NATIONAL MEASUREMENT LABORATORY ANNUAL REVIEW 2017 Chemical and Bio-measurement Chemical and Bio-measurement Chemical and Bio-measurement Chemical and Bio-measurement LGC AS A NATIONAL MEASUREMENT EXECUTIVE SUMMARY LABORATORY Welcome to this Annual Review of our measurement facilities that reside within the NML. National Measurement Laboratory Both programmes are run across the National LGC delivers state-of- We have two key roles: activities for 2017. Measurement System, with A4I targeted at UK the-art measurement industry and the NHS KTP allowing healthcare science in our role as a Our research areas span This year the government announced its ambitious scientists the opportunity to create, expand or National Measurement • ensuring trust and the sectors of advanced plans to boost research and development within implement innovative ideas to improve the quality of Laboratory (NML). confidence in chemical therapeutics, diagnostics, the UK, with the launch of the Industrial Strategy patient care. We value our ongoing relationships with Designated for chemical and bio-measurements safety and security and white paper, and accompanying sector initiatives our UK partner and collaborator organisations, be and bio-measurement, in the UK as identified are delivered through the and Challenge Fund (ISCF). We also saw the they industry, clinical, academic or otherwise and will we have established by government strategy four core streams of: publication of the much anticipated UK measurement work ever closer with these to ensure translation of ourselves as one of the and industry needs; strategy. These developments come at the same our measurement capability for maximum economic top measurement institutes • measurement research time as the UK prepares for exiting the EU and we and social benefit. worldwide in our field. • addressing measurement • calibration facilities have revamped components of our programmes challenges of the future • reference materials to respond to this changing landscape and to In addition, we continue to perform an important As the NML we form to foster innovation, • training and consultancy. maximise alignment and impact. This includes direct role within the international metrology community, part of the UK National promoting productivity involvement in ISCF projects, such as our £2.25m supporting global consistency and traceability Measurement System and economic growth. We play a leading role award to provide measurement infrastructure to of measurement through our activities under the (NMS), a consortium of internationally to develop support UK manufacturing of future medicines; a auspices of the International Bureau of Weights and laboratories funded by the best practice and harmonise capability that will build on our expertise in the areas Measures (BIPM), the organisation that maintains UK Government Department measurements across the of oligonucleotides, biopharmaceuticals, cell-based a coherent system of units. UK industry works in for Business, Energy world, in turn providing therapies, nanomedicines and single cell and tissue international markets and our participation in these and Industrial Strategy further confidence in imaging. activities is essential in allowing us to provide (BEIS) that provides the UK’s science and services and products that are accepted globally. the core measurement technology capabilities. This year has seen a number of successes across infrastructure for the UK. all of our areas of activity. For example, we are now I would like to thank the teams responsible for one of only a few laboratories worldwide to gain delivering our work over this year for their hard ISO/IEC 17025 accreditation for the high accuracy work and commitment to maintaining the quality and quantification of extracted DNA by digital PCR consistency of chemical and bio-measurements. Through improved chemical (dPCR), thus enabling us to support molecular and bio-measurements diagnostic companies and reference materials providers to develop products for the benefit of their we support manufacture end-users. Similarly, our nanoparticle capabilities are informing new regulatory frameworks to and trade, protect enable the safe implementation of these versatile Derek Craston consumers, and enhance materials. NML-led interlaboratory studies are Chief Scientific Officer providing best practice for direct mass spectrometry skills development analysis approaches that remove the need for sample preparation and support fields such as and quality of life. food authenticity. Finally, a novel generic approach to increase sensitivity and reduce measurement variability of routine immunoassay measurements in biological fluids has been developed and will be applied to monitor biomarkers in patients with Alzheimer’s