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https://www.readbyqxmd.com/read/29346674/integrating-research-techniques-to-improve-quality-and-safety-in-the-preanalytical-phase
#1
Adolfo Romero, Juan Gómez-Salgado, José Andrés Domínguez-Gómez, Carlos Ruiz-Frutos
Background: Reducing errors in the preanalytical phase is difficult, which suggests the issue may be multidimensional. As such, qualitative research may be truly innovative in this context. Method: We carried out a descriptive study using a qualitative method incorporating 4 focus groups. Data analysis followed the principles of Grounded Theory. Results: We queried in each of the 4 focus groups collectively to identify weaknesses in the system...
January 13, 2018: Laboratory Medicine
https://www.readbyqxmd.com/read/29343532/clinical-laboratory-practice-recommendations-for-the-use-of-cardiac-troponin-in-acute-coronary-syndrome-expert-opinion-from-the-academy-of-the-american-association-for-clinical-chemistry-and-the-task-force-on-clinical-applications-of-cardiac-bio-markers-of
#2
Alan H B Wu, Robert H Christenson, Dina N Greene, Allan S Jaffe, Peter A Kavsak, Jordi Ordonez-Llanos, Fred S Apple
This document is an essential companion to the third iteration of the National Academy of Clinical Biochemistry [NACB,8 now the American Association for Clinical Chemistry (AACC) Academy] Laboratory Medicine Practice Guidelines (LMPG) on cardiac markers. The expert consensus recommendations were drafted in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine Task Force on Clinical Applications of Bio-Markers (IFCC TF-CB). We determined that there is sufficient clinical guidance on the use of cardiac troponin (cTn) testing from clinical practice groups...
January 17, 2018: Clinical Chemistry
https://www.readbyqxmd.com/read/29274328/preanalytical-and-analytical-challenges-in-gas-chromatographic-determination-of-cholesterol-synthesis-and-absorption-markers
#3
Tamara Gojkovic, Sandra Vladimirov, Vesna Spasojevic-Kalimanovska, Aleksandra Zeljkovic, Jelena Vekic, Jelena Arsenijevic, Ivana Djuricic, Sladjana Sobajic, Zorana Jelic-Ivanovic
INTRODUCTION: Cholesterol homeostasis disruption contributes to the development of different pathologies. Non-cholesterol sterols (NCSs) serve as cholesterol synthesis markers (desmosterol and lathosterol), and cholesterol absorption surrogate markers (campesterol, stigmasterol and β-sitosterol). The study aimed to resolve certain new pre-analytical and analytical problems and ensure a reliable and validated method. MATERIALS AND METHODS: Method optimization, validation and stability studies were executed in human serum and plasma...
December 20, 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/29258857/understanding-preanalytical-variables-and-their-effects-on-clinical-biomarkers-of-oncology-and-immunotherapy
#4
REVIEW
Lokesh Agrawal, Kelly B Engel, Sarah R Greytak, Helen M Moore
Identifying a suitable course of immunotherapy treatment for a given patient as well as monitoring treatment response is heavily reliant on biomarkers detected and quantified in blood and tissue biospecimens. Suboptimal or variable biospecimen collection, processing, and storage practices have the potential to alter clinically relevant biomarkers, including those used in cancer immunotherapy. In the present review, we summarize effects reported for immunologically relevant biomarkers and highlight preanalytical factors associated with specific analytical platforms and assays used to predict and gauge immunotherapy response...
December 16, 2017: Seminars in Cancer Biology
https://www.readbyqxmd.com/read/29244257/normal-reference-intervals-and-the-effects-of-sample-handling-on-dynamic-viscoelastic-coagulometry-sonoclot-in-healthy-adult-horses
#5
Camilla A Jamieson, Andrew S Hanzlicek, Mark E Payton, Todd C Holbrook
OBJECTIVE: To determine reference intervals and the effect of sample agitation and rest time on Sonoclot analysis in healthy adult horses. DESIGN: Original prospective study. SETTING: University veterinary medical teaching hospital. ANIMALS: Sixty healthy adult horses. INTERVENTIONS: Blood was collected for assessment of complete blood count, serum biochemical analysis, and Sonoclot analysis. MEASUREMENTS AND MAIN RESULTS: Horses were determined to be healthy based upon physical examination, CBC, and serum biochemistry analysis...
January 2018: Journal of Veterinary Emergency and Critical Care
https://www.readbyqxmd.com/read/29243660/lactate-blood-measurement-in-acute-cyanide-poisoning-effect-of-preanalytical-delay-and-hydroxocobalamin-uses-as-treatment
#6
Pascal Houzé, Marie Laforge, Frédéric J Baud
We quantify the impact of several variables including site of blood draw, delay in measurement, and use of the cyanide antidote hydroxocobalamin on detection of both normal (<2 mmol/L) and elevated (>6 mmol/L) human plasma lactate. An in vivo study assessed effects of venous or arterial origin of blood samples. Two in vitro studies assessed the effect of a 2 h delay in measuring plasma lactate concentrations, as well as the interference of low (100 μmol/L) and high (300 μmmol/L) plasma hydroxocobalamin concentrations on detecting normal and elevated levels of lactate...
