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BSI PD ISO/TS 5798:2022

BSI PD ISO/TS 5798:2022

$198.66

In vitro diagnostic test systems. Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods

Published By Publication Date Number of Pages
BSI 2022 54
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
15 4 Overview
4.1 SARS-CoV-2
4.1.1 General
17 4.1.2 Pre-examination
4.1.3 Examination — Overview
19 4.1.4 Post-examination
4.2 Nucleic acid amplification methods
4.2.1 Reverse transcription qPCR (RT-qPCR)
20 4.2.2 Reverse transcription digital PCR (RT-dPCR)
4.2.3 Isothermal amplification methods
5 Laboratory requirements
5.1 General
21 5.2 Biosafety requirements
5.2.1 Laboratory area
5.2.2 Risk control
5.2.3 Personal protective equipment (PPE)
5.3 General laboratory set-up
22 5.4 Instrumentation
5.5 Laboratory personnel
6 Design and development
6.1 Customer, patient and stakeholder needs
6.2 Intended use of analytical test
23 6.3 Institutional guideline strategy
6.3.1 Laboratory developed tests (LDTs) versus in vitro diagnostic medical devices (IVD medical devices)
6.3.2 Emergency use authorization
6.4 Clinical strategy
24 6.5 Design and development planning
6.5.1 Pre-examination of respiratory specimens for SARS-CoV-2 testing
30 6.5.2 Examination design specifications (analytical test specifications)
35 6.5.3 Design risk management
36 6.6 Optimization of reagents and methods
6.6.1 Selection of SARS-CoV-2 target sequences
6.6.2 Potential impact of variants of concern (VOCs) on the quality of NAAT diagnostic methods for detecting SARS-CoV-2
6.6.3 Selection of amplification methods
6.6.4 Design and selection of primers
37 6.6.5 Optimization of the reaction system
6.6.6 Determination of cut-off values
6.6.7 Verification and validation of test design
39 7 Verification for patient care
7.1 General
7.2 Confirmation of analytical performance characteristics
7.2.1 Accuracy
7.2.2 Limit of detection (LOD)
40 7.2.3 Inclusivity
7.2.4 Specificity
7.2.5 Robustness
41 7.3 Clinical evidence
8 Validation for patient care
8.1 General consideration
8.2 Clarification of the intended use
42 8.3 Performance with clinical specimens or samples
9 Design transfer to production
10 Implementation and use in the laboratory and reporting of results
10.1 Implementation and use in the laboratory
43 10.2 Reporting and interpretation of results
44 11 Quality assurance
11.1 Performance monitoring
11.2 Design change including optimization of analytical test
45 11.3 Interlaboratory comparison
46 Annex A (informative) Nucleic acid amplification techniques
49 Bibliography

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BSI PD ISO/TS 5798:2022
$198.66