BS EN ISO 20166-3:2019

What is ISO 20166-3- In- vitro diagnostic examinations on Isolated DNA about?

ISO 20166 discusses molecular in vitro diagnostic examinations.

ISO 20166-3 is the third part of a multi-part standard that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.

ISO 20166-3 assists to improve the pre-examination phase of Isolated DNA Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in medicine. However, the profiles and/or integrity of these molecules can change drastically during specimen collection, transport, storage, and processing. Therefore, it is essential to take special measures to minimize the DNA changes and modifications for subsequent examination.

Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Who is ISO 20166-3- In- vitro diagnostic examinations on Isolated DNA for?

ISO 20166-3 on in vitro diagnostic examinations for isolated DNA is useful for:

• Medical and molecular pathology laboratories
• Invitro diagnostics developers and manufacturers
• Biobanks, institutions, and commercial organizations performing biomedical research
• Regulatory authorities

Why should you use ISO 20166-3- In- vitro diagnostic examinations on Isolated DNA?

DNA integrity in tissues can change before, during, and after formalin fixation, processing, and storage. Chemical modifications introduced into DNA during tissue fixation might lead to fragmentation and sequence alterations, changes in the methylation status, or even structural changes which can lead to, for instance, spurious copy number changes in array-CGH profiles.

ISO 20166-3 guideline assists you with specimen collection and Transport requirements when outside the laboratory. And, reception of the specimen, Formalin fixation of the specimen or sample, Evaluation of the pathology of the specimen, selection of the sample, Decalcification, Storage requirements, Quantity, and quality assessment, and Storage for in vitro diagnostic examinations for isolated DNA.

This helps in proper assessment and provides reliable results for in vitro diagnostic examinations for isolated DNA that can be reproduced in any laboratory.

In addition, also assists in improving the validity and reliability of the examination test results for Isolated DNA.