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Iron deficiency anemia is a significant global health concern, diagnosed by measuring hemoglobin concentrations in combination with plasma ferritin concentration. This study investigated the variability in ferritin reference intervals among laboratories in the Netherlands and examined how this affects the identification of iron-related disorders.Ferritin reference intervals from 52 Dutch ISO15189-certified medical laboratories were collected. Ferritin, hemoglobin and mean corpuscular volume data of non-anemic apparently healthy primary care patients, measured by four laboratory platforms (Beckman, Abbott, Siemens, and Roche), were collected (n=397,548). Median ferritin levels were determined per platform, stratified by sex and age. The proportion of ferritin measurements outside of the reference interval was calculated using the reference intervals from the 52 laboratories (using a total of n=1,093,442 ferritin measurements). Lastly, ferritin data from 3,699 patients as captured in general practitioner (GP) data from the PHARMO Data Network were used to assess the variation of abnormal ferritin measurements per GP.Median plasma ferritin concentrations were approximately four times higher in men and twice as high in postmenopausal women compared to premenopausal women. Moreover, there are substantial differences in the median plasma ferritin concentration between the four platforms. However, even among laboratories using the same platform, ferritin reference intervals differ widely. This leads to significant differences in the percentages of measurements classified as abnormal, with the percentage of ferritin measurements below the reference limit in premenopausal women ranging from 11 to 53 %, in postmenopausal women from 3 to 37 %, and in men from 2 to 19 %. The percentage of ferritin measurements above the reference limit in premenopausal women ranged from 0.2 to 11 %, in postmenopausal women from 3 to 36 % and in men from 7 to 32 %.The lack of harmonization in ferritin measurement and the disagreement in plasma ferritin reference intervals significantly impact the interpretation of the iron status of patients and thereby the number of iron disorder diagnoses made. Standardization or harmonization of the ferritin assays and establishing uniform reference intervals and medical decision limits are essential to reduce the substantial variability in clinical interpretations of ferritin results. [ABSTRACT FROM AUTHOR]

Thyroid-stimulating hormone (TSH) is an important clinical marker in the diagnosis and management of thyroid disease. TSH measurements are reported in milli-International Units per Litre (mIU/L), traceable to a World Health Organisation (WHO) reference material. There is a wide variety of commercial immunoassays for TSH measurements available, which have historically been poorly harmonised due to a lack of commutability of the WHO reference materials with patient samples. This led to the recent development of a serum-based reference panel for TSH, traceable to the WHO reference material, available via the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC), aimed at harmonisation of TSH immunoassays. This report describes recent developments in the TSH reference system, including establishment of the 4th WHO International Standard for TSH, and aims to clarify the relationship between the available reference materials and their intended uses. This 4th WHO IS is widely available and defines the unit of TSH activity, therefore its continued existence is of paramount importance, however it continues to show a lack of commutability with patient in many TSH immunoassays. This makes the C-STFT TSH panel, albeit available in restricted numbers, a critical resource to ensure better TSH assay harmonisation. [ABSTRACT FROM AUTHOR]

This paper presents a case study based on the writing of James Horner, one of the many Irish emigrants who crossed the Atlantic between the late 1700s and early 1800s. Communication between Horner and his family back in Ireland was kept through personal correspondence. His letters, which contain about 14,000 words in total, are part of the Corpus of Irish English Correspondence (CORIECOR), and they provide detailed accounts of his experiences and impressions of the recently adopted country. They also show progressive standardisation, which makes them an interesting site for historical sociolinguistic analysis: shifting from vernacular Irish English towards a more standardised type of English to some degree. Our study focuses on the use of subject-verb agreement and addresses the following research questions: does geographical and social mobility condition Horner's speech? If so, how does an individual's social status affect language? The findings reported below show that social mobility as well as dialect contact seem to have contributed to general standardisation and the subsequent blurring of identity markers in language use. The paper, thus, offers new perspectives on the analysis of intra-speaker variation using historical data and contributes to the discussion of the need for this type of micro-analysis in the area of historical sociolinguistics. [ABSTRACT FROM AUTHOR]

The letter responds to an article evaluating the performance of the DiaSys PCT assay for procalcitonin testing. The authors note that the DiaSys PCT assay showed good analytical performance and agreement with other licensed methods at higher concentrations, but had poor agreement and higher imprecision at lower concentrations. They also discuss the limitations of the study, including different protocols used for evaluation and the lack of information about PCT concentrations. The authors highlight the advantages of the PETIA technology used in the DiaSys assay, such as faster results and lower costs, particularly in low or middle-income countries. They emphasize the need for standardization and an international reference material for procalcitonin assays. [Extracted from the article]

British Sign Language (BSL) has been shown to have a high degree of regional variation especially at the lexical level. This study explores awareness and attitudes of the British deaf community towards this regional variation. We studied interview data from the BSL Corpus (http://bslcorpusproject.org/data) from 121 deaf, BSL signers from six regions across the UK including Belfast, Birmingham, Bristol, Glasgow, London and Manchester, focusing on responses to five questions in relation to regional variation in BSL. Responses were analysed using thematic analysis, following (Braun, V. & V. Clark. 2006. Using thematic analysis in psychology. Qualitative Research in Psychology 3(2). 77–101. https://doi.org/10.1191/1478088706qp063oa). Findings reveal that BSL signers exhibited overall high levels of meta-linguistic awareness, as many of their attitudes and beliefs were in line with what has been reported in relation to linguistic behaviour with BSL such as mouthing, fingerspelling and accommodation. In addition, BSL signers seem to place enormous value on regional variation in BSL, believing that such variation contributes to the richness of BSL as a language and puts it on equal footing with the surrounding majority language, i.e. English. We explore the implications of these attitudes towards a broader understanding of language ideologies, including the concept of accent. [ABSTRACT FROM AUTHOR]

