GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1:Isolated RNA
GB/T 42080.1-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1:Isolated RNA
Basic Information
Scope
This document provides guidelines for the processing, recording, storage, and retrieval of frozen tissue samples used for RNA testing during the pre-analysis phase prior to molecular analysis. This document is applicable to any molecular in vitro diagnostic tests conducted in medical laboratories and molecular pathology laboratories on RNA extracted from frozen tissues. It is also applicable to laboratory clients, in vitro diagnostic developers and manufacturers, biobanks, institutions and commercial organizations conducting biomedical research, and regulatory authorities. This document does not include tissues that have undergone chemical stabilization pretreatment before freezing. Note: International, national, or regional regulations or requirements may also apply to the specific content covered in this document.