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Clinical Chemistry

Eszter Lázár-Molnár, Julio C Delgado
BACKGROUND: Monoclonal antibody therapeutics (MATs) represent a rapidly expanding class of biological drugs used to treat a variety of diseases. The widespread use of MATs increasingly affects clinical laboratory medicine. CONTENT: This review provides an overview of MATs currently approved for clinical use in the US, starting from basic biology of antibodies to the engineering, pharmacokinetic and pharmacodynamic properties, nomenclature, and production of MATs...
October 30, 2018: Clinical Chemistry
Noemi Vidal-Folch, Dimitar Gavrilov, Kimiyo Raymond, Piero Rinaldo, Silvia Tortorelli, Dietrich Matern, Devin Oglesbee
BACKGROUND: Spinal muscular atrophy (SMA) is a progressive neuromuscular disorder with neuronal degeneration leading to muscular atrophy and respiratory failure. SMA is frequently caused by homozygous deletions that include exon 7 of the survival motor neuron gene SMN1 , and its clinical course is influenced by the copy number of a nearby 5q SMN1 paralog, SMN2 . Multiple ligation probe amplification (MLPA) and real-time quantitative PCR (qPCR) can detect SMN1 deletions. Yet, qPCR needs normalization or standard curves, and MLPA demands DNA concentrations above those obtainable from dried blood spots (DBSs)...
October 23, 2018: Clinical Chemistry
Joel D Smith, Scott Wilson, Hans G Schneider
BACKGROUND: Clinical laboratories measure total calcium and adjust for albumin concentrations to predict calcium status. We compared total and adjusted calcium (Adj-Ca) with ionized calcium (Ca2+ ) for correct assignment of calcium status. The effect of restriction of Adj-Ca reporting in patients with hypoalbuminemia was determined on the basis of frequency of misclassifications. METHODS: Extraction of laboratory results was performed for 24 months. Adj-Ca was calculated from a modified Payne formula...
October 23, 2018: Clinical Chemistry
Timothy D Minogue, Jeffrey W Koehler, Christopher P Stefan, Turner A Conrad
BACKGROUND: Next-generation sequencing (NGS) is revolutionizing a variety of molecular biology fields including bioforensics, biosurveillance, and infectious disease diagnostics. For pathogen detection, the ability to sequence all nucleic acids in a sample allows near limitless multiplexability, free from a priori knowledge regarding an etiologic agent as is typically required for targeted molecular assays such as real-time PCR. Furthermore, sequencing capabilities can generate in depth genomic information, allowing detailed molecular epidemiological studies and bioforensics analysis, which is critical for source agent identification in a biothreat outbreak...
October 23, 2018: Clinical Chemistry
Pedrum Mohammadi-Shemirani, Jennifer Sjaarda, Hertzel C Gerstein, Darin J Treleaven, Michael Walsh, Johannes F Mann, Matthew J McQueen, Sibylle Hess, Guillaume Paré
BACKGROUND: Identifying markers of chronic kidney disease (CKD) that occur early in the disease process and are specific to loss of kidney function rather than other underlying causes of disease may allow earlier, more accurate identification of patients who will develop CKD. We therefore sought to identify diagnostic blood markers of early CKD that are caused by loss of kidney function by using an innovative "reverse Mendelian randomization" (MR) approach. METHODS: We applied this technique to genetic and biomarker data from 4147 participants in the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial, all with known type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance...
October 18, 2018: Clinical Chemistry
Nader Rifai
No abstract text is available yet for this article.
October 16, 2018: Clinical Chemistry
Cees B M Oudejans
No abstract text is available yet for this article.
October 16, 2018: Clinical Chemistry
Asma Hatoum-Aslan
No abstract text is available yet for this article.
October 15, 2018: Clinical Chemistry
Julie L Hejl, Mia K Grand, Volkert Siersma, Jens P Goetze, Niels de Fine Olivarius, Christen L Andersen, Bent Lind
BACKGROUND: Measurement of B-type natriuretic peptide (BNP) in plasma may have its greatest potential in primary care, as general practitioners need to rapidly identify patients who warrant further medical review. The aim of the present study was to examine the prognostic information of BNP measurement on all-cause mortality in a large Danish primary care cohort. METHODS: This study covered a cohort of Danish primary care patients (n = 61665) with a median follow-up period of 4...
October 15, 2018: Clinical Chemistry
Paul J Jannetto, Anders Helander, Uttam Garg, Gregory C Janis, Bruce Goldberger, Hemamalini Ketha
BACKGROUND: Since 2013, an unprecedented surge in fentanyl overdose deaths has been caused by heroin laced with illicitly produced fentanyl and/or fentanyl analogs (FAs) sold as heroin. The US Drug Enforcement Agency's National Forensic Laboratory Information System reported a >300% increase in fentanyl encounters from 4697 in 2014 to 14440 in 2015. In 2015, the CDC reported 9580 deaths caused by synthetic opioids, primarily fentanyl, a 72% increase from 2014. The European Monitoring Centre for Drugs and Drug Addiction has also encountered several new FAs in the heroin supply...