Parathyroid hormone (PTH) determination is of paramount importance for the exploration of diseases related with calcium metabolism and for the follow-up of patients suffering from bone and mineral disorders associated with chronic kidney diseases (CKD-MBD). Unfortunately, the biologically active form of PTH, i.e. 1–84 PTH, circulates in the blood stream with many fragments and post-translationally modified forms, which decreases the specificity of immunoassays. The assays used to measure PTH, either from 2nd or 3rd generation, are not standardised, which may lead to interpretation errors and clinical consequences. Reference ranges for PTH have neither been always correctly established and the stability of the peptide is also a matter of concern. Fortunately, these last years, newer techniques using mass spectrometry (either high resolution or triple quadripole) coupled with liquid chromatography have been developed, which will help to standardise the different assays. Indeed, PTH assays standardisation is one of the task of the IFCC Committee for Bone Metabolism. Such standardisation will allow a better consistency in the interpretation of the results and will promote studies aiming at the establishment of correct reference ranges. [ABSTRACT FROM AUTHOR]

Keywords: JCTLM; laboratory medicine; reference measurement procedure; standardisation; traceability EN JCTLM laboratory medicine reference measurement procedure standardisation traceability 1887 1889 3 10/03/23 20231001 NES 231001 Standardisation is the pinnacle of analytical measurement in laboratory medicine, facilitating comparability of patient results over time. An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of aldosterone in human serum and plasma. An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS)-based candidate reference measurement procedure (RMP) for the quantification of methotrexate in human serum and plasma. [Extracted from the article]

Safe implementation and thorough evaluation of new treatments require prospective data monitoring and standardization of treatments. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a promising alternative for the treatment of patients with peritoneal disease with an increasing number of suggested drug regimens. The aim was to reach expert consensus on current PIPAC treatment protocols and to define the most important research topics.

To assess interlaboratory variability of total serum bilirubin (TSB) results in newborns. Initiated following a clinical incident in which a neonate was transferred to a tertiary hospital for treatment of severe hyperbilirubinemia but on arrival was reclassified into a lower risk category due to a 20% difference in TSB between laboratories. Fresh residual plasma samples from hospital-born infants were pooled to obtain 11 samples across a range of total bilirubin concentrations. Aliquots were light-protected and measured on 7 commercial platforms at 4 accredited medical laboratories. Data from The Royal College of Pathologists of Australasia Quality Assurance Programs' (RCPAQAP) Neonatal Bilirubin program was analysed. Twenty-four to 30% difference in results for individual samples, largely due to calibration differences between assays. When interpreted according to guidelines, results from different platforms would have led to different clinical interventions in some cases. RCPAQAP results showed significant within-method bias but were not shown to be commutable with patient samples. There are clinically significant method-dependent differences in TSB results from neonatal samples, consistent with our clinical incident. The differences are largely due to lack of standardisation of calibrator values. This has implications for healthcare resource use and possibly for the neurodevelopment of infants. Intervention is needed at a number of levels, including clinical reporting of incidents arising from discordant results, commitment by manufacturers to ensure metrological traceability of methods with sufficiently low uncertainty in the final measurements, and availability of commutable quality assurance material to monitor assay performance, especially at the clinical decision points for neonatal jaundice. [ABSTRACT FROM AUTHOR]

During the sixteenth and the seventeenth centuries, a number of spelling solutions gradually became established in English as ways to indicate vowel quality, namely whether a vowel sound was different from another, and vowel quantity, that is to say whether a vowel was long or short. Among the solutions that arose to indicate vowel quality, and were introduced for spellings like sea and boat. For vowel quantity, 'single' consonants in pairs like and , and , as well as and began to be used for immediately preceding long vowels. My contribution explores all of the examples of vowel diacritic spelling mentioned above in printed English between 1500 and 1700, using a quantitative model for the analysis of patterns across a range of texts from Early English Books Online. The analysis shows an overall process of standardisation occurring between the sixteenth and the seventeenth centuries, and provides fresh insights into the lexical distribution for the standardisation of vowel diacritic spelling. The discussion reflects upon the development of the spellings, and argues for pragmatic factors within the Early Modern English printing industry as responsible for their modern standardisation. [ABSTRACT FROM AUTHOR]

In vitro wound healing assays are a suitable application to verify the efficiency of pharmaceuticals or growth factors that will be incorporated in or immobilized to e.g. electrospun biomaterials for wound dressings or other biological devices in advance. Thereby, various factors like culture conditions or cell density influence the specific cell proliferation. Hence, to establish a wound healing assay for various cell types, a stepwise adaptation of cell numbers was done for better estimation and comparison of cell density for the validation of the influence of drugs on the wound healing process. Cell proliferation of different tissue relevant cell types was evaluated by impedance measurements and live cell imaging. Cell numbers could be successfully adapted for assay specific cell densities. In general, a universal comparison of biological or chemical materials and agents in vitro may require the creation of appropriate ISO or OECD standards for a consistent and cell specific adaptation or demand of initial cell density.