December 15, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/29242895/comparison-of-laboratory-developed-tests-and-fda-approved-assays-for-braf-egfr-and-kras-testing
#7
Annette S Kim, Angela N Bartley, Julia A Bridge, Suzanne Kamel-Reid, Alexander J Lazar, Neal I Lindeman, Thomas A Long, Jason D Merker, Alex J Rai, David L Rimm, Paul G Rothberg, Patricia Vasalos, Joel T Moncur
Importance: The debate about the role of the Food and Drug Administration (FDA) in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing. This study provides data comparing the performance of LDTs and FDA-approved companion diagnostics (FDA-CDs) in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee. Objective: To compare the analytical performance of LDTs and FDA-CDs on well-characterized PT samples and to compare the practice characteristics of laboratories using these assays...
December 14, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/29226646/comparison-of-citrate-buffer-with-sodium-fluoride-as-additives-in-determining-glycemia
#8
Maria de Toro-Crespo, Jose M Maesa-Marquez, Victor Sanchez-Margalet, Concepcion Gonzalez-Rodriguez, Patricia Fernandez-Riejos
BACKGROUND: The objectives of this study are to compare the effect of sodium fluoride and citrate on the stability of glucose in samples maintained at room temperature up to three hours, and to assess the clinical impact in the O'Sullivan test results after changing the additives in the collecting tubes. METHODS: The selected population was pregnant women between the 24th and 28th week of gestation, who were at the health center to undergo the O'Sullivan test as part of the screening program for GDM (gestacional diabetes mellitus)...
November 1, 2017: Clinical Laboratory
https://www.readbyqxmd.com/read/29194040/effect-of-preanalytical-and-analytical-variables-on-the-clinical-utility-of-mean-platelet-volume
#9
Mauro Buttarello, Giacomo Mezzapelle, Mario Plebani
BACKGROUND: The study endpoint was to analyze the effect of preanalytical (time, temperature, anticoagulant) and analytical (imprecision, correlation between volume and platelet concentration) variables on mean platelet volume (MPV). A further aim was to calculate in an adult population the reference intervals using the Sysmex XE-5000 analyzer. A critical evaluation was also made of the clinical utility of these parameters. METHODS: Analyses of the above values were performed in duplicate in 170 healthy adults of both sexes: (1) within 30 min from collection, and (2) after 4 h...
December 1, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/29148824/biobanking-of-fresh-frozen-cancer-tissue-rna-is-stable-independent-of-tissue-type-with-less-than-1-hour-of-cold-ischemia
#10
Sang Yong Song, Jonghyun Jun, Miyeon Park, Seo Kyu Park, Wonju Choi, Kyunghee Park, Kee-Taek Jang, Myoyong Lee
BACKGROUND: The effects of preanalytical variables in tissue processing and storage periods on RNA quality of tissues have been well documented in each type of cancer. However, few studies have been performed on a comparative assessment of the impacts across different cancer tissues, even though it is well known that RNase activity is highly variable in various tissue types and RNase-rich tissues have been found to yield low-quality RNA. METHODS: We investigated the impacts of cold ischemia times and long-term storage on RNA integrity in various types of cancer tissue, which had been fresh-frozen and collected at the Samsung Medical Center Biobank...
November 17, 2017: Biopreservation and Biobanking
https://www.readbyqxmd.com/read/29146056/comparison-of-her2-status-determination-methods-in-her2-2-patients-manual-fluorescent-in-situ-hybridization-fish-vs-dual-silver-enhanced-in-situ-hybridization-sish
#11
Burcin Pehlivanoglu, Gurdeniz Serin, Levent Yeniay, Osman Zekioglu, Erhan Gokmen, Necmettin Ozdemir
HER2 amplification has been demonstrated in 15-25% of invasive breast carcinomas and can be assessed using immunohistochemical and in situ hybridization methods. Here, we compared the accuracy of dual SISH to manual FISH in HER2 (2+) breast carcinoma and evaluated the feasibility of dual SISH method in routine practice. Sixty HER2 (2+) consecutive tumor samples diagnosed between January 2009 and February 2013 were selected. Demographic, histological and immunohistochemical features and FISH results were recruited from patient records and compared to dual SISH results...
December 2017: Annals of Diagnostic Pathology
https://www.readbyqxmd.com/read/29144792/effect-of-blood-collection-tube-type-and-time-to-processing-on-the-enumeration-and-high-content-characterization-of-circulating-tumor-cells-using-the-high-definition-single-cell-assay
#12
Mariam Rodríguez-Lee, Anand Kolatkar, Madelyn McCormick, Angel D Dago, Jude Kendall, Nils Anders Carlsson, Kelly Bethel, Emily J Greenspan, Shelley E Hwang, Kathryn R Waitman, Jorge J Nieva, James Hicks, Peter Kuhn
CONTEXT: - As circulating tumor cell (CTC) assays gain clinical relevance, it is essential to address preanalytic variability and to develop standard operating procedures for sample handling in order to successfully implement genomically informed, precision health care. OBJECTIVE: - To evaluate the effects of blood collection tube (BCT) type and time-to-assay (TTA) on the enumeration and high-content characterization of CTCs by using the high-definition single-cell assay (HD-SCA)...
