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).<\/p>\n
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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.3 Commercial equipment (including software programs) 4.4 Laboratory personnel 5 Planning and implementation of pathogen NAAT assay <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.1 Quality control material 5.1.1 Examination of quality control material <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.1.2 Defining target sequence <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2 Verification and validation 6 Verification or validation of test systems 6.1 Predicate assay selection by method comparison <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 7 Assay design and development of LDT 7.1 General 7.1.1 Definition of customer\/patient\u2019s and stakeholder needs of the intended use of the assay <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.1.2 General criteria for Verification of assay 7.1.3 Specific criteria for verification of assay design input specifications <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7.1.4 Validation of intended use 7.2 Diagnostic workflow analysis for Nucleic NAAT procedure 7.2.1 Pre-analytical workflow requirements <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7.2.2 Analytical workflow requirements <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.2.3 Post-analytical workflow requirements <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 7.3 Verification and validation performance characteristics 7.3.1 Range of detection 7.3.2 Test accuracy (Trueness and Precision) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 7.4 Analytical sensitivity \/ limit of detection <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 7.4.1 Validation of assay <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 8 Implementation and use in the laboratory 9 Reporting and interpretation of results <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 10 Quality assurance procedures 10.1 Performance monitoring and optimization of the assay <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 10.2 Inter-laboratory comparison <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex A (informative) Pre-analytical consideration for sample preparation <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Annex B (informative) Verification and validation of assays <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" In vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide<\/b><\/p>\n |