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In Cabo Verde, Portuguese is the official language, while Kriolu is the first language of virtually all the population. The schooling context clearly reflects this diglossic situation: while the vast majority of children speak Kriolu at home, Portuguese continues to be the exclusive language of instruction. Thus, Portuguese in Cabo Verde represents a post-colonial language that has maintained its de jure status but has not entered de facto domains of use. The research described in this article is based on discourse analysis of legislative and policy documents and extended semi-structured interviews with politicians, educators and language activists. Our results in this former colonial context invite us to reconsider traditional understandings of pluricentricity, as they suggest that Cabo Verdean Portuguese is not (yet) associated with local identity and has not (yet) been accepted by its speakers as a legitimate, standardised variety. [ABSTRACT FROM AUTHOR]

Against the background of a concise overview of Ulrich Ammon's oeuvre this article first of all provides a constructive-critical account of some of the key concepts and questions that guided his macrosociolinguistic work on pluricentric languages and variation in German. In what follows, an attempt is made to further develop some of Ammon's thoughts through emphasising the elasticity of the concept of pluricentricity and arguing for a creative use of the concept of "roofing" when describing the intricate interplay of standard and nonstandard varieties especially in language contact zones. [ABSTRACT FROM AUTHOR]

Biomedicines are complex biochemical formulations with multiple components that require extensive quality control during manufacturing and in subsequent batch testing. A proof-of-concept study has shown that an application of Raman spectroscopy can be beneficial for a classification of vaccines. However, the complexity of biomedicines introduces new challenges to spectroscopic methodology that require advanced experimental protocols. We further show the impact of analytical protocols on vaccine classification using R as an Open Source data analysis platform. In conclusion, we advocate for standardized and transparent experimental and analytical procedures and discuss current findings and open challenges. [ABSTRACT FROM AUTHOR]

Background: Total haemoglobin (Hb) concentration in blood belongs to the most requested measurands, and the HiCN method (hemiglobincyanide) is accepted as a reference. Although the reaction principle is clearly characterised, measurement conditions and settings are not consistently defined, some of them influencing the results. An improvement of standardisation is the object. Methods: After method optimization, measurement results between different calibration laboratories (CL) were compared with each other and also with results of the National Metrology Institute of Germany (PTB), with target values of certified reference material, within the RELA scheme, and to >1500 results from routine laboratories. Results: Overall deviations between three CLs were ≤0.5% (n = 24 samples) in a measurement range of 20 g/L to 300 g/L. A CV of 0.4% was determined in pooled blood (1 year long-term imprecision, 99.0%–101.1% recovery of the mean). For selected measurements (n = 4 samples) the PTB participated without significant differences to three CLs, and no significant differences were observed comparing CLs to certified values of reference materials. The expanded measurement uncertainty (probability 95%) was estimated as 1.1%. Conclusions: A reference measuring system, comprising measuring instruments and other devices, including reagents and supply, to generate reference measurement values for total Hb concentration of high accuracy and low measurement uncertainty is presented. Measurement parameters are investigated and defined. The reference measuring system is ready to offer service to EQA providers and to the IVD industry for certifying control materials or calibrators. [ABSTRACT FROM AUTHOR]

Durch den großflächigen Einsatz der Computertomographie (CT) in unterschiedlichen Industriebereichen steigen auch die Anforderungen an die quantitative Bildanalyse. Subjektive Bildwahrnehmung muss durch objektive Algorithmen ersetzt werden. In diesem Artikel stellt die Bundesanstalt für Materialforschung und -prüfung (BAM), die seit den 1980er Jahren an der Entwicklung der industriellen CT beteiligt ist, anhand ausgewählter Beispiele den aktuellen Stand ihrer Analysemethoden an verschiedenen Anwendungsbeispielen der CT vor. The increasing use of computed tomography (CT) in various industrial sectors requires more sophisticated techniques of quantitative image analysis. Subjective image perception needs to be replaced by objective algorithms. The German Federal Institute for Materials Research and Testing (BAM) has been involved in the development of industrial CT since the 1980s. This paper summarizes the current status of quantitative 3D image analysis techniques based on selected examples. [ABSTRACT FROM AUTHOR]

Background: The importance of the standardisation of immunoassays for autoantibodies has been widely discussed. The appropriate use of certified reference materials (CRM) could contribute to a more accurate diagnosis and follow-up of a series of diseases such as small vessel-associated vasculitis. This is a systemic autoimmune disorder during which two autoantibodies can be present, MPO ANCA IgG and PR3 ANCA IgG. Results from different commercially available immunoassays used for PR3 ANCA IgG measurement can vary significantly. Therefore the potential for improvement using a suitable certified reference material was assessed and led to the development of a CRM. Methods: Thirty clinical samples were evaluated using 10 immunoassays. The correlation between results from these assays was assessed in a pairwise manner. Feasibility studies were conducted in order to find a reference material format most suitable for the preparation of a CRM. Results: The evaluation of two sets of 30 clinical samples with 10 assays showed that differences between assays can result in different interpretations for individual clinical samples. Most of the samples had the same result classification in all assays. However, six of the samples tested led to inconsistent results. Conclusions: The correlation between results from clinical samples was systematically good for combinations of eight of those assays. Therefore, it should be possible to improve the comparability of results using a commutable CRM for calibration. Based on these studies, a final format for the CRM was selected and eventually produced and certified for its PR3 ANCA IgG content. [ABSTRACT FROM AUTHOR]

