1、BSI Standards Publication PD ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid- based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitionsPD ISO/TS 17822-1:2014 PUBLISHED DOCUMENT Natio
2、nal foreword This 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 no
3、t purport 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 2014 ISBN 978 0 580 89200 4 ICS 01.040.19; 11.100.01 Compliance with a British Standard cannot confer immunit
4、y from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 December 2014. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dPD ISO/TS 17822-1:2014 ISO 2014 In vitro diagnostic test systems Qualitat
5、ive nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions Systmes dessai pour diagnostic in vitro Modes opratoires dexamen in vitro qualitatifs fonds sur lacide nuclique pour la dtection et liden
6、tification dagents pathognes microbiens Partie 1: Exigences gnrales, termes et dfinitions TECHNICAL SPECIFICATION ISO/TS 17822-1 Reference number ISO/TS 17822-1:2014(E) First edition 2014-12-15PD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT IS
7、O 2014 All 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 intranet, without prior written permission. Permission can be re
8、quested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandPD ISO/TS 17822-1:2014ISO/TS 17822-1:2
9、014(E)Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Terms and definitions . 2 4 Principles of nucleic acid based in vitro diagnostic examinations .9 4.1 General requirements . 9 4.1.1 Design and development 9 4.1.2 Implementation and use in the medical laboratory .1
10、0 4.2 Specimen collection, transport, and storage conditions 11 4.3 Selection of nucleic acid targets and sequences .11 4.4 Selection of primers or primer sequences .11 4.5 Nucleic acid preparation and stability .12 4.6 Nucleic acid amplification 12 4.7 Nucleic acid detection and identification 12 4
11、.8 Reagent stability and storage conditions 12 5 Performance characteristics .13 5.1 General requirements 13 5.1.1 Design and development .13 5.1.2 Implementation and use in the medical laboratory .13 5.2 Specific requirements 14 5.2.1 Cut-off values .14 5.2.2 Detection Limit .14 5.2.3 Analytical sp
12、ecificity 14 5.2.4 Measurement precision 14 5.2.5 Clinical performance .15 5.3 Quality control and quality assurance procedures .15 5.3.1 Control materials 15 5.3.2 Medical laboratory design and workflow 16 5.3.3 Medical laboratory practices 16 5.3.4 Commercial equipment (including software)16 5.3.5
13、 Medical laboratory personnel .17 5.3.6 Quality assurance procedures .17 5.4 Reporting of results .17 6 Risk management .17 6.1 General 17 6.2 Design and development risk management .18 6.3 Medical laboratory risk management 18 Bibliography .20 ISO 2014 All rights reserved iiiPD ISO/TS 17822-1:2014I
14、SO/TS 17822-1:2014(E) Foreword ISO (the International Organization 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
15、 subject for which a technical committee has been established has 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 Commissio
16、n (IEC) on all matters of electrotechnical standardization. The procedures 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 shoul
17、d be noted. This document was drafted in accordance with the editorial 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 ide
18、ntifying any or all such patent rights. Details of any patent rights 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 conve
19、nience of users and does not constitute an endorsement. For an explanation 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: Forewor
20、d Supplementary information. The committee responsible for this document 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 exa
21、mination procedures for detection and identification of microbial pathogens: 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) Introduction Nucleic acid-based in vitro
22、 diagnostic examination procedures are now commonly used in laboratory medicine 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 re
23、cent advances and current practices associated with in vitro diagnostic examination 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
24、 the design, development, and performance of qualitative nucleic acid-based 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 aci
25、d extraction, (2) nucleic acid amplification, and (3) nucleic acid detection 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.
26、 Due to the inherent complexity and unparalleled analytical sensitivity of nucleic 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
27、 use, design of medical laboratory facilities, implementation of appropriate 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
28、 a nucleic acid-based examination procedure for its intended clinical uses must 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 characteristic
29、s must be determined and validated based on clinical evidence, including evaluation 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 implementat
30、ion of the examination procedure must be verified by the medical laboratory under 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 ob
31、jective evidence. Any modification of the examination procedure after this transfer 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 reser
32、ved vPD ISO/TS 17822-1:2014PD ISO/TS 17822-1:2014In vitro diagnostic test systems Qualitative nucleic acid- based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions 1 Scope This Technical Specification is intend
33、ed for IVD medical device manufacturers, medical laboratories, and research and development 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 tha
34、t perform nucleic acid-based in vitro diagnostic examinations for the detection and 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-ba
35、sed in vitro diagnostic examination procedures. 2 Normative references The 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
36、 of the referenced document (including any amendments) applies. ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 15189:2012, Medical laboratories Requirements for qual
37、ity and competence ISO 15190:2003, Medical laboratories Requirements for safety ISO 18113-1:2009, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements ISO 18113-2:2009, In vitro diagnostic medical devices Informa
38、tion supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use ISO 18113-3:2009, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use ISO 23640:2011, In vitro dia
39、gnostic medical devices Evaluation of stability of in vitro diagnostic reagents BIPM JCGM 200:2012, International vocabulary of metrology Basic and general concepts and associated terms (VIM), 3rd edition TECHNICAL SPECIFICATION ISO/TS 17822-1:2014(E) ISO 2014 All rights reserved 1PD ISO/TS 17822-1:
40、2014ISO/TS 17822-1:2014(E) 3 Terms and definitions For the purposes of this document, the terms 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. 3.1 amplif
41、ication product amplicon nucleic acid products created from a target amplification reaction Note 1 to 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-mediat
42、ed amplification reaction. 3.2 analytical performance ability of an examination procedure to measure or detect a particular analyte SOURCE: 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 i
43、n vitro diagnostic examination procedure to measure or detect a particular analyte. Note 2 to entry: Analytical performance characteristics can include analytical sensitivity, detection limit, analytical specificity (interference and cross-reactivity), trueness, precision, and linearity. 3.3 analyti
44、cal specificity capability of a measuring system, using a specified measurement procedure, to provide measurement results for one or more measurands which do not depend on each other nor on any other quantity in the system undergoing measurement SOURCE: ISO 18113-1:2009, A.3.4 Note 1 to entry: Lack
45、of analytical specificity is called analytical interference (see ISO 18113-1:2009, A.3.2). Note 2 to entry: Lack of 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
46、 should not be confused with clinical specificity (see ISO 18113-1:2009, A.3.16). Note 4 to entry: JCGM 200:2008 uses the term selectivity for this concept instead of specificity. Note 5 to entry: For qualitative and semiquantitative examination procedures, analytical specificity is determined by th
47、e ability to obtain negative results in concordance with negative results obtained by the reference method. 3.4 annealing 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
48、 acid sequence SOURCE: ISO 22174:2005, 3.4.152 ISO 2014 All rights reservedPD ISO/TS 17822-1:2014ISO/TS 17822-1:2014(E) 3.5 clinical accuracy diagnostic accuracy (laboratory medicine) ability of an examination procedure to differentiate between patients who have a specific condition and those who do
49、 not have the condition SOURCE: CLSI EP29-A Note 1 to entry: Measures of clinical accuracy include clinical sensitivity and clinical 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. 3.6 clinical evaluation (laboratory medicine) assessment and analysis of clinical
