ISO 20184-2:2018 pdf download.Molecular in vitro diagnostic examinations Specifications for pre-examination processes for frozen tissue Part 2: Isolated proteins.
ISO 20184-2 gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-exarnination phase before a molecular assay is performed.
ISO 20184-2 is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of ISO 20184-2. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 15189:2012, Medical laboratories — Requirements for quality and competence
primary sample specimen
discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or more quantities or properties assumed to apply for the whole
[SOURCE: ISO 15189:2012, 3.16, modified — The term and definition is used here without the original notes.J
3.12
protein
type of biological macromolecules composed of one or more chains with a defined sequence of amino acids connected through peptide bonds
3.13
protein profile
amounts of the individual protein molecules that are present in a sample and that can be measured in the absence of any losses, inhibition and interference
For general statements on medical laboratory quality management systems and in particular on specimen collection, reception, and handling (including avoidance of cross contaminations) see ISO 15189:2012, 4.2, 5.4.4, 5.4.6, or ISO/IEC 17020:2012, Clause 8 and 7.2. The requirements on laboratory equipment, reagents, and consumables in accordance with ISO 15189:2012, 5.3 shall be followed; ISO 15189:2012, 5.5.1.2 and 5.5.1.3, and ISO/IEC 17020:2012, 6.2 can also apply.
All steps of a diagnostic workflow can influence the final analytical test result. Thus, the entire workflow including biomolecule stability and sample storage conditions shall be verified and validated. Workflow steps which cannot always be controlled (e.g. warm ischemia) shall be documented. A risk assessment of non-controllable workflow steps including their potential impact on the examination test performance shall be performed and mitigation measures shall be established to enable the required examination test performance.
The stability of the specific proteins to be examined and their posttranslational modifications (if important for the assay) should be investigated throughout the complete pre-examination process prior to the development and implementation of an examination test (e.g. by performing a time course experiment or study; see also Annex A and Reference ).ISO-20184-2-2018