This paper aims to assess whether the emerging research paradigm of the new speaker may be useful in the study of language history. This question is tackled by exploring the dynamics which arose between Florentines and non-Florentine learners in sixteenth-century Italy. At the time, notwithstanding the peninsula's linguistic fragmentation, the written language came to be progressively standardised around an archaic variety of Florentine (the fourteenth-century vernacular used by Dante, Petrarch and Boccaccio). Florentines, initially, had no active role in this process and literary Florentine was living an autonomous life, becoming, at the written level, a "learner" variety progressively influenced by its new users. If at first Florentines themselves saw the emerging exogenous written standard in negative terms, they were not immune to its influence – an influence which grew stronger as the century progressed. The dynamics which arose between Florentines and learners concerning linguistic ownership appear similar to the ones which exist between "traditional" linguistic minorities and new speakers in some present-day revitalisation contexts. It is argued that the "new speaker" lens, mainly employed in the field of endangered languages, is valuable for capturing the dynamics which emerge between different groups during historical processes of language standardisation. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus is a major global issue and high quality testing is essential for the diagnosis and treatment of the disease. The IFCC Committee for the Education in the Utility of Biomarkers in Diabetes (C-EUBD) plays a global role in improving knowledge and understanding around diabetes testing. This paper describes a multi-stakeholder approach, to improving diagnostic and therapeutic testing for diabetes, using a multicentre study in China as an example of the global impact of the group. Methods: Educational workshops were developed to support the scientific aims of the study in which 30 centres around China received identical, fresh frozen whole blood samples with values assigned using IFCC secondary reference methods and undertook precision (EP-5) and trueness studies. Performance was assessed using sigma metrics. Results: A successful multi-stakeholder group was developed and sustained throughout the study through several educational workshops, which enabled the formation of a long-term collaboration with key opinion leaders and policy makers in China. All 30 centres showed good performance with within and between laboratory coefficient of variations (CVs) below 3% in SI units at both low and high haemoglobin A1c (HbA1c) levels. All individual laboratories met the criteria of a sigma of two or more at a total allowable error (TAE) of 5 mmol/mol (0.46% NGSP). Conclusions: The study led to a successful multi-partner approach to improving diabetes testing in China. All centres involved in the study meeting the published IFCC quality criteria, paving the way for future clinical trials and an expanded role for HbA1c testing across the country. [ABSTRACT FROM AUTHOR]

The results of medical laboratory testing are only useful if they lead to appropriate actions by medical practitioners and/or patients. An underappreciated component of the medical testing process is the transfer of the information from the laboratory report into the reader's brain. The format of laboratory reports can be determined by the testing laboratory, which may issue a formatted report, or by electronic systems receiving information from laboratories and controlling the report format. As doctors can receive information from many laboratories, interpreting information from reports in a safe and rapid manner is facilitated by having similar report layouts and formats. Using Australia as an example, there is a wide variation in report formats in spite of a body of work to define standards for reporting. In addition to standardising of report formats, consideration needs to be given to optimisation of report formatting to facilitate rapid and unambiguous reading of the report and also interpretation of the data. Innovative report formats have been developed by some laboratories; however, wide adoption has not followed. The need to balance uniformity of reporting with appropriate innovation is a challenge for safe reporting of laboratory results. This paper discusses the current status and opportunity for improvement in safety and efficiency of the reading of laboratory reports, using current practise and developments in Australia as examples. [ABSTRACT FROM AUTHOR]

Background: Thiamine has a crucial role in energy production, and consequently thiamine deficiency (TD) has been associated with cardiac failure, neurological disorders, oxidative stress (lactic acidosis and sepsis) and refeeding syndrome (RFS). This review aims to explore analytical methodologies of thiamine compound quantification and highlight similarities, variances and limitations of current techniques and how they may be relevant to patients. Content: An electronic search of Medline, PubMed and Embase databases for original articles published in peerreviewed journals was conducted. Methods Now was used to search for published analytical methods of thiamine compounds. Keywords for all databases included "thiamine and its phosphate esters", "thiamine methodology" and terms related to critical illness. Enquiries were also made to six external quality assurance (EQA) programme organisations for the inclusion of thiamine measurement. Summary: A total of 777 published articles were identified; 122 were included in this review. The most common published method is HPLC with florescence detection. Two of the six EQA organisations include a thiamine measurement programme, both measuring only whole-blood thiamine pyrophosphate (TPP). No standard measurement procedure for thiamine compound quantification was identified. Outlook: Overall, there is an absence of standardisation in measurement methodologies for thiamine in clinical care. Consequently, multiple variations in method practises are prohibiting the comparison of study results as they are not traceable to any higher order reference. Traceability of certified reference materials and reference measurement procedures is needed to provide an anchor to create the link between studies and help bring consensus on the clinical importance of thiamine. [ABSTRACT FROM AUTHOR]

Case studies in the history of science and technology have shown that scientific norms, so called standards, contribute significantly to the evolution of scientific practices. They arise predominantly, but not exclusively, on the basis of interactions with instruments of measurement and other technical devices. As regards experimental practices standards are mandatory preparatory procedures in a variety of designs, including the inbreeding and genetic engineering of experimental organisms (e.g. transgenic mice). I claim that scientific norms not only regulate mere technical preconditions of research but also guide experimental practices, for example with regard to the stabilisation and validation of phenomena. Against this background, the paper introduces different kinds of scientific norms and elaborates on the question if they are means to epistemic ends (e.g. stability). [ABSTRACT FROM AUTHOR]

The article presents the study on the possible vitamin B12 and folate deficiencies. It states that the active portion of B12 available to cells called holotranscobalamin (holoTC) is a specific marker of early B12 deficiency than total B12. It mentions the reduction in inter-laboratory variability when holoTC levels in serum samples were determined relative to international standard (IS) for vitamin B12 and serum folate 03/178.

