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Clinical Chemistry and Laboratory Medicine: CCLM

Eric F Glassy, David J Blomberg
No abstract text is available yet for this article.
May 23, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Yiting Xu, Xiaojing Ma, Qin Xiong, Xueli Zhang, Yun Shen, Yuqian Bao
BACKGROUND: Our study examined whether osteocalcin contributed to identifying carotid intima-media thickness (C-IMT) over the atherosclerotic cardiovascular disease (ASCVD) risk score. METHODS: We recruited 618 middle-aged and elderly men from communities in Shanghai. Serum osteocalcin levels were determined using an electrochemiluminescence immunoassay. C-IMT was measured by ultrasonography. RESULTS: The study included 245 men with low ASCVD risk and 373 men with moderate-to-high ASCVD risk...
May 19, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Ellen M H Schmitz, Niels M Leijten, Joost L J van Dongen, Maarten A C Broeren, Lech G Milroy, Luc Brunsveld, Volkher Scharnhorst, Daan van de Kerkhof
BACKGROUND: Targeted quantification of protein biomarkers with liquid chromatography-tandem mass spectrometry (LC-MS/MS) has great potential, but is still in its infancy. Therefore, we elucidated the influence of charge state distribution and matrix effects on accurate quantification, illustrated by the peptide hormone hepcidin. METHODS: An LC-MS/MS assay for hepcidin, developed based on existing literature, was improved by using 5 mM ammonium formate buffer as mobile phase A and as an elution solution for solid phase extraction (SPE) to optimize the charge state distribution...
May 19, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Karl J Lackner, Mario Plebani
No abstract text is available yet for this article.
May 16, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Panagiota S Filippou, Annie H Ren, Dimitrios Korbakis, Lampros Dimitrakopoulos, Antoninus Soosaipillai, Vivian Barak, Shahar Frenkel, Jacob Pe'er, Michal Lotem, Sharon Merims, Rafael Molina, Ivan Blasutig, Dimitrios P Bogdanos, Eleftherios P Diamandis
BACKGROUND: Mucin 13 (MUC13) is a cell surface glycoprotein aberrantly expressed in a variety of epithelial carcinomas. Thus far, the role of MUC13 in various diseases remains elusive. To the best of our knowledge, this is the first study to examine the potential of MUC13 as a serum biomarker in a variety of carcinomas and other conditions. METHODS: We developed a recombinant MUC13 protein, mouse monoclonal antibodies and enzyme immunoassay (ELISA) for MUC13. We used this assay to measure MUC13 levels in the supernatants of cancer cell lines and a large cohort of serum samples from healthy and diseased individuals...
May 16, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Anne Stavelin, Sverre Sandberg
Noklus is a non-profit quality improvement organization that focuses to improve all elements in the total testing process. The aim is to ensure that all medical laboratory examinations are ordered, performed and interpreted correctly and in accordance with the patients' needs for investigation, treatment and follow-up. For 25 years, Noklus has focused on point-of-care (POC) testing in primary healthcare laboratories and has more than 3100 voluntary participants. The Noklus quality system uses different tools to obtain harmonization and improvement: (1) external quality assessment for the pre-examination, examination and postexamination phase to monitor the harmonization process and to identify areas that need improvement and harmonization, (2) manufacturer-independent evaluations of the analytical quality and user-friendliness of POC instruments and (3) close interactions and follow-up of the participants through site visits, courses, training and guidance...
May 16, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Jhonatan Wong-Arteta, Anna Merino, Silvia Torrente, Jesus M Banales, Luis Bujanda
No abstract text is available yet for this article.
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Clare Fiala, Eleftherios P Diamandis
In this piece we discuss and reflect on the conclusion of the Theranos saga in the light of its fraud conviction. Theranos (founded in 2003 by Elizabeth Holmes) was supposed to disrupt the diagnostic testing industry by developing technology which could perform dozens of tests using a tiny amount of blood from a finger-prick. As a result, Ms. Holmes rose to fame, becoming the world's youngest female self-made billionaire and was plastered across magazine covers. However, in 2014, Theranos began to fall apart following increasingly damaging revelations regarding its lack of expertise, technology, framework, extreme secrecy and inaccurate test results...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Tinne Monteyne, Renaat Coopman, Antoine S Kishabongo, Jonas Himpe, Bruno Lapauw, Samyah Shadid, Elisabeth H Van Aken, Darja Berenson, Marijn M Speeckaert, Thomas De Beer, Joris R Delanghe
BACKGROUND: Glycated keratin allows the monitoring of average tissue glucose exposure over previous weeks. In the present study, we wanted to explore if near-infrared (NIR) spectroscopy could be used as a non-invasive diagnostic tool for assessing glycation in diabetes mellitus. METHODS: A total of 52 patients with diabetes mellitus and 107 healthy subjects were enrolled in this study. A limited number (n=21) of nails of healthy subjects were glycated in vitro with 0...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Andre Valcour, Claudia Zierold, Frank A Blocki, Douglas M Hawkins, Kevin J Martin, Sudhaker D Rao, Fabrizio Bonelli
BACKGROUND: Over the past few decades, parathyroid hormone (PTH) immunoassays have progressed through successive generations resulting in increased specificity and accuracy for detecting circulating PTH. With the introduction of third-generation assays, in which the biologically active PTH(1-84) is specifically targeted, the PTH(7-84) and other fragments are not detected. The specific recognition of only PTH(1-84) whole molecule allows for more reliable standardization and calibration than with the existing assays...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Agnieszka Ćwiklińska, Hanna Dąbrowska, Robert Kowalski, Agnieszka Kuchta, Barbara Kortas-Stempak, Aleksandra Fijałkowska, Gabriela Bednarczuk, Maciej Jankowski
