Speakers
Rav Sodi
Eric Kilpatrick
Tahir Pillay
Parallel session
Chair: Rav Sodi
A key role for clinical laboratories is to provide accurate results to support and enable clinical care. It is often cited that up to 70% of all clinical decisions are predicated on pathology results. Therefore, it becomes imperative that the clinical laboratory sets quality goals that ensures that the analytical service provided is fit for the intended clinical purpose. Ever since the seminal meeting in Stockholm in 1999 when the white paper Strategies to Set Global Quality Specifications in Laboratory Medicine and then the conference held in in Milan in 2014, pathology thought leaders have discussed ways to improve the quality of laboratory tests by setting analytical performance specifications (APS). It is generally accepted that the most optimal way of doing this would be base the APS on clinical outcomes, but this is rarely practicable nor feasible. A more pragmatic approach is to use biological variation data to set APS rather than base quality goals on expert opinions whose provenance is rarely known. It is now over 10 years on since the Milan conference and whilst progress has been made in standardisation and harmonisation, there appears to be a sense in the Laboratory Medicine field that there is still uncertainty with regards to assessing the quality of biochemical assays objectively. There have been numerous national incidents in recent years where erroneous results have been issued with drastic clinical consequences. The question of how good an assay should be should resonate with all of us who are working in clinical laboratories. In this session we aim to move these discussions forward. We have key international experts who will share their views on a selection of tests and this session will provide attendees with the knowledge and skills required to set achievable quality goals in their laboratories.
Learning outcomes:
Analytical Performance Specifications (APSs) are agreed performance limits intended to inform how well a test should perform in order to meet a patient’s clinical needs. Unlike in many other countries, the use of APSs in the UK is not widespread and the limits applied are often inconsistent. However, once in place, APSs can become a cornerstone for assuring test quality. Quality control (QC) strategies designed to meet these APSs can objectively determine fundamental aspects of QC such as the control rule to use and the number/frequency of QC samples to be run. They can also help remove the subjectivity around deciding whether a poorly performing assay can continue to be used clinically or not.HbA1c measurement quality has come under scrutiny recently and provides an example of how APSs can assist in ensuring that test performance meets clinical requirements.
Learning outcomes:
Accurate assessment of low-density lipoprotein cholesterol (LDL-C) is central to cardiovascular risk stratification and decision-making for treatment, yet routine practice still relies heavily on imprecise and unstandardized direct assays and the legacy Friedewald formula. In this presentation, we review methods for LDL-C including the “gold standard” method for quantifying LDL-C and explain why this complexity has driven widespread use of calculated LDL-C, alongside the use of direct biochemical assays. We contrast the performance and limitations of the Friedewald equation with modern equations such as Martin–Hopkins, extended Martin–Hopkins and the Sampson NIH2 equation, including performance at high triglyceride levels and very low LDL-C in the era of PCSK9 inhibitors. Drawing on new data and synthetic-data simulations, we will compare the performance of contemporary equations and direct assays and outline practical recommendations for laboratories seeking best practice in assessment of LDL-C and cardiovascular risk assessment.
Learning outcomes:
Serum B12 (total B12) is the most commonly used laboratory test for the evaluation of B12 status. The clinical utility of total B12 rests largely on the application of an appropriate diagnostic cut-off for the diagnosis of B12 deficiency. NICE guidance (NG239), published in 2024, specifies a threshold of 180 ng/L (133 pmol/L) as indicative of B12 deficiency, with the caveat that local validated reference ranges may be applied as an alternative to the recommended diagnostic cut-off. This caveat is a response to the poor harmonisation of total B12 assays. In addition to poor harmonisation, audit has revealed a greater than three-fold difference (65 – 239 ng/L) in the applied diagnostic cut-off for the diagnosis of B12 deficiency across the UK, with the greatest intra-method variation seen in users of the Beckman DxI total B12 assay (65 – 180 ng/L, n= 38 laboratories). Drawing on this data, we will consider the impact of poor harmonisation of total B12 assays and unwarranted variation in applied diagnostic cut-offs for the diagnosis of vitamin B12 deficiency when using the total B12 test.
