journal
Journals Clinical Chemistry and Laborat...

Clinical Chemistry and Laboratory Medicine : CCLM

https://read.qxmd.com/read/36957995/sars-cov-2-specific-t-cell-humoral-response-assessment-after-covid-19-vaccination-using-a-rapid-direct-real-time-pcr-amplification
#1
JOURNAL ARTICLE
Chiara Cosma, Luisa Galla, Andrea Padoan, Giulia Furlan, Lucio Marchioro, Martina Zaninotto, Daniela Basso, Mario Plebani
OBJECTIVES: The SARS-CoV-2 immune response is mediated by both humoral and cellular immunity. In this study, SARS-CoV-2 specific cellular immunity was tested by a novel direct real-time PCR (dRT-PCR) assay, targeting mRNA of CXCL10 , and compared with respect to an ELISA measuring interferon gamma (IFN-γ) release. METHODS: Whole blood (Li-He) and serum samples were collected from 92 healthcare workers (HCW), with three doses of homologous (Pfizer/BioNTech, n=74) or heterologous (Pfizer/BioNTech and Vaxzevria or Moderna, n=18) vaccinations...
March 24, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36952682/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
#2
JOURNAL ARTICLE
Judith Taibon, Tobias Santner, Neeraj Singh, Sara Cheikh Ibrahim, Galina Babitzki, Daniel Köppl, Alexander Gaudl, Andrea Geistanger, Uta Ceglarek, Manfred Rauh, Christian Geletneky
OBJECTIVES: An isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC MS/MS)-based candidate reference measurement procedure (RMP) for aldosterone quantification in human serum and plasma is presented. METHODS: The material used in this RMP was characterized by quantitative nuclear magnetic resonance (qNMR) to assure traceability to SI Units. For liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis a two-dimensional heart cut LC approach, in combination with an optimal supported liquid extraction protocol, was established for the accurate analysis of aldosterone in human serum and plasma in order to minimize matrix effects and avoid the co-elution of interferences...
March 24, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36952681/antibody-mediated-interferences-affecting-cardiac-troponin-assays-recommendations-from-the-ifcc-committee-on-clinical-applications-of-cardiac-biomarkers
#3
JOURNAL ARTICLE
Ola Hammarsten, Janet V Warner, Leo Lam, Peter Kavsak, Bertil Lindahl, Kristin M Aakre, Paul Collinson, Allan S Jaffe, Amy K Saenger, Richard Body, Nicholas L Mills, Torbjørn Omland, Jordi Ordonez-Llanos, Fred S Apple
The International Federation of Clinical Chemistry Committee on Clinical Applications of Cardiac Biomarkers (IFCC C-CB) provides educational documents to facilitate the interpretation and use of cardiac biomarkers in clinical laboratories and practice. Our aim is to improve the understanding of certain key analytical and clinical aspects of cardiac biomarkers and how these may interplay. Measurements of cardiac troponin (cTn) have a prominent place in the clinical work-up of patients with suspected acute coronary syndrome...
March 24, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36947812/efficiency-evaluation-of-a-sars-cov-2-diagnostic-strategy-combining-high-throughput-quantitative-antigen-immunoassay-and-real-time-pcr
#4
JOURNAL ARTICLE
Luca Bernasconi, Peter Neyer, Michael Oberle, Bettina Schmid, Eileen Martin, Hans Fankhauser, Sebastian Haubitz, Angelika Hammerer-Lercher
OBJECTIVES: Laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has played an important role in the effort to prevent and contain local outbreaks. The aim of this study was to assess the diagnostic accuracy of a new fully automated SARS-CoV-2 laboratory-based antigen assay (CoV2Ag) and to explore the efficiency of a diagnostic algorithm combining antigen and conventional high-throughput molecular assays to address potential future challenges of the SARS-CoV-2 pandemic...
March 22, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36919280/clinical-evidence-requirements-according-to-the-ivdr-2017-746-practical-tools-and-references-for-underpinning-clinical-evidence-of-ivd-mds
#5
JOURNAL ARTICLE
Karine Charrière, Lionel Pazart
In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of in vitro medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance...
March 15, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36913440/early-kinetics-of-cellular-immunity-in-recipients-of-bivalent-bnt162b2-vaccine-a-proof-of-concept-study
#6
LETTER
Gian Luca Salvagno, Laura Pighi, Brandon M Henry, Simone De Nitto, Mario Plebani, Giuseppe Lippi
No abstract text is available yet for this article.
