BS EN ISO 20184-1:2018 pdf free download.Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue – Part1:Isolated RNA.
Molecular in vitro diagnostics, including molecular pathology, has enabled a significant progress in medicine. Further progress is expected with new technologies analysing nucleic acids, proteins, and metahoiftes in human tissues and body fluids. However, the profiles and/or integrity of these molecules can change drastically during specimen collection, transport, storage, and processing thus making the outcome from diagnostics or research unreliable or even impossible because the subsequent examination assay will not determine the situation in the patient but an artificial profile generated during the pre-examination process.
Therefore, a standardization of the entire process from specimen collection to the RNA examination is needed. Studies have been undertaken to determine the important influencing factors. This document draws upon such work to codify and standardize the steps for frozen tissue with regard to RNA examination in what is referred to as the pre-examination phase.
RNA profiles in tissues can change drastically before, during and after collection (due to e.g. gene induction or gene down regulation). RNA species can change differently in different donor’s patients’ tissues.
Therefore, it is essential to take special measures to minimize the described RNA profile changes and modifications within the tissue for subsequent examination.This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-exarnination phase before a molecular assay is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE: International, national or regional regulations or requirements can also apply to specific topics covered in this document.BS EN ISO 20184-1:2018 pdf free download.