BS EN ISO 20184-1:2018 pdf free.Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue Part 1: Isolated RNA.
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 workilow can influence the final analytical test result. Thus, the entire workf low 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 analytical test performance shall be performed and mitigation measures shall be established to enable the required analytical test performance.
Before or during the design of an analytical test, it should therefore be investigated and assured that the RNA profile(s) intended to be analysed is/are not compromised in a manner impacting the analytical test performance (e.g. by performing a time course experiment or study; see also Annex A).
Before tissues are stabilized by freezing, the RNA profile(s) can change e.g. by gene induction, gene down regulation and RNA degradation. These effects depend on the warm and cold ischemia duration and the ambient temperature before freezing. In addition, the described effects can vary in different donors7patients’ tissues.
Generally, the longer the duration of warm and cold ischemia and the higher the ambient temperature before freezing the tissue specimen, the higher is the risk that changes in the RNA profile can occur.
NOTE lntraoperative warm ischemia can result in more pronounced changes of RNA profiles than during postoperative cold ischemialZllUl. RNA profiles can also vary, depending on the origin and type of tissue, the underlying disease, the surgical procedure, the drug regimen, and drugs administered for anaesthesia or treatment of concomitant disease and on the different environmental conditions after the tissue removal from the body.
As warm ischemia cannot be easily standardized, its duration shall be documented. When it is not possible to avoid cold ischemia, duration shall be documented and temperatures of the specimen container’s surroundings should be documented. Where the specimen is transported to another facility for freezing, the transport duration shall be documented and the ambient conditions should also be documented.
Safety instructions on transport and handling shall be considered (see ISO 15189:2012. 5.2.3 and 5.4.5 and ISO 15190).
During the whole pre-examination process precautions shall be taken to avoid cross contamination between different specimens/samples, e.g. by using single-use material whenever feasible or appropriate cleaning procedures between processing of different specimens/samples.
If a commercial product is not used in accordance with the manufacturer’s instructions, responsibility for its use and performance lies with the user.BS EN ISO 20184-1 pdf download.
Tags: Molecular in vitro diagnostic examinations
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