November 16, 2017: Archives of Pathology & Laboratory Medicine
https://www.readbyqxmd.com/read/29137972/circulating-tumoral-dna-preanalytical-validation-and-quality-control-in-a-diagnostic-laboratory
#13
Sergey Nikolaev, Laure Lemmens, Thibaud Koessler, Jean-Louis Blouin, Thierry Nouspikel
We present the results of our technical validation process in establishing the analysis of circulating tumor DNA (ctDNA) as a diagnostic tool. Like most cells in our body, tumor cells shed DNA in the blood flow. Analysis of ctDNA mutational content can provide invaluable information on the genetic makeup of a tumor, and assist oncologists in deciding on therapy, or in following residual disease. However, low absolute amounts of circulating DNA and low tumor fraction constitute formidable analytical challenges...
November 11, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/29115211/measurement-of-gastrointestinal-hormones
#14
Nicolai J Wewer Albrechtsen
Towards the end of the 20th century, the number of subjects with diabetes and obesity rose exponentially. The discoveries of insulin- and appetite-modulating chemical signals, including glucagon-like peptide-1 (GLP-1), secreted from the gastrointestinal system, led to development of a new group of drugs which now are being used for glucose-lowering therapy and weight loss. Understanding of the physiology of gut derived signals and their pathophysiologi-cal importance requires accurate measurements of their circulat-ing levels...
November 2017: Danish Medical Journal
https://www.readbyqxmd.com/read/29110777/the-use-of-cerebrospinal-fluid-in-biomarker-studies
#15
C E Teunissen, C Verheul, E A J Willemse
Cerebrospinal fluid (CSF) is an extremely useful matrix for biomarker research for several purposes, such as diagnosis, prognosis, monitoring, and identification of prominent leads in pathways of neurologic diseases. Such biomarkers can be identified based on a priori hypotheses around prominent protein changes, but also by applying -omics technologies. Proteomics is widely used, but metabolomics and transcriptomics are rapidly revealing their potential for CSF studies. The basis of such studies is the availability of high-quality biobanks...
2017: Handbook of Clinical Neurology
https://www.readbyqxmd.com/read/29106292/preanalytic-factors-associated-with-hemolysis-in-emergency-department-blood-samples
#16
Michael P Phelan, Edmunds Z Reineks, Jesse D Schold, Frederic M Hustey, Janelle Chamberlin, Gary W Procop
CONTEXT: - Hemolysis of emergency department blood samples is a common occurrence and has a negative impact on health care delivery. OBJECTIVES: - To determine the effect of preanalytic factors (straight stick, intravenous [IV] line, needle gauge, location of blood draw, syringe versus vacuum tube use, tourniquet time) on hemolysis in emergency department blood samples. DESIGN: - A single 65 000-visit emergency department's electronic health record was queried for emergency department potassium results and blood draw technique for all samples obtained in calendar year 2014, resulting in 54 531 potassium results...
November 6, 2017: Archives of Pathology & Laboratory Medicine
https://www.readbyqxmd.com/read/29084061/tissue-thickness-effects-on-immunohistochemical-staining-intensity-of-markers-of-cancer
#17
Adrienne S McCampbell, Varun Raghunathan, May Tom-Moy, Richard K Workman, Rick Haven, Amir Ben-Dor, Ole F Rasmussen, Lars Jacobsen, Martin Lindberg, N Alice Yamada, Carol Schembri
High-quality patient samples are required for reliable immunohistochemistry test outcomes that provide a significant benefit for patient care. Among the preanalytic variables in tissue handling, tissue thickness is thought to be easily controlled; however, whether the thickness of the tissue effects the staining intensity for antibody immunohistochemistry has not been quantitatively demonstrated. To investigate, we cut multiblock tissue sections of tonsil, liver, and kidney at 2, 4, 6, and 8 μm thicknesses...
October 27, 2017: Applied Immunohistochemistry & Molecular Morphology: AIMM
https://www.readbyqxmd.com/read/29084060/characterization-of-pd-l1-immunohistochemical-expression-in-cell-blocks-with-different-specimen-fixation-and-processing-methods
#18
Isaac E Lloyd, Wenhua Zhou, Benjamin L Witt, Barbara E Chadwick
Interpretative criteria for programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) have been largely based on data from formalin-fixed, paraffin-embedded tissues, despite the fact that cytologic specimens, especially cell blocks, are often the only or most readily available tissue for testing. Unlike biopsy specimens, however, cytology sample processing methods can vary markedly. The purpose of this study was to evaluate the effects of several common preanalytic variables on PD-L1 IHC. Two cell lines with strong expression of PD-L1 (H441) and no expression (MCF7) were cultured in vitro...
October 27, 2017: Applied Immunohistochemistry & Molecular Morphology: AIMM
https://www.readbyqxmd.com/read/29065378/clinical-relevance-of-molecular-diagnostics-in-gastrointestinal-gi-cancer-european-society-of-digestive-oncology-esdo-expert-discussