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Standards Development
This document provides an overview of measurement procedures for biological sample analysis using electron microscopy. This is exemplified by synthetic nanoscale biological materials that have undergone a series of inter-laboratory comparisons and is offered as the first metrologically traceable biological reference material for the characterisation of biological and patient biopsy specimen using electron microscopy. An emphasis is also made on the use of the materials of this type for the internal calibration, calibration assessment and performance optimization of electron microscopes for biological sample imaging and analysis.
The ultrastructural analysis and validation of biological materials with a nanoscale precision is of particular importance and may be accomplished by high-resolution microscopy measurements. However, modern microscopes continue using in-built magnification scales for routine calibrations, whereas advances in technology development and a clear shift towards more automated systems challenge the accuracy of such scales for quantitative measurements in biological and clinical applications. In addition, demand for traceability, which accompanies improved technologies, is driving the need for assessing instrument performance from the scale of optical and super-resolution imaging to high-resolution and cryo-electron microscopes. An immediate goal here is to provide reference materials with nanoscale periodicities repeated over microscopic length scales with controlled dimensions and large aspect ratio. Bespoke designer nanostructures assembled from geometrically consistent polypeptide building blocks can qualify as internal calibration standards for the reproducible analysis of biological and soft matter and for the optimization of microscope performance and the calibration of instruments. Qualitative analyses at the nanoscale becomes ever more important across many industries including but not limited to pharma and medical devices (including veterinary), transport (aviation, land-based and marine), energy infrastructure, environmental protection, food, fast moving consumer good, electronics and microscope manufacturing companies. An ability to construct biological matter from the molecule upholds promise for industry applications ranging from smart nanostructured materials to bio parts for synthetic biology. Biomolecular self-assembly is the strategy of choice for material construction as it can be programmed to enable a specific function. Perfected in biology self-assembling systems have impacted on nearly every conceivable nanomaterial type to date. However, with all the success and information available to us, commercialization of nanostructured biological materials is hampered by the lack of biologically relevant reference materials and validation measurement procedures that can benchmark the performance of emerging technologies. The material was either tested or characterized and the protocols to use the biological reference material were validated in an inter-laboratory comparison with the participation of experts in high-resolution and highcontrast electron microscopy in total of 30 laboratories across the world. The laboratories are actively involved in the characterization of biological specimens and materials at the nanoscale, electron microscopes manufacturing, standarisation, instrument development, metrology, government and healthcare laboratory services. This Technical Specifications can contribute to the establishment and development of an international standard for the validation and application of synthetic biological reference materials for the ultrastructural analysis of biological and soft matter specimen including the implementation of the materials for routine diagnostic practices in national healthcare systems. The document will provide guidance to inter-laboratory comparisons for candidate reference materials and their application to validate commercial products thereby supporting the advancement of industries relying on the use of nanomaterials and to significantly improve existing procedures of differential- and virus diagnostics in hospitals and in support of vaccine development using electron microscopy.
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