March 13, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36883744/clinical-assessment-of-snibe-maglumi-sars-cov-2-antigen-fully-automated-chemiluminescent-immunoassay
#7
JOURNAL ARTICLE
Laura Pighi, Brandon M Henry, Simone De Nitto, Gianluca Gianfilippi, Gian Luca Salvagno, Mario Plebani, Giuseppe Lippi
OBJECTIVES: Given that SARS-CoV-2 antigen tests will represent a pillar for supporting or surrogating molecular testing in the endemic period, we report here the clinical performance of the new SNIBE Maglumi SARS-CoV-2 antigen fully-automated chemiluminescent immunoassay (MAG-CLIA SARS-CoV-2 Ag). METHODS: The study population consisted of 181 subjects (mean age 61 ± 21 years; 92 females) undergoing coronavirus disease 2019 (COVID-19) testing at the local diagnostic facility, from December 2022 to February 2023...
March 8, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36880940/neurofilament-light-chain-as-neuronal-injury-marker%C3%A2-what-is-needed-to-facilitate-implementation-in-clinical-laboratory-practice
#8
JOURNAL ARTICLE
Burak Arslan, Henrik Zetterberg
Neurobiomarkers have attracted significant attention over the last ten years. One promising biomarker is the neurofilament light chain protein (NfL). Since the introduction of ultrasensitive assays, NfL has been developed into a widely used axonal damage marker of relevance to the diagnosis, prognostication, follow-up, and treatment monitoring of a range of neurological disorders, including multiple sclerosis, amyotrophic lateral sclerosis, and Alzheimer's disease. The marker is increasingly used clinically, as well as in clinical trials...
March 7, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36877616/a-consistency-analysis-of-common-biochemical-tests-in-arterial-blood-and-venous-blood-of-critically-ill-patients
#9
LETTER
Nannan Han, Ruhui Pan, Xuejun Zhang, Meimei Wu, Yanmin Chen, Wenge Yu, Xinyao Li, Hongxiang Xie
No abstract text is available yet for this article.
March 7, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36877870/lower-accuracy-of-testosterone-cortisol-and-free-t4-measurements-using-automated-immunoassays-in-people-undergoing-hemodialysis
#10
JOURNAL ARTICLE
Heleen I Jansen, Antonius E van Herwaarden, Henk J Huijgen, Marc G Vervloet, Jacquelien J Hillebrand, Anita Boelen, Annemieke C Heijboer
OBJECTIVES: Hormone measurements using automated immunoassays (IAs) can be affected by the sample matrix. Liquid chromatography tandem-mass spectrometry (LC-MS/MS) is less affected by these matrix effects. In clinical laboratories, testosterone, cortisol and, free thyroxine (FT4) are often measured using IAs. Renal failure alters serum composition in blood samples from people undergoing hemodialysis (HDp) and have, therefore, a complex serum constitution compared to healthy controls (HC)...
March 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36872637/discrepancies-in-psa-values-among-laboratories-the-case-of-a-traveling-patient
#11
LETTER
Xavier Filella, Laura Izquierdo, Joel Mases, Kjell A Youngren, Gines Escolar
No abstract text is available yet for this article.
March 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36872634/impact-of-switching-total-bilirubin-assays-on-the-classification-of-neonates-at-high-risk-for-hyperbilirubinemia
#12
LETTER
Saranya Kittanakom, Jennifer Shea, Felix Leung, Vinh Ly, Sinthu Panchadcharadevan, Sangeet Kathuria, Ivor Margolis, Vilte Barakauskas, Peter A Kavsak
No abstract text is available yet for this article.
March 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36872632/response-to-tony-badrick-regarding-letter-to-the-editor-regarding-the-article-by-wayne-j-%C3%A2-dimech-et%C3%A2-al-time-to-address-quality-control-processes-applied-to-antibody-testing-for-infectious-diseases-clin-chem-lab-med-2023-61-2-%C3%A2-205-212-by
#13
LETTER
Wayne J Dimech, Giuseppe A Vincini, Mario Plebani, Giuseppe Lippi, James H Nichols, Oswald Sonntag
No abstract text is available yet for this article.
