BS EN ISO 20166-1:2018

What is ISO 20166‑1- Isolated RNA for pre-examination processes about?  

ISO 20166 is an international standard that discusses molecular in vitro diagnostic examinations. ISO 20166‑1 provides the best industry guidance on Isolated RNA examination during the pre-examination phase to produce reliable results that are comparable to other laboratories. 

ISO 20166‑1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. 

ISO 20166‑1 assist in codifying and standardizing the steps for formalin-fixed and paraffin-embedded (FFPE) tissue about isolated RNA examination during the pre-examination phase. 

Note 1: International, national, or regional regulations or requirements can also apply to specific topics covered in ISO 20166‑1. 

Who is ISO 20166‑1- Isolated RNA for pre-examination processes for? 

ISO 20166‑1 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 20166‑1- 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 profiles in tissues can change drastically before, during, and after collection and change differently in different donors '/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 20166‑1 guideline assists you with specimen collection and transport requirements when outside the laboratory. ISO 20166‑1 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 formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for isolated RNA examination during the pre-examination phase. 

With compliance and obedience to ISO 20166‑1, you can assess the formalin-fixed and paraffin-embedded (FFPE) tissue specimens efficiently that are intended for examination of isolated RNA to provide reliable results that are comparable to other laboratories.