What is ISO 20186-1- Pre-examination processes for venous whole blood about?
ISO 20186 discusses molecular in vitro diagnostic examinations.
ISO 20186-1 is the first part of a multi-part series that lays out guidelines on the handling, storage, processing, and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. ISO 20186-1 covers specimens collected in venous whole blood collection tubes.
ISO 20186-1 helps you to standardize the entire workflow from specimen collection to the cellular RNA examination and helps you to determine important influencing factors.
Note 1: Different dedicated measures are taken for stabilizing blood cell-free circulating RNA and RNA in exosomes circulating in the blood. These are not described in ISO 20186-1.
Note 2: Different dedicated measures are taken for collecting, stabilizing, transporting, and storing capillary blood as well as for collecting and storing blood by paper-based technologies or other technologies generating dried blood. These are not described in ISO 20186-1.
Note 3: ISO 20186-1 does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom.
Note 4: RNA in pathogens present in the blood is not covered by ISO 20186-1.
Who is ISO 20186-1- Pre-examination processes for venous whole blood for?
ISO 20186-1 on pre-examination processes for venous whole blood are useful for:
- Medical laboratories
- In vitro diagnostics developers and manufacturers performing biomedical research
- Biobanks, institutions, and commercial organizations performing biomedical research
- Regulatory authorities
Why should you use ISO 20186-1 - Pre-examination processes for venous whole blood?
Blood cellular RNA profiles can change significantly after blood collection. Therefore, special measures need to be taken to secure good quality blood samples for cellular RNA examination and storage.
ISO 20186-1 guideline assists you with Specimen collection and Transport requirements when outside the laboratory. In addition, Specimen reception, Storage requirements, Isolation of the cellular RNA, Storage of isolated cellular RNA, Quantity, and quality assessment of isolated cellular RNA when inside the laboratories.
This helps in proper assessments and provides reliable results for molecular In vitro diagnostic examinations for isolated cellular RNA that are reproducible in any laboratory.
