What is ISO 20186‑3 - Molecular in-vitro diagnostic examinations about?
ISO 20186 discusses molecular in-vitro diagnostic examinations. ISO 20186‑3 layouts recommendations and requirements on the handling, storage, processing, and documentation of venous whole blood specimens intended for circulating cell-free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. ISO 20186‑3 covers specimens collected in venous whole blood collection tubes.
ISO 20186‑3 helps in taking special measures to secure good quality specimens for ccfDNA examination.
Note 1: Different dedicated measures are taken for stabilizing blood genomic DNA, which is not described in this document. Blood genomic DNA is covered in ISO 20186-2. Different dedicated measures are taken for preserving DNA in circulating exosomes, which are not described in ISO 20186‑3.
Note 2: The ccfDNA obtained from blood by the procedures cited in ISO 20186‑3 can contain DNA originally present in exosomes.
Note 3: DNA in pathogens present in the blood is not covered by ISO 20186‑3.
Who is ISO 20186‑3 - Molecular in-vitro diagnostic examinations for?
ISO 20186‑3 on isolated circulating cell-free DNA from plasma is useful for:
- Diagnostic centers and medical laboratories
- In vitro diagnostics developers and manufacturers
- Biobanks, institutions, and commercial organizations performing biomedical research
- Regulatory authorities
Why should you use ISO 20186‑3 - Molecular in-vitro diagnostic examinations?
Molecular in vitro diagnostics has enabled significant progress in medicine. Circulating cell-free DNA profile is the amount of different ccfDNA molecules, present in blood and plasma that can be measured in the absence of any losses, inhibition, and interference.
ISO 20186‑3 best practice guideline helps you with specimen collection and transport requirements when outside the laboratory. ISO 20186‑3 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 protein, quantity, and quality assessment when inside the laboratory for venous whole blood specimens intended for circulating cell-free DNA (ccfDNA) examination.
This helps the pre-examination phase that helps in the proper assessment of venous whole blood specimens intended for circulating cell-free DNA (ccfDNA) examination. ISO 20184‑2 provides reliable results that are comparable to other laboratories.