ISO 17822:2020

INTERNATIONAL ISO
STANDARD 17822
First edition
2020-11
Corrected version
2020-12
In vitro diagnostic test systems —
Nucleic acid amplification-based
examination procedures for detection
and identification of microbial
pathogens — Laboratory quality
practice guide
Systèmes d'essai pour diagnostic in vitro — Modes opératoires
d'examen in vitro qualitatifs fondés sur l'acide nucléique pour la
détection et l'identification d'agents pathogènes microbiens — Guide
pratique sur la qualité dans les laboratoires
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General laboratory requirement for microbial pathogens NAAT .10
4.1 General laboratory risk management and biosafety requirements .10
4.2 General laboratory set ups for pathogen detection .10
4.3 Commercial equipment (including software programs) .12
4.4 Laboratory personnel .12
5 Planning and implementation of pathogen NAAT assay .12
5.1 Quality control material .13
5.1.1 Examination of quality control material .13
5.1.2 Defining target sequence .15
5.2 Verification and validation .16
6 Verification or validation of test systems .16
6.1 Predicate assay selection by method comparison.16
7 Assay design and development of LDT .17
7.1 General .17
7.1.1 Definition of customer/patient’s and stakeholder needs of the intended
use of the assay .17
7.1.2 General criteria for Verification of assay .18
7.1.3 Specific criteria for verification of assay design input specifications .18
7.1.4 Validation of intended use .19
7.2 Diagnostic workflow analysis for Nucleic NAAT procedure .19
7.2.1 Pre-analytical workflow requirements .19
7.2.2 Analytical workflow requirements .20
7.2.3 Post-analytical workflow requirements .22
7.3 Verification and validation performance characteristics .23
7.3.1 Range of detection .23
7.3.2 Test accuracy (Trueness and Precision) .23
7.4 Analytical sensitivity / limit of detection .25
7.4.1 Validation of assay .26
8 Implementation and use in the laboratory .27
9 Reporting and interpretation of results .27
10 Quality assurance procedures .28
10.1 Performance monitoring and optimization of the assay .28
10.2 Inter-laboratory comparison .29
Annex A (informative) Pre-analytical consideration for sample preparation .30
Annex B (informative) Verification and validation of assays .37
Bibliography .38
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 subject for which a technical
committee has been established has the right to be represented on that committee. International
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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 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/ 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 the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
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constitute an endorsement.
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expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in
vitro diagnostic test systems.
This first edition of ISO 17822 cancels and replaces ISO/TS 17822-1:2014, which has been technically
revised. The main changes are as follows:
— Clause 4 has been updated and merged from ISO/TS 17822-1:2014.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html
This corrected version of ISO 17822:2020 incorporates the following correction:
— The title on the cover page and page 1 has been corrected to remove the part name.
iv © ISO 2020 – All rights reserved

Introduction
Nucleic acid amplification-based tests (NAATs) are now commonly used in in vitro diagnostic (IVD)
tools in laboratory medicine for the detection, identification and quantification of microbial pathogens.
The NAAT result is influenced by all steps of the entire diagnostic workflow (i.e. pre-examination,
examination, post-examination). Therefore, this document considers all critical aspects of the entire
diagnostic workflow when designing, developing and implementing and using a specific microbial
pathogen NAAT examination.
NAAT examinations include PCR technology as well as other amplification-based technologies such
as, but not limited to, loop-mediated isothermal amplification (LAMP), transcription-mediated
amplification (TMA) and strand displacement amplification (SDA).
This document covers the implementation of commercially available IVD(s) into the medical laboratory
routine use as well as the design, development and implementation of laboratory developed tests (LDT).
This document will address the additional specific considerations, requirements and recommendations
for the detection of microbial pathogens with sampling, nucleic acid extraction, genetic heterogeneity
and the laboratory containment category which is required.
Due to high analytical sensitivity of nucleic acid-based examination procedures, special attention to
their design, development and use is required. This includes verification of analytical and validation of
clinical performance characteristics.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
INTERNATIONAL STANDARD ISO 17822:2020(E)
In vitro diagnostic test systems — Nucleic acid
amplification-based examination procedures for detection
and identification of microbial pathogens — Laboratory
quality practice guide
1 Scope
This document describes the particular clinical laboratory practice requirements to ensure the quality
of detection, identification and quantification of microbial pathogens using nucleic acid amplification
tests (NAAT).
It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for
medical, research or health-related purposes. This document does not apply to the development of in
vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and
validation of such devices and/or the corresponding processes when implemented and used by the
laboratories.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15189, Medical laboratories — Requirements for quality and competence
ISO 15190, Medical laboratories — Requirements for safety
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accuracy
closeness of agreement between a test result or measurement result and the true value
Note 1 to entry: In practice, the accepted reference value is substituted for the true value.
Note 2 to entry: The term “accuracy”, when applied to a set of test or measurement results, involves a combination
of random components and a common systematic error or bias component
...