October 10, 2018: Clinical Chemistry
Armando Tripodi, Veena Chantarangkul, Cristina Novembrino, Flora Peyvandi
BACKGROUND: Until recently, clinical laboratories have monitored hemophilia treatment by measuring coagulation factors before/after infusion of human-derived or recombinant factors. Substantial changes are expected in the near future based on new therapeutic approaches that have been or are being developed. CONTENT: Hemophilia treatment includes replacement therapy with human-derived/recombinant factors or treatment with bypassing agents for patients without or with inhibitors, respectively...
October 3, 2018: Clinical Chemistry
Emily G Spencer, Eric J Topol
No abstract text is available yet for this article.
October 1, 2018: Clinical Chemistry
Andrew J Vickers
No abstract text is available yet for this article.
October 1, 2018: Clinical Chemistry
Mariana Fitarelli-Kiehl, Fangyan Yu, Ravina Ashtaputre, Ka Wai Leong, Ioannis Ladas, Julianna Supplee, Cloud Paweletz, Devarati Mitra, Jonathan D Schoenfeld, Sareh Parangi, G Mike Makrigiorgos
BACKGROUND: Although interest in droplet-digital PCR technology (ddPCR) for cell-free circulating DNA (cfDNA) analysis is burgeoning, the technology is compromised by subsampling errors and the few clinical targets that can be analyzed from limited input DNA. The paucity of starting material acts as a "glass ceiling" in liquid biopsies because, irrespective how analytically sensitive ddPCR techniques are, detection limits cannot be improved past DNA input limitations. METHODS: We applied denaturation-enhanced ddPCR (dddPCR) using fragmented genomic DNA (gDNA) with defined mutations...
October 1, 2018: Clinical Chemistry
Felix Neumann, Iván Hernández-Neuta, Malin Grabbe, Narayanan Madaboosi, Jan Albert, Mats Nilsson
BACKGROUND: Influenza remains a constant threat worldwide, and WHO estimates that it affects 5% to 15% of the global population each season, with an associated 3 to 5 million severe cases and up to 500000 deaths. To limit the morbidity and the economic burden of influenza, improved diagnostic assays are needed. METHODS: We developed a multiplexed assay for the detection and subtyping of seasonal influenza based on padlock probes and rolling circle amplification...
September 26, 2018: Clinical Chemistry
Jean-Paul Salameh, Matthew D F McInnes, David Moher, Brett D Thombs, Trevor A McGrath, Robert Frank, Anahita Dehmoobad Sharifabadi, Noémie Kraaijpoel, Brooke Levis, Patrick M Bossuyt
BACKGROUND: We evaluated the completeness of reporting of diagnostic test accuracy (DTA) systematic reviews using the recently developed Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA)-DTA guidelines. METHODS: MEDLINE® was searched for DTA systematic reviews published October 2017 to January 2018. The search time span was modulated to reach the desired sample size of 100 systematic reviews. Reporting on a per-item basis using PRISMA-DTA was evaluated...
September 20, 2018: Clinical Chemistry
Dragana Milosevic, John R Mills, Michael B Campion, Noemi Vidal Folch, Jesse S Voss, Kevin C Halling, W Edward Highsmith, Minetta C Liu, Benjamin R Kipp, Stefan K G Grebe
BACKGROUND: Droplet digital PCR (ddPCR) is an emerging technology for quantitative cell-free DNA oncology applications. However, assay performance criteria must be established in a standardized manner to harness this potential. We reasoned that standard protocols used in clinical chemistry assay validation should be able to fill this need. METHODS: We validated KRAS , EGFR , and BRAF quantitative ddPCR assays based on the Clinical Laboratory Improvement Act regulations for laboratory-developed tests in clinical chemistry and the matching Clinical and Laboratory Standards Institute guidelines...
September 20, 2018: Clinical Chemistry
Yingyu Liu, Karen Ka-Wing Wong, Elaine Yee-Ling Ko, Xiaoyan Chen, Jin Huang, Stephen Kwok-Wing Tsui, Tin Chiu Li, Stephen Siu-Chung Chim
BACKGROUND: A recent study has reported that the microbiota in endometrial fluid of patients receiving in vitro fertilization and embryo transfer (IVF-ET) may predict implantation and pregnancy rates. However, studies are lacking that simultaneously compare the microbiota between endometrial fluid and tissue samples. Whether the microbiota composition in endometrial fluid reflects that in the endometrial tissue remains unclear. METHODS: We systematically profiled the microbiota in endometrial fluid and tissue samples of IVF-ET patients using massively parallel sequencing...
September 20, 2018: Clinical Chemistry
Rongrong Huang, Sara Cathey, Laura Pollard, Tim Wood
BACKGROUND: The glycoproteinoses are a subgroup of lysosomal storage diseases (LSDs) resulting from impaired degradation of N-linked oligosaccharide side chains of glycoproteins, which are commonly screened by detecting the accumulated free oligosaccharides (FOSs) in urine via thin layer chromatography (TLC). The traditional TLC method suffers from limited analytical sensitivity and specificity and lacks quantification capability. Therefore, we developed an analytically sensitive and relatively specific assay using ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for urinary FOS analysis and validated its use for urine screening of glycoproteinoses and other LSDs...
September 10, 2018: Clinical Chemistry
Glenn E Palomaki, James N Martin, S Ananth Karumanchi, Liona C Poon
No abstract text is available yet for this article.
September 10, 2018: Clinical Chemistry
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