What is ISO 20186-2-Isolated genomic DNA for molecular in vitro diagnostic examinations about?
ISO 20186 discusses specifications for pre-examination processes in molecular in vitro diagnostic examinations. ISO 20186-2 is an international standard that provides for isolated genomic DNA for pre-examination processes in molecular in vitro diagnostic examinations.
ISO 20186-2 is the second part of a multi-part series that specifies guidelines on the handling, storage, processing, and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. ISO 20186-2 covers specimens collected in venous whole blood collection tubes.
Note 1: Different dedicated measures are taken for stabilizing blood cell-free circulating DNA that is not measured under ISO 20186-2.
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 is not included under ISO 20186-2.
Note 3: ISO 20186-2 does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom and DNA in pathogens present in the blood.
Who is ISO 20186-2- Isolated genomic DNA for molecular in vitro diagnostic examinations for?
ISO 20186-2 on isolated genomic DNA for molecular in vitro diagnostic examinations is relevant to:-
- Medical laboratories
- Manufacturers related to Molecular in vitro diagnostic
- Vitro diagnostics developers
- Institutions and commercial organizations performing biomedical research
- Medical regulatory authorities
Why should you use ISO 20186-2- Isolated genomic DNA for molecular in vitro diagnostic examinations?
Molecular in vitro diagnostics has enabled significant progress in medicine. Further progress is expected by new technologies analyzing profiles of nucleic acids, proteins, and metabolites in human tissues and body fluids. However, the profiles of these molecules can change drastically during the pre-examination process, including specimen collection, transport, storage, and processing. Consequently, this makes the outcome from diagnostics or research unreliable or even impossible, because the subsequent examination might not determine the real situation in the patient, but an artificial profile generated during the pre-examination processes.
ISO 20186-2 draws upon such work to codify and standardize the steps for venous whole blood genomic DNA examination in what is referred to as the pre-examination phase.
By adopting ISO 20186-2 the user can standardize the entire workflow from specimen collection to the genomic DNA examination.
