| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4 Overview 4.1 SARS-CoV-2 4.1.1 General <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.1.2 Pre-examination 4.1.3 Examination \u2014 Overview <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.1.4 Post-examination 4.2 Nucleic acid amplification methods 4.2.1 Reverse transcription qPCR (RT-qPCR) <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 4.2.2 Reverse transcription digital PCR (RT-dPCR) 4.2.3 Isothermal amplification methods 5 Laboratory requirements 5.1 General <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.5 Design and development planning 6.5.1 Pre-examination of respiratory specimens for SARS-CoV-2 testing <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.5.2 Examination design specifications (analytical test specifications) <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 6.5.3 Design risk management <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 7.2.3 Inclusivity 7.2.4 Specificity 7.2.5 Robustness <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 7.3 Clinical evidence 8 Validation for patient care 8.1 General consideration 8.2 Clarification of the intended use <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 10.2 Reporting and interpretation of results <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 11 Quality assurance 11.1 Performance monitoring 11.2 Design change including optimization of analytical test <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | 11.3 Interlaboratory comparison <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Annex A (informative) Nucleic acid amplification techniques <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" 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<\/b><\/p>\n |