The central role of external quality assurance in harmonisation and standardisation for laboratory medicine

Greaves, Ronda F.

doi:10.1515/cclm-2016-0782

Cited by 16 publications

(5 citation statements)

References 4 publications

(5 reference statements)

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“…This finding was expected, given the high variability in the IAs results in steroid determination. 18 Therefore, the introduction of new EPs into routine clinical medicine calls for a revision of reference intervals, while taking into account the procedure reported in the CLSI EP28-A3C-ED3, 19 in particular the section dedicated to the transference of the reference intervals. The reference intervals already in use could be re-calculated using the Passing–Bablok regression obtained or the reference interval established by the manufacturer could be used.…”

Section: Discussionmentioning

confidence: 99%

The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

et al. 2019

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Background In a medical laboratory, changes may be made to the analytical phase of diagnostic testing whenever a new test or the issue of a ‘new generation’ kit or new diagnostic system is required. In such cases, ISO 15189:2012 accreditation can assist laboratory professionals. The aim of the present study was to propose a working pathway for introducing new examination procedures into clinical practice in accordance with the ISO 15189:2012 standard, through the exemplars of 17-hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D. Methods The working pathway includes the following steps: (i) analysing examination procedures under evaluation, (ii) analysing examination procedures currently in use, (iii) verifying metrological traceability, (iv) verifying examination procedures and (v) evaluating comparability of results. Results The analysis of instructions for use issued by manufacturers revealed that metrological traceability was reported only for vitamin D. The imprecision verification was satisfactory, the imprecision obtained by the laboratory in terms of total imprecision always being less than the specified total imprecision. In only one case (IQC level 1, 17-hydroxy progesterone), the total upper verification limit was calculated. The trueness verification was satisfactory for all examination procedures, except for 17-hydroxy progesterone (second material). Passing–Bablok regression analyses in the comparability study demonstrated significant differences for all the examination procedures. Conclusions The working pathway described for examination procedures in routine practice is in accordance with the requirements of ISO 15189:2012 accreditation and takes feasibility into account (as its main goal), based on the cost/patient benefit ratio.

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Section: Discussionmentioning

confidence: 99%

The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

et al. 2019

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“…Steroid metabolites identified in serum and urines are shown in light gray boxes and dark gray boxes, respectively. From Greaves et al [31].…”

Section: The Physiology Of Dheamentioning

confidence: 99%

Dehydroepiandrosterone (DHEA) and DHEA Sulfate: Roles in Brain Function and Disease

Quinn¹,

Robinson²,

Walker³

2018

Sex Hormones in Neurodegenerative Processes and Diseases

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Among the neuroactive steroids, dehydroepiandrosterone (3b-hydroxyandrost-5-ene-17-one, [DHEA]) and its sulfated metabolite DHEA sulfate (DHEAS) have been shown to be potent modulators of neural function, including neurogenesis, neuronal growth and differentiation, and neuroprotection. Highlighting the potential health significance of DHEA and DHEAS in humans, serum concentrations decrease steadily with age, with lowest concentrations present at the time many diseases of aging and neurodegeneration become apparent. This temporal association has led to the suggestion that pathology associated with cognitive decline, age-related neurological disorders such as Alzheimer's disease, dementia, amyotrophic lateral sclerosis (ALS), and adult onset schizophrenia may, in part at least, be attributed to decreased secretion of DHEA. Animal studies suggest neuroprotective functions for DHEA and DHEAS through reduction of glutamate-induced excitotoxicity. Reduced myelin loss and reactive gliosis after spinal cord injury by DHEA treatment also suggest a role for DHEA in the treatment of white matter pathologies such as multiple sclerosis. In this chapter, we discuss the physiological roles of DHEA and DHEAS in the central nervous system (CNS), their potential as neuroprotective hormones with reference to documented effects on excitotoxicity and oxidative stress, and their anti-glucocorticoid actions during chronic stress. The potential for metabolic derivatives of DHEA, such as estrogens and testosterone on brain function, and their contribution to neurodevelopment and neurodegenerative conditions are also discussed.

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“…With both harmonization and standardization, external quality assurance programs play a central role in supporting agreement (43). DSD are rare conditions, so international collaboration is necessary to improve diagnostics and treatment follow-up of these conditions, and therefore agreement in laboratory medicine is crucial.…”

Section: Harmonization Of Laboratory Testsmentioning

confidence: 99%

Peptide hormone analysis in diagnosis and treatment of Differences of Sex Development: joint position paper of EU COST Action ‘DSDnet’ and European Reference Network on Rare Endocrine Conditions

Johannsen

Andersson

Ahmed

et al. 2020

European Journal of Endocrinology

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Differences of Sex Development (DSD) comprise a variety of congenital conditions characterized by atypical chromosomal, gonadal, or anatomical sex. Diagnosis and monitoring of treatment of patients suspected of DSD conditions include clinical examination, measurement of peptide and steroid hormones, and genetic analysis. This position paper on peptide hormone analyses in the diagnosis and control of patients with DSD was jointly prepared by specialists in the field of DSD and/or peptide hormone analysis from the European Cooperation in Science and Technology (COST) Action DSDnet (BM1303) and the European Reference Network on rare Endocrine Conditions (Endo-ERN). The goal of this position paper on peptide hormone analysis was to establish laboratory guidelines that may contribute to improve optimal diagnosis and treatment control of DSD. The essential peptide hormones used in the management of patients with DSD conditions are follicle-stimulating hormone, luteinising hormone, anti-Müllerian hormone, and Inhibin B. In this context, the following position statements have been proposed: serum and plasma are the preferred matrices; the peptide hormones can all be measured by immunoassay, while use of LC-MS/MS technology has yet to be implemented in a diagnostic setting; sex- and age-related reference values are mandatory in the evaluation of these hormones; and except for Inhibin B, external quality assurance programs are widely available.

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The central role of external quality assurance in harmonisation and standardisation for laboratory medicine

Cited by 16 publications

References 4 publications

The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

Dehydroepiandrosterone (DHEA) and DHEA Sulfate: Roles in Brain Function and Disease

Peptide hormone analysis in diagnosis and treatment of Differences of Sex Development: joint position paper of EU COST Action ‘DSDnet’ and European Reference Network on Rare Endocrine Conditions

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