The serum free light chain (FLC) assay has proven to be an important complementary test in the management of patients with monoclonal gammopathies. The serum FLC assay has value for patients with plasma cell disorders in the context of screening and diagnosis, prognostic stratification, and quantitative monitoring. Nonetheless, serum FLC measurements have analytical limitations which give rise to differences in FLC reporting depending on which FLC assay and analytical platform is used. As the FLC measurements are incorporated in the International Myeloma Working Group guidelines for the evaluation and management of plasma cell dyscrasias, this may directly affect clinical decisions. As new certified methods for serum FLC assays emerge, the need to harmonise patient FLC results becomes increasingly important. In this opinion paper we provide an overview of the current lack of accuracy and harmonisation in serum FLC measurements. The clinical consequence of non-harmonized FLC measurements is that an individual patient may or may not meet certain diagnostic, prognostic, or response criteria, depending on which FLC assay and platform is used. We further discuss whether standardisation of serum FLC measurements is feasible and provide an overview of the steps needed to be taken towards harmonisation of FLC measurements. [ABSTRACT FROM AUTHOR]

New measurements have been undertaken to determine the half-life of 151Sm. A pure 151Sm solution was obtained after chemical separation from a samarium solution resulting from the dissolution of an irradiated samarium sample. The concentration of 151Sm in the solution was measured by mass spectrometry, combined with the isotope dilution technique. The activity of the solution was measured by liquid scintillation counting by six European laboratories as part of an international comparison. These combined results lead to a half-life of T1/2 = 94.6(6) a. [ABSTRACT FROM AUTHOR]

It has been observed that language-shift varieties of English tend to be relatively close to Standard English (Trudgill and Chambers 1991: 2-3). An oftenused explanation for this is that Standard English was acquired in schools by the shifting population (Filppula 2006: 516). In this paper, I discuss three cases of language shift in the Early Modern period: in Cornwall, the Isle of Man, and Shetland. I offer evidence that the role of Standard English education was, in fact, fairly limited, and suggest that the standard-likeness of Cornish English, Manx English and Shetland Scots is most likely due to the particular sociolinguistic circumstances of language shift, where not only language contact, but also dialect contact contributed to a loss of non-standard-like features and the acquisition of a standard-like target variety. This atelic and non-hierarchical process is termed apparent standardisation. [ABSTRACT FROM AUTHOR]

Background: The measurement of serum IgE aids in the diagnosis and management of atopic allergic disease and hyper-IgE immunodeficiency syndromes. The 2nd World Health Organization (WHO) International Reference Reagent (IRR) for serum IgE (75/502; 5000 IU/ampoule), is widely used to calibrate assays for serum IgE. Exhaustion of stocks of the 2nd IRR necessitated the production of a replacement preparation and its evaluation in an international collaborative study to determine its suitability to serve as the 3rd International Standard (IS) for serum IgE. Methods: Sera and defibrinated plasma with elevated IgE levels were pooled and lyophilised in ampoules. This preparation, coded 11/234, was assayed by 18 laboratories in 11 countries using commercial assay methodology for IgE, along with the 2nd IRR, 75/502, and two lyophilised serum samples. Results: Overall, there were no consistent differences in the way that the candidate IS (11/234), the IRR (75/502), and the two serum samples behaved in the assays with respect to linearity and parallelism. The mean IgE value of the candidate IS, 11/234, relative to the IRR, 75/502, was 13,411 IU/mL based on parallel line analysis of raw assay data at NIBSC, and 13,551 IU/mL based on the laboratories’ own estimates after correcting for the values obtained for 75/502. Conclusions: The use of 11/234 will ensure that assays for serum IgE continue to be well standardised. The preparation was established by the WHO Expert Committee on Biological Standardization as the 3rd IS for serum IgE with an assigned value of 13,500 IU/mL, corresponding to 6750 IU/ampoule. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article regarding a research on cooperative multicentre to identify the upper limits of normal for some tests applied in the diagnostic assessment of lupus anticoagulant by P. Pradella and colleagues in the 2013 issue.

The central importance of HbA1c in monitoring glycaemic control was highlighted by the Diabetes Control and Complications Trial (DCCT) which showed that improved glycaemic control, as monitored by HbA1c, delayed the onset of diabetic complications. Following this publication the issue of international standardisation of glycated haemoglobin (GHb) measurements became an important objective. The lack of international standardisation resulted in several countries developing National Standardisation Programmes. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on HbA1cStandardisation has established a reference measurement procedure (HPLC-MS or HPLC-CE) for HbA1c embracing the concept of metrological traceability. The reference method is anchored to a global network of 15 approved reference laboratories; this confers sustainability and a low level of uncertainty. Essential elements of a comprehensive reference measurement system additionally include the definition of the measurand and the unit of measurement. HbA1c is defined as haemoglobin (Hb) molecules having a stable adduct of glucose to the N-terminal valine of the β chain [Hb β chain (Blood) - N-(1-deoxyfructos-1-yl) Hb β chain] and that mmol/mol be used as the unit of measurement. These developments will result in improvements in inter-method and inter-laboratory agreement. Additionally, global acceptance of standardisation based on metrologically sound principles will enable clinical goals and diagnostic guidelines to be developed that can be adopted by all countries. [ABSTRACT FROM AUTHOR]

Casual or systematic errors occurring in pre-analytical, analytical or post-analytical phases influence laboratory test results. The areas where pre-analytical phase errors most often arise are: timing of specimen collection; selection of specimen type; and time and temperature of storage/transport. Bone turnover markers are clinically useful in evaluating bone metabolism. Although unquestionably valuable tools, little is known about the pre-analytical precautions for their correct use and there is no consensus on kind of sample, or storage time and temperature before analysis. Moreover, biological variability, because of uncontrollable and controllable factors, will affect pre-analytical variability. Serum should be preferred to simplify blood drawing; therefore, only one tube should be used for the analysis of all bone markers. Short-term storage at 4°C may be advisable to preserve stability, immediate storage at -70°C is recommended for longer periods, while avoiding repeated freeze-thawing cycles. Sampling should be performed in the morning in fasting subjects who have abstained from physical exercise for 24 h. This review aimed to give a knowledge update on pre-analytical phase precautions in performing bone turnover marker measurement. [ABSTRACT FROM AUTHOR]

To date not much importance has been given to the sorting of examined properties ('tests') in clinical laboratory reports. The present article contains a proposal about sorting the examined properties of clinical laboratory reports, in order to facilitate their interpretation to the requesting physicians. This proposal is mainly based on clinical and patho-physiological criteria. A set of groups of properties has been established according to the main clinical indications of each property. Some of these properties have several clinical indications and, consequently, have been included in more than one group. Some of these groups have been associated to other groups, so that the properties conforming them will always appear consecutively, since they are patho-physiologically related. Finally, an association between each group with the different medical specialities or areas of knowledge has been made, according to the clinical indications of each property. The groups of properties proposed are in concordance with their main clinical indications and their patho-physiological relationship. This ordering system gives priority, first, to the alarm (critical) values and, second, to the medical speciality or knowledge area of the requesting physician. This proposal can help the requesting physician to see first of all the most relevant clinical laboratory information related to her/his patient. [ABSTRACT FROM AUTHOR]

This study summarises the possible, necessary and recommended steps to align consumer behaviour and the standard place setting used for performance and consumption measurements of domestic dishwashers. The diversity and amount of load items, the composition of the dish materials and the amount of soiling in real life differ from the standard place setting. Through the analysis of secondary data regarding the dish-ware cleaned in household dishwashers, the development of a new, more consumer relevant place setting was possible. Apart from a reduction of the total amount of load items, new materials and items were introduced. The durability and availability of the dishes has been guaranteed and reproducible and differentiating soiling for the new dish items has been developed. Although laboratory tests revealed that the new place setting caused slightly different cleaning results, it still delivers differen-tiable results concerning the performance parameters of dishwashers. Finally, it reflects the actual usage of a dishwasher in the household much better than the current place setting, and standard test results may gain in importance for the consumer. [ABSTRACT FROM AUTHOR]

Background: Quantification of monoclonal immunoglobulin free light chains (FLCs) in serum is used increasingly in clinical practice for the diagnosis, prognostic assessment, and treatment monitoring of monoclonal gammopathies. It is used as an adjunct to standard serum protein electrophoresis and immunofixation. However, methods for FLC quantification need further standardization and validation. Methods: The Czech Myeloma Group and the Czech Society of Clinical Biochemistry have initiated an interlaboratory study where six laboratories collaborating with the primary myeloma treatment centres measured FLC concentrations in 12 serum samples from patients with monoclonal gammopathies. Results: Repeatability of the measurements in five laboratories was calculated based on differences between the results of duplicate measurements. We found that repeatability depended more on the laboratory than on the device used for measurement. Conclusions: The study revealed several weak points in the methodology, including the need for a uniform sample dilution procedure. Interlaboratory reproducibility was comparable with values achieved in the NEQAS programme. Because the κ/λ ratio cannot be measured with high precision, κ and λ FLC concentrations should be used where possible. Due to its impact on the clinical management of patients with gammopathy, FLC quantification needs to become a part of the regular quality control cycle in myeloma centres. [ABSTRACT FROM AUTHOR]