BACKGROUND: The ratio of albumin to creatinine (ACR) is an important parameter used for detection of albuminuria in patients with early kidney damage. The aim of the study was to evaluate the harmonization of ACR results among Polish participants in an international external quality assessment (EQA) program, and to evaluate the impact of albumin and creatinine analytical performance on the harmonization of ACR results. METHODS: We analyzed 182 results of albumin, 202 of creatinine, and 180 of ACR obtained from Polish laboratories in an EQA program organized by Labquality...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Britta Willman, Kjell Grankvist, Karin Bölenius
BACKGROUND: When performed erroneously, the venous blood specimen collection (VBSC) practice steps patient identification, test request management and test tube labeling are at high risk to jeopardize patient safety. VBSC educational programs with the intention to minimize risk of harm to patients are therefore needed. In this study, we evaluate the efficiency of a large-scale online e-learning program on personnel's adherence to VBSC practices and their experience of the e-learning program...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Sandra Secchiero, Laura Sciacovelli, Mario Plebani
BACKGROUND: The need to harmonize laboratory information is particularly intense in the field of plasma proteins, considering their clinical impact and relevance in monitoring diseases. METHODS: We evaluated units and reference intervals (RIs) utilized by participants of the External Quality Assessment Scheme (EQAS) for plasma proteins of the Centre of Biomedical Research. Moreover, we evaluated inter-laboratory analytical variability from 2001 to 2017. RESULTS: The census of participants' units employed in 2017 showed that for albumin (ALB), ~66% of laboratories still used dL instead of L, and for most other proteins, ~70% still expressed the results in mg/dL...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Varsha Varakantham, Ashok Kumar Kurakula Sailoo, Balakrishna Nagalla, Dinesh Kumar Bharatraj
BACKGROUND: β1-Adrenoreceptor (ADRB1) genetic polymorphisms are widely studied for susceptibility to many cardiovascular diseases such as essential hypertension. However, the mRNA expression of ADRB1 is rarely studied. METHODS: A case-control pilot study with 292 hypertensives and 324 controls was designed to evaluate the role of the Ser49Gly and Arg389Gly, which are commonly studied single nucleotide polymorphisms (SNP), in the mRNA levels of ADRB1, in conjunction with its genetic predisposition to essential hypertension...
May 11, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Giacomo Montagna, Samuela Balestra, Federica D'Aurizio, Francesco Romanelli, Cinzia Benagli, Renato Tozzoli, Lorenz Risch, Luca Giovanella, Mauro Imperiali
BACKGROUND: The total testosterone (T) cutoffs clinically adopted to define late-onset hypogonadism (LOH) do not consider the differences that exist between different analytical platforms, nor do they consider the body mass index (BMI) or age of the patient. We aimed at providing method, age and BMI-specific normal values for total T in European healthy men. METHODS: A total of 351 eugonadal healthy men were recruited, and total T was measured with four automated immunometric assays (IMAs): ARCHITECT i1000SR (Abbott), UniCel DxI800 (Beckman Coulter), Cobas e601 (Roche), IMMULITE 2000 (Siemens) and liquid chromatography-tandem mass spectrometry (LC-MS/MS)...
May 10, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Christa Cobbaert, Nico Smit, Philippe Gillery
In our efforts to advance the profession and practice of clinical laboratory medicine, strong coordination and collaboration are needed more than ever before. At the dawn of the 21st century, medical laboratories are facing many unmet clinical needs, a technological revolution promising a plethora of better biomarkers, financial constraints, a growing scarcity of well-trained laboratory technicians and a sharply increasing number of International Organization for Standardization guidelines and new regulations to which medical laboratories should comply in order to guarantee safety and effectiveness of medical test results...
May 7, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Sofia Michele Dick, Marina Queiroz, Letícia Almeida Brondani, Angélica Dall'Agnol, Bárbara Luisa Bernardi, Sandra Pinho Silveiro
No abstract text is available yet for this article.
May 5, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Bernardino Barceló, Adrian Rodriguez, Marta Ocon Lopez, Antonia Costa-Bauza, Isabel Gomila, Maria Blanca Badal Cogul, Félix Grases
No abstract text is available yet for this article.
May 5, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Andrea Padoan, Renata D'Incà, Maria Luisa Scapellato, Rudi De Bastiani, Roberta Caccaro, Claudia Mescoli, Stefania Moz, Dania Bozzato, Carlo-Federico Zambon, Greta Lorenzon, Massimo Rugge, Mario Plebani, Daniela Basso
BACKGROUND: The appropriate clinical use of fecal calprotectin (fCal) might be compromised by incomplete harmonization between assays and within- and between-subjects variability. Our aim was to investigate the analytical and biological variability of fCal in order to provide tools for interpreting fCal in the clinical setting. METHODS: Experiments were conducted to investigate the effects of temperature and storage time on fCal. Thirty-nine controls were enrolled to verify biological variability, and a case-control study was conducted on 134 controls and 110 IBD patients to compare the clinical effectiveness of three different fCal assays: ELISA, CLIA and turbidimetry...
May 5, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Pim M W Janssens, Armando van der Horst
BACKGROUND: Practical application of prospective risk analysis (PRA) in clinical laboratories should reflect processes as they are carried out, while making the PRA results obtained from different processes comparable. This means that not only STAT and standard testing and testing for critical and less critical parameters should be distinguished (as published), but also that the throughput in processes and process steps should be taken into account. METHODS: Building on our previously published PRA, a method was developed to compensate for the throughput in processes and process steps...
May 5, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
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