disease. This year we have also focussed significant energy on increasing our engagement levels with measurement stakeholders. This includes the development and launch of two collaborative partnership programmes – ‘Analysis for Innovators (A4I)’ and ‘NHS England Knowledge Transfer Partnerships (KTP)’ – that provide new direct routes for stakeholders to access the unique 1 2 2 CONFIDENCE IN MEASUREMENT THE NML AND THE GLOBAL MEASUREMENT For governments, society and individuals to We work closely with government, academia COMMUNITY have confidence in the decisions that are based and private sector organisations to understand, on the thousands of routine measurements address, and manage the measurement We regularly coordinate and participate in made each day they must also have confidence challenges they face in order to provide practical international comparison studies between in the measurements themselves. and effective measurement solutions. National Measurement Institutes under the auspices of the Consultative Committee These measurements cover a vast array of for Amount of Substance: Metrology in applications, from clinicians making a medical Chemistry and Biology (CCQM), and are diagnosis, to laboratories providing forensic regarded as one of the top institutes for our evidence to support the justice system or designation within the global measurement tests to safeguard the quality of our water. community. Successful participation in these studies supports our Calibration and Measurement Capabilities (CMCs) claims which underpin our measurement services. NML stakeholder In 2017 we successfully participated in 6 distribution 2017 studies (leading on 1) spanning the full range of our capabilities. Among these were a study Industry to demonstrate competence for quantifying multiple organic analytes (amino acids), where 34% we had the best results of any participant, and Government the ongoing study to measure concentration and abundance of low level cancer mutations & regulatory in the presence of high levels of normal DNA. 25% Measurement Excellent performance at CCQM has organisations maintained the NML’s world-leading position and also led to 7 new and revised CMC claims. 1% • Inorg 033R essential elements in food and food supplements [revised] • Inorg 053 potassium in food and food supplements Other • Inorg 054 carbon isotope ratios in food and food supplements Academic 22% • Org 050 tacrolimus purity and reference 18% value (CRM/ERM-AC022) We received the first flexible broad scope claim within the organic area. 2017 achievements in numbers 2017 stakeholders in numbers → 23 peer-review publications → 480 stakeholder interactions • Org 051-053 PDBEs, PAHs, PCBs, low → 7 new CMC claims → 302 unique institutions polarity pesticides (<500Mwt), → 24 reference materials perfluorinated carboxylic acids → contributed to 22 ISO standards (<C12) and perfluorinated → 6 CCQM studies sulphonates (<C12) in soil, → 359 delegates across 14 countries trained sludge and sediment 3 CONFIDENCE IN MEASUREMENT CONFIDENCE IN MEASUREMENT 4 REFERENCE MATERIALS This year we released our Metagenomic Control Material Reference materials (RMs) are the cornerstone of accurate and traceable for Pathogen Detection (ATCC® MSA-4000™) in measurements – they are measurement standards which can be used to partnership with ATCC (American Type Culture Collection). validate analytical methods, establish traceability and support quality control. The material contains a selection of bacterial DNA species We have a portfolio of over 150 materials covering high purity standards, commonly observed in clinical infections, such as sepsis, carbon isotope ratios, food, environmental and clinical materials, and and includes organisms known to be resistant to antibiotics. alcohol standards. This year we released new materials to underpin Using our dPCR expertise, we performed quantification of therapeutic drug monitoring for transplant patients, protect food authenticity the bacterial DNA present at a range of concentrations to and safety, and support regulation around consumer products. provide customers with improved precision. This material will help researchers better understand their sequencing methods and molecular diagnostic approaches for detecting and monitoring common human diseases. New materials released in 2017: • Pure tacrolimus (ERM-AC022a) • Human blood - sirolimus (ERM-DA111a) • Electronic cigarette liquid – nicotine and water (ERM-DZ002a) In 2017, we became one of the few laboratories worldwide • Yeast - total chromium and chromium (III) (ERM-BD213a) to gain ISO/IEC 17025 calibration accreditation for purity • Peanut flour (LGCQC1020) of organic materials by quantitative NMR (qNMR). Replacement materials released in 2017: Our current