European Standards have a fundamental role in providing safe access to healthcare for patients by setting safety, quality and performance requirements for medical devices. In this context, an important part of ensuring high levels of healthcare and prevention derives from making sure that diagnoses are correct and timely.
To minimise the risk of non-objective diagnoses and increase safety, CEN recently published the series of standards EN 20166:2018 ‘Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue’. Within its three parts on isolated RNA, isolated proteins and isolated DNA, this series covers the processes of analysis preparation, starting from sample collection to handling, documentation, storage and processing of specimens to the isolation of various substances.
The standards included in the 20166 series are specifically designed for molecular in vitro diagnostic examinations, including laboratory tests, performed by medical laboratories and molecular pathology laboratories. They are also applicable to other stakeholders, such as in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial performing biomedical research and regulatory authorities.
The objective of this standard series is to reduce the impact of external factors on the results of examinations, thus ensuring that patients obtain diagnoses that are as objective as possible. Indeed, in research there is clear scientific evidence that several factors of the pre-examination phase influence the outcome of in situ detection and, thus, can have major impact on the diagnostic results. Since the reliability of analytical results in examinations is markedly dependent on the proper processing of the biospecimen during the pre-examination phase, a high level of standardization of the procedures of the pre-examination phase is required.
The EN ISO series 20166:2018 was developed in the framework of the SPIDIA project, a 4.5-year project funded by the European Union. Project partners, as well as representatives from a wider community of manufacturers, European and international research associations, users and researchers provided input on the content of the specifications. Its successor, the 48-month-project SPIDIA4P (Standardization of generic Pre-analytical Procedures for In vitro DIAgnostics for Personalised Medicine), is taking up the work on standardization and improvement of pre-analytical procedures for in vitro diagnostics.
The standard series was developed by CEN/TC 140 ‘In vitro diagnostic medical devices’, in close contact with ISO/TC 212 ‘Clinical laboratory testing and in vitro diagnostic test systems’. The Secretariat of CEN/TC 140 is held by DIN, Germany’s National Standardization Body, who is one of the partners of the SPIDIA and SPIDIA4P projects.
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