The prothrombin time (PT) assay is the most often requested coagulation test and used primarily for monitoring Vitamin K antagonist therapy, where results may be expressed as an International Normalised Ratio (INR). The INR is the patient's PT ‘mathematically adjusted’ or ‘standardised’ to take into account the specific test system used (i.e., comprising the test reagent/instrument combination). This standardisation or ‘adjustment’ is achieved by applying two ‘correction factors’, respectively defined by the ‘International Sensitivity Index’ (ISI) and the ‘mean normal prothrombin time’ (MNPT), according to the formula: INR=[patient PT/MNPT]ISI. While some manufacturers provide assigned ISI values for specific PT reagents and instrumentation, the vast number of possible reagent/instrument combinations usually precludes this in most situations. Even when an ISI is provided by the manufacturer, laboratories need to check or validate the assigned value. When a manufacturer does not provide an ISI, the laboratory needs to define its own (local ISI) value. The MNPT usually has to be locally defined, based on the population being tested. Current recommendations for defining ISI values include the classical, but prohibitively complex, World Health Organization (WHO) recommended procedure, and more recently the use of commercial reference-plasma calibration sets. The MNPT can also be defined using the WHO recommended procedure or with calibration sets. However, there is limited information to validate the performance of these in laboratory practice, and there are several unrecognised problems that limit the validity and utility of the ISI and MNPT values that are determined. Thus, it is perhaps time to start thinking outside the box, and to utilise additional methods for determining and/or validating ISI and MNPT values. This may include the use of regression analysis to assess ongoing peer-related performance in external quality assurance programmes, and to compare the behaviour of proposed replacement reagents with that of existing reagents. Such strategies have proven of considerable benefit to local laboratory practice, and should therefore enable other laboratories to optimise their practice in order to provide INRs that better reflect a patient's anticoagulant status, and thus assist in their clinical therapeutic management. Clin Chem Lab Med 2010;48:1079–90. [ABSTRACT FROM AUTHOR]

The present article argues that the social category of 'standardisation' has been instrumental in creating a Foucaultian discourse archive governing what may and what may not be stated on the subject of the history of English. It analyses the question of how language attitudes have been instrumental in creating the myths that have driven the discourse of Standard English since the 19th century, but it goes further than this by showing how language performance, in the form of folk songs in England, has also come under this same archive of standardisation. However, in both cases, i.e. language and language performance, it is argued that a below-the-surface alternative discourse has now gained enough force to seriously challenge the doctrine of standardisation and to necessitate the formation of new discursive contents for a social concept that is in serious danger of becoming hollow and outdated. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Laboratory Medicine / Laboratoriums Medizin is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The German guidelines for early detection of prostate cancer propose the use of digital rectal palpation and prostate specific antigen (PSA). PSA levels above 4 μg/L are considered to be suspect. However, method comparison of six different assays resulted in differences up to 20% in the range of 4 μg/L, although all assays used the Stanford 90/10 (WHO 96/670) calibration. Interpretation of PSA levels therefore has to take into consideration assay-specific characteristics, using assay-specific local reference ranges. However, the estimation of reference ranges by, e.g., analysis of frequency distribution failed with regard to the high prevalence of benign prostate hyperplasia. PSA velocity is proposed for early detection. Interpretation of PSA velocity especially at low PSA levels has to take into consideration analytical imprecision and biological variation. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Laboratory Medicine / Laboratoriums Medizin is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: HbA1c (glycohaemoglobin) is universally used in the ongoing monitoring of all patients with diabetes. There are many % HbA1c target control rating recommendations by national, regional and international expert bodies for diabetes patients and these are variable around the world. General patient target control ratings are currently most often recommended as either <6.5% or <7.0% HbA1c, with <6.0% HbA1c stated for individual patients where clinically possible. This necessitates very precise HbA1c assays and the same patient values, irrespective of HbA1c method or area of the world. Methods: HbA1c targets recommended by major expert groups and published HbA1c assay precision (coefficient of variation, %CV) levels have been detailed. These have been compared with published biological variation levels and with calculated HbA1c error ranges at various HbA1c levels and %CV levels. In addition, these have been compared with the analytical precision necessary to differentiate between the upper limit of the normal range for HbA1c and targets recommended by expert groups for diabetes control. Results: Intralaboratory analytical CVs of <2% are necessary and are achievable on automated HPLC analysers, and are supported on grounds of both clinical need and biological variation, as well as the need to differentiate the national, regional and international target recommendations from the upper limit of the normal range (<6.0% HbA1c level). Conclusions: Routine methods with tight long-term imprecision with CVs of <2% are recommended. International HbA1c targets essentially require that all HbA1c methods be precise, and have minimal standardisation bias and minimal methodological interferences in individual patients. Clin Chem Lab Med 2007;45:1083–97. [ABSTRACT FROM AUTHOR]

Background: Vitamin B12 and folate measurements in serum show wide inter-methodology variability. This variability appears to be due in part to the lack of standardisation against internationally accepted reference materials. Pooled human serum, lyophilised in ampoules and designated 03/178, was therefore evaluated by 24 laboratories in seven countries for its suitability to serve as an International Standard (IS) for B12 and folate. Methods: IS 03/178 was assayed using a range of commercial analysers, microbiological assays and, for folate, candidate reference methods based on liquid chromatography coupled to isotope-dilution tandem mass spectrometry (LC/MS/MS). Results: Mean vitamin B12 and folate values for reconstituted 03/178 across all laboratories and methods were 480 pg/mL [coefficient of variation (CV) 12.8%] and 5.52 ng/mL (CV 17.1%), respectively. The total folate content of reconstituted 03/178, determined using LC/MS/MS, was 12.1 nmol/L (equivalent to 5.33 ng/mL), made up of 9.75 nmol/L 5-methyl tetrahydrofolic acid (5MeTHF; CV 5.5%), 1.59 nmol/L 5-formyl tetrahydrofolic acid (5FoTHF; CV 4.2%) and 0.74 nmol/L folic acid (FA; CV 31.6%). The inclusion of three serum samples in the study with different B12 and folate levels demonstrated a considerable reduction in inter-laboratory variability when the B12 and folate content of the samples was determined relative to the IS 03/178 rather than to the analyser calibration. IS 03/178 demonstrated satisfactory long-term stability in accelerated degradation studies. Conclusions: Use of IS 03/178 to standardise serum B12 and folate assays reduced inter-laboratory variability. The World Health Organization (WHO) Expert Committee on Biological Standardisation established 03/178 as the first IS for serum vitamin B12 and serum folate, with assigned values of 480 pg/mL of vitamin B12 and 12.1 nmol/L folate when the lyophilised contents of the ampoule are reconstituted with 1 mL of water. Clin Chem Lab Med 2007;45:380–6. [ABSTRACT FROM AUTHOR]