March 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36866730/imprecision-remains-to-be-improved-in-the-measurement-of-serum-cystatin-c-with-heterogeneous-systems
#14
JOURNAL ARTICLE
Jie Zeng, Li Zhang, Jiangtao Zhang, Weiyan Zhou, Tianjiao Zhang, Jing Wang, Haijian Zhao, Chuanbao Zhang
OBJECTIVES: Except for the large bias of some measurement systems for serum cystatin C (CysC) measurements, unacceptable imprecision has been observed for the heterogenous system. This study analyzed the external quality assessment (EQA) results in 2018-2021 to provide an insight into the imprecision of CysC assays. METHODS: Five EQA samples were sent to participating laboratories every year. Participants were divided into reagent/calibrator-based peer groups, for which the robust mean of each sample and robust coefficient of variation (CV) were calculated by Algorithm A from ISO 13528...
March 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36866704/letter-to-the-editor-regarding-the-article-by-wayne-j-%C3%A2-dimech-et-al-time-to-address-quality-control-processes-applied-to-antibody-testing-for-infectious-diseases-clin-chem-lab-med-2023-61-2-%C3%A2-205-212
#15
LETTER
https://read.qxmd.com/read/36857146/multicenter-study-to-compare-the-diagnostic-performance-of-clia-vs-feia-transglutaminase-iga-assays-for-the-diagnosis-of-celiac-disease
#16
JOURNAL ARTICLE
Daan A R Castelijn, A H Leontine Mulder, Pieter van der Pol, Jolien C Hollander, Tietie Kuiper, Caroline Bijnens, Jan Damoiseaux, Hetty J Bontkes
OBJECTIVES: Celiac disease (CD) is an immune-mediated enteropathy driven by gluten intake. Presence of tTG-IgA antibodies is important for the diagnosis. However, different tTG-IgA assays are used and test performance may vary. Therefore, a retrospective multicenter study was performed to compare the diagnostic performance of three assays. METHODS: The fluorescence enzyme-linked immunoassay (FEIA) EliA Celikey IgA (Phadia), the chemiluminescence immunoassays (CLIA) h-tTG IgA QUANTA Flash® (Inova Diagnostics) and the anti-tTG ChLIA IgA (Euroimmun) were compared...
March 2, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36856054/short-term-biological-variation-of-plasma-uracil-in-a-caucasian-healthy-population
#17
JOURNAL ARTICLE
Anne Winther-Larsen, Anne Tranberg Madsen, Peter H Nissen, Elke Hoffmann-Lücke, Eva Greibe
OBJECTIVES: Plasma uracil is a new biomarker to assess the activity of dihydropyrimidine dehydrogenase before cancer treatment with fluoropyrimidine drugs. Knowledge on the biological variation of plasma uracil is important to assess the applicability of plasma uracil as a biomarker of drug tolerance and efficacy. METHODS: A total of 33 apparently healthy individuals were submitted to sequential blood draws for three days. On the second day, blood draws were performed every third hour for 12 h...
March 2, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36855921/a-new-door-to-a-different-world-opportunities-from-the-metaverse-and-the-raise-of-meta-medical-laboratories
#18
JOURNAL ARTICLE
Damien Gruson, Ronda Greaves, Pradeep Dabla, Sergio Bernardini, Bernard Gouget, Tuğba Kemaloğlu Öz
OBJECTIVES: In the digital age, the metaverse has emerged with impressive potential for many segments of society. The metaverse could be presented as a parallel dimension able to enhance the physical world as well as our actions and decisions in it with the objective to use a coalition between the natural and virtual worlds for value creation. Our aim was to elaborate on the impact of the metaverse on laboratory medicine. METHODS: Based on the available evidence, literature and reports, we analyzed the different perspectives of the metaverse on laboratory medicine and the needs for an efficient transition...
March 2, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36854392/analytical-performance-of-abbott-s-architect-and-alinity-tsh-receptor-antibody-trab-assays
#19
LETTER
Hani Choksi, Sheng Han Li, Maria Bhandari, Pow Lee Cheng, Xiao Yan Wang, Vathany Kulasingam
No abstract text is available yet for this article.
March 2, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
https://read.qxmd.com/read/36848496/cost-effectiveness-analysis-of-different-covid-19-screening-strategies-based-on-rapid-or-laboratory-based-sars-cov-2-antigen-testing
#20
LETTER
Laura Pighi, Brandon M Henry, Camilla Mattiuzzi, Simone De Nitto, Gian Luca Salvagno, Giuseppe Lippi
No abstract text is available yet for this article.
February 28, 2023: Clinical Chemistry and Laboratory Medicine: CCLM
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