trueness, precision, and linearity.3.3analytical specificitycapability of a measuring system, using a specified measurement procedure, to provide measuremen

44、t results for one or more measurands which do not depend on each other nor on any other quantity in the system undergoing measurementSOURCE: ISO 18113-1:2009, A.3.4Note 1 to entry: Lack of analytical specificity is called analytical interference (see ISO 18113-1:2009, A.3.2).Note 2 to entry: Lack of

45、 analytical specificity in immunochemistry measurement procedures can be due to cross-reactivity (see ISO 18113-1:2009, A.3.12).Note 3 to entry: Specificity of a measurement procedure should not be confused with clinical specificity (see ISO 18113-1:2009, A.3.16).Note 4 to entry: JCGM 200:2008 uses

46、the term selectivity for this concept instead of specificity.Note 5 to entry: For qualitative and semiquantitative examination procedures, analytical specificity is determined by the ability to obtain negative results in concordance with negative results obtained by the reference method.3.4annealing

47、process of hybridization of complementary strands of nucleic acid under specific conditions, for example, as in binding of a primer or a probe to the complementary target nucleic acid sequenceSOURCE: ISO 22174:2005, 3.4.152 ISO 2014 All rights reservedPD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)3.5c

48、linical accuracydiagnostic accuracy(laboratory medicine) ability of an examination procedure to differentiate between patients who have a specific condition and those who do not have the conditionSOURCE: CLSI EP29-ANote 1 to entry: Measures of clinical accuracy include clinical sensitivity and clini

49、cal specificity.Note 2 to entry: Clinical accuracy is affected by the prevalence of the target disease or condition. With the same sensitivity and specificity, clinical accuracy of a particular examination procedure increases as the disease prevalence decreases.3.6clinical evaluation(laboratory medicine) assessment and analysis of clinical evidence in order to verify the clinical safety and performance of an in vitro diagnostic examination procedureSOURCE: Based on GHTF/SG5/N2R8:2007