This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.<\/p>\n
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.<\/p>\n
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.<\/p>\n
International, national, or regional regulations or requirements can also apply to specific topics covered in this document.<\/p>\n<\/div>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 General considerations <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5 Outside the laboratory 5.1 Specimen collection 5.1.1 General 5.1.2 Information about the patient\/specimen donor 5.1.3 Information about the specimen 5.1.4 Specimen processing <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5.2 Fresh tissue transport requirements 5.2.1 General 5.2.2 Preparations for the transport <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.2.3 During transport 6 Inside the laboratory 6.1 Information about the reception of the specimen 6.2 Evaluation of the pathology of the specimen and selection of the sample(s) <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6.3 Freezing of the specimen or sample(s) <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.4 Storage requirements 6.5 DNA isolation 6.5.1 General <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 6.5.2 Using commercial kits 6.5.3 Using laboratory developed protocols 6.6 Quantity and quality assessment of isolated DNA <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 6.7 Storage of isolated DNA <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue – Isolated DNA<\/b><\/p>\n |