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BS ISO 17822:2020:2021 Edition

BS ISO 17822:2020:2021 Edition

$189.07

In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide

Published By Publication Date Number of Pages
BSI 2021 48
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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.

PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
7 Introduction
8 1 Scope
2 Normative references
3 Terms and definitions
17 4 General laboratory requirement for microbial pathogens NAAT
4.1 General laboratory risk management and biosafety requirements
4.2 General laboratory set ups for pathogen detection
19 4.3 Commercial equipment (including software programs)
4.4 Laboratory personnel
5 Planning and implementation of pathogen NAAT assay
20 5.1 Quality control material
5.1.1 Examination of quality control material
22 5.1.2 Defining target sequence
23 5.2 Verification and validation
6 Verification or validation of test systems
6.1 Predicate assay selection by method comparison
24 7 Assay design and development of LDT
7.1 General
7.1.1 Definition of customer/patient’s and stakeholder needs of the intended use of the assay
25 7.1.2 General criteria for Verification of assay
7.1.3 Specific criteria for verification of assay design input specifications
26 7.1.4 Validation of intended use
7.2 Diagnostic workflow analysis for Nucleic NAAT procedure
7.2.1 Pre-analytical workflow requirements
27 7.2.2 Analytical workflow requirements
29 7.2.3 Post-analytical workflow requirements
30 7.3 Verification and validation performance characteristics
7.3.1 Range of detection
7.3.2 Test accuracy (Trueness and Precision)
32 7.4 Analytical sensitivity / limit of detection
33 7.4.1 Validation of assay
34 8 Implementation and use in the laboratory
9 Reporting and interpretation of results
35 10 Quality assurance procedures
10.1 Performance monitoring and optimization of the assay
36 10.2 Inter-laboratory comparison
37 Annex A (informative) Pre-analytical consideration for sample preparation
44 Annex B (informative) Verification and validation of assays
45 Bibliography

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BS ISO 17822:2020
$189.07