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Aberdeen, United Kingdom

Viljoen A.,Clinical Biochemistry
International Journal of Clinical Practice | Year: 2013

The current lack of sufficient evidence of vitamin D's role in CVD calls for perspective and caution to avoid that health claims, vitamin D testing and supplementations' sales will continue to run well ahead of the scientific evidence. © 2013 John Wiley & Sons Ltd.

Viswanathan K.,Yorkshire Heart Center | Hall A.S.,Yorkshire Heart Center | Barth J.H.,Clinical Biochemistry
Clinical Biochemist Reviews | Year: 2012

Cardiac troponins have been the biomarkers of choice for the diagnosis of acute coronary syndrome (ACS) for over a decade. There has, however, been considerable interest over the last two decades for newer biomarkers that would bring added value to the measurement of troponin such as the provision of prognosis and assistance in the choice of therapeutic interventions. In this manuscript, we review the development of heart-type fatty acid binding protein (H-FABP) in patients with ACS using the evidence-based laboratory medicine format. Phase I studies have established that H-FABP reference intervals and pre-analytical factors influencing H-FABP. Phase II studies have confirmed a) that H-FABP is elevated in patients with established myocardial infarction; b) that its serum concentration is related to the extent of infarction using survival as a surrogate; and c) that its use in chest pain patients can identify ACS patients and also provide prognostic information on survival. Furthermore, it is an independent prognostic marker for patients with suspected ACS who are troponin negative. Phase III studies involving randomised control trials for diagnosis and prognosis have not yet been performed and Phase IV studies await uptake of H-FABP in a routine service.

Barth J.H.,Clinical Biochemistry
Annals of Clinical Biochemistry | Year: 2012

Clinical laboratories have an important role in improving patient care. The past decades have seen enormous changes with unpredictable improvements in analytical performance, range of tests and capacity to manage large volumes of work. At the same time, there has been a dramatic fall in the rate of laboratory errors. However, there is now a growing awareness that the testing process includes the time before samples reach the laboratory and after reports have been printed and that these areas need to be included in the quality assessment of the total testing process. Laboratory quality should include a focus on patient safety and clinical effectiveness. Services should be patient-centred, timely, efficient and equitable, and finally, should be moulded to ensure optimal outcomes. There is a need to define quality indicators that will ensure there is appropriate choice and selection of tests, use of the appropriate assay standardization and the correct interpretation of the assay results at the appropriate time. These are the areas in which a quality laboratory can, and should, now involve itself.

Fenger M.,Clinical Biochemistry
Frontiers in Genetics | Year: 2014

One of the goals in genetic research aims at identifying genes in biochemical and physiological processes to reveal genetic causes of rare and common diseases. Previous obstacles such as costly genotyping or sequencing have been reduced with the chip-based genomewide association studies (GWAS), now culminating with the latest toy-next generation sequencing methodologies (NGS). Concomitantly, computer technologies have evolved to an increasing use of multicore processors and distributed computing on large networks or grids. Although the technologies are not perfect, we now have unprecedented opportunities to perform genetic studies not possible just 10 years ago. The hype about these new technologies have been large, but all the promises have however not been fulfilled entirely as hoped for. Maybe because the hype has been more about the technologies as such, and less about their intended use. Millions of genetic variations have been detected by GWAS and NGS, but only a few have been linked to diseases-with almost no practical clinical significance. A major reason for this apparent deadlock is the inadequacy of the models used, which are based on the traditional "Mendelian" approach, in which one gene is supposed to have a main effect on a trait or a disease. However, most genes claimed to be associated with a disease have small effects and only a tiny fraction of the genetic variance has been captured. © 2014 Fenger.

Misra S.,Imperial College London | Barth J.H.,Clinical Biochemistry
Clinica Chimica Acta | Year: 2014

Clinical guidelines are ubiquitous, manifold and form an integral component of evidence-based clinical practice. Guidelines on test selection are often considered a useful adjunct to aid clinical decision-making, as test selection is a complex process that is influenced by many patient, clinician and laboratory factors. However, it is important to carefully evaluate several aspects of these guidelines, which include the context of the test in the guideline, the quality of the studies underpinning recommendations, the extent of the evaluation of effectiveness (or performance) of the specific test and in the clinical pathway, its applicability and ease of implementation. A robust evaluation of a diagnostic test should incorporate several stages including evaluation in healthy, symptomatic but unaffected and affected populations, and importantly a measurement of impact on patient outcomes. Few diagnostic studies meet these criteria, and therefore crucial aspects of test evaluation are overlooked prior to incorporation into clinical guidelines. Whilst efforts are made to standardise reporting of studies, strength of evidence and quality of guidelines, further work is required to improve the quality of the diagnostic studies that formulate these guidelines. It is important that clinicians using guidelines for test selection appreciate the limitations of the diagnostic test, and the guidelines themselves. © 2014 Elsevier B.V.

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