Learning outcomes:
Rav Sodi is a Consultant clinical biochemist at the Department of Clinical Biochemistry, Broomfield Hospital, Mid & South Essex NHS Trust and Honorary senior fellow at the Anglia Ruskin University, Cambridge.
He undertook undergraduate studies in Canada and postgraduate studies and specialization in Clinical Biochemistry in the UK.
He is the Director of Publications and Communications and a member of the Scientific Committee of the Association for Laboratory Medicine (UK).
He holds a number of teaching roles and has published widely in the field of Clinical Biochemistry and Laboratory Medicine and is a contributing author in the leading textbooks of the profession including the Tietz Textbook of Laboratory Medicine. He has written numerous innovative e-learning laboratory medicine education platforms including: the award-winning Learning Lab developed by the Association for Diagnostics & Laboratory Medicine (USA) and presented in the European Federation of Laboratory Medicine (EFLM) syllabus course.
His current research interests are patient-centred diagnostics particularly with applying strategies involving artificial intelligence, personalised genomics and home self-testing to improve the diagnosis and monitoring of diseases.
Eric Kilpatrick is a Consultant in Chemical Pathology at Wythenshawe Hospital in Manchester. He is also an Honorary professor of Clinical Biochemistry at Hull York Medical School and was Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine, Cornell University.
He has previously been Division chief for Clinical Biochemistry at Sidra Medicine in Doha, Qatar, and a Consultant in Chemical Pathology at both Manchester Royal Infirmary and Hull Royal Infirmary.
He is a past President of the Association for Laboratory Medicine (previously the Association for Clinical Biochemistry (ACB)) and previous Chair of the Science Committee of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).
He has a long-standing research interest in laboratory medicine and diabetes and has published over 200 papers on these and other topics.
Tahir Pillay holds several appointments as:
His past appointments includes:
He received MBChB cum laude (University of Natal), PhD in biochemistry from the University of Cambridge and a postgraduate specialist training at Hammersmith Hospital, Imperial College, London and postdoctoral training at the University of California San Diego.
Tahir is also a fellow of the Royal College of Pathologists (FRCPath).
His prior awards include the Juvenile Diabetes International Fellowship, the American Foundation of Clinical Research outstanding postdoctoral award, the Wellcome Trust Senior Clinical Fellowship, Professors Prize from the Association for Clinical Biochemistry, UK and the Senior Researcher award from the South African Association for Clinical Biochemistry.
Tahir research spans molecular cell biology of insulin signalling, the cell biology of insulin resistance, molecular modelling of ligand-receptor complexes and development of new diagnostic probes for point-of-care testing using recombinant DNA technology.
Dominic Harrington is the Chief scientific officer for SYNLAB UK and Ireland and is responsible for driving innovation, research and development in pathology services. He established the Innovation Academy in 2013 and hosts an annual Innovation Academy symposium. In 2013 he established the Future Leaders in Innovation group to provide opportunities for our leaders of the future.
Dominic’s primary research interests are in the development and application of biomarkers for the assessment of vitamin status. To support this, he coined the word ‘Nutristasis’ and established the ‘Human Nutristasis Unit’ at St. Thomas’ Hospital more than 25 years ago. The Unit now has a dedicated team of 14 scientists.
Dominic also established the international external quality assurance scheme for vitamin K (KEQAS) in 1996. His PhD was on the ‘Development of Chromatographic Methods for the Measurement of the Urinary Metabolites of Vitamin K and Their Utility for Vitamin K Status Assessment’.
Dominic has published more than 80 scientific papers and books. He has an honorary academic position at King’s College London and is a Visiting professor at the School of Biosciences and Medicine, University of Surrey.