What is ISO 20184-1- Isolated RNA for pre-examination processes about?
ISO 20184 is an international standard that discusses pre-examination processes for frozen tissue for molecular in vitro diagnostic examinations. ISO 20184-1 provides the best industry guidance on Isolated RNA to ensure reliable results are produced that are comparable to other laboratories.
ISO 20184-1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
ISO 20184-1 assist in codifying and standardizing the steps for frozen tissue regarding RNA examination in what is referred to as the pre-examination phase.
Note 1: Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in ISO 20184-1.
Note 2: International, national, or regional regulations or requirements can also apply to specific topics covered in ISO 20184-1.
Who is ISO 20184-1- Isolated RNA for pre-examination processes for?
ISO 20184-1 on isolated RNA for pre-examination processes is useful for:
- Medical laboratories and molecular pathology laboratories
- In vitro diagnostics developers and manufacturers
- Biobanks, institutions, and commercial organizations performing biomedical research
- Regulatory authorities
Why should you use ISO 20184-1- Isolated RNA for pre-examination processes?
Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in medicine. Further progress is expected with new technologies analyzing nucleic acids, proteins, and metabolites in human tissues and body fluids. RNA species can change differently in different donor 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.
ISO 20184-1 guideline assists you with specimen collection and transport requirements when outside the laboratory. ISO 20184‑1 provides guidance on formalin fixation of the specimen or sample, evaluation of the pathology of the specimen, selection of the sample, post-fixation of frozen samples, decalcification, processing, paraffin embedding, storage requirements, isolation of RNA, quantity, and quality assessment when inside the laboratory for frozen tissue specimens intended for examination.
This assists in the pre-examination phase to ensure the proper assessment of frozen tissue specimens intended for examination.
With compliance and obedience of ISO 20184‑1, you can produce reliable results that are comparable to other laboratories.