Background: Owing to remarkable advances in automation, laboratory technology and informatics, the pre-analytical phase has become the major source of variability in laboratory testing. The present survey investigated the development of several pre-analytical processes within a representative cohort of Italian clinical laboratories. Methods: A seven-point questionnaire was designed to investigate the following issues: 1a) the mean outpatient waiting time before check-in and 1b) the mean time from check-in to sample collection; 2) the mean time from sample collection to analysis; 3) the type of specimen collected for clinical chemistry testing; 4) the degree of pre-analytical automation; 5a) the number of samples shipped to other laboratories and 5b) the availability of standardised protocols for transportation; 6) the conditions for specimen storage; and 7) the availability and type of guidelines for management of unsuitable specimens. The questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006. Results: 107 questionnaires (71.3%) were returned. Data analysis revealed a high degree of variability among laboratories for the time required for check-in, outpatient sampling, sample transportation to the referral laboratory and analysis upon the arrival. Only 31% of laboratories have automated some pre-analytical steps. Of the 87% of laboratories that ship specimens to other facilities without sample preparation, 19% have no standardised protocol for transportation. For conventional clinical chemistry testing, 74% of the laboratories use serum evacuated tubes (59% with and 15% without serum separator), whereas the remaining 26% use lithium-heparin evacuated tubes (11% with and 15% without plasma separator). The storage period and conditions for rerun/retest vary widely. Only 63% of laboratories have a codified procedure for the management of unsuitable specimens, which are recognised by visual inspection (69%) or automatic detection (29%). Only 56% of the laboratories have standardised procedures for the management of unsuitable specimens, which vary widely on a local basis. Conclusions: The survey highlights broad heterogeneity in several pre-analytical processes among Italian laboratories. The lack of reliable guidelines encompassing evidence-based practice is a major problem for the standardisation of this crucial part of the testing process and represents a major challenge for laboratory medicine in the 2000s. Clin Chem Lab Med 2006;44:1491–4. [ABSTRACT FROM AUTHOR]

Background: Proteomics' requirement for simultaneous measurement of multiple markers is now possible with biochip array technology. Many laboratories utilise in-house, manual procedures for biochip fabrication and sample testing. Reproducibility and standardisation of biochip processes is vital to ensure quality of results and offer the best tool for elucidation of complex relationships between multiple proteins in diseased conditions. Methods: Various novel control checks have been implemented in biochip fabrication, reagent manufacture, automation and imaging processes for the Evidence analyser. Reference spots enable location of discrete test regions on the surface of the biochip and simultaneous quantification of multiple markers. Performance and standardisation methods are presented. Results: Formulation of dispense solution for discrete test regions had a direct effect on their shape, stability and integrity on the biochip surface. Assays for fertility hormones and drugs of abuse demonstrated excellent precision, stability and comparison with other commercial methods. Conclusion: Control processes employed in the manufacture and analysis of Evidence components ensure reproducibility of assays for a range of routine and novel markers. [ABSTRACT FROM AUTHOR]

Folate measurements, particularly for whole blood, show wide inter-laboratory and inter-methodology variability. This variability appears to be due in part to the lack of internationally accepted reference materials. A whole blood haemolysate, lyophilised in ampoules and designated 95/528, was therefore evaluated by 15 laboratories in five countries for its suitability as an International Standard (IS) for whole blood folate. The preparation was assayed using a variety of microbiological and protein-binding methodologies against local standards and calibrators. A consensus folate content was assigned to 95/528. The inclusion of three whole blood samples in the study with widely differing folate levels demonstrated a considerable reduction in inter-laboratory variability when the folate content of the samples was determined relative to the proposed IS 95/528 rather than to laboratories' local standards and calibrators. Accelerated degradation studies indicated that the folate content of 95/528 is stable when stored at -20°C. On the basis of the results presented here, the World Health Organization Expert Committee on Biological Standardization established 95/528 as an IS for whole blood folate. [ABSTRACT FROM AUTHOR]

Although the concept of Evidence-Based Medicine (EBM) is quite popular among English speaking physicians, it still needs to be adopted by an overwhelming majority of health care professionals in countries where English is not familiar. Thus, this concept can be translated in many different, and potentially misleading, ways. This is regrettable because the concept is, at least potentially, a very useful one. As an illustration, I have compiled some of the French translations of EBM that are currently in use in French speaking countries, and indicated briefly how most of these translations (except for one) are bound to be misleading. Many of these misleading translations currently in use strongly suggest that it is time for an international standardisation of the translations of EBM in different languages. Clin Chem Lab Med 2010;48:1227-8. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an article on the standardization of haemoglobin A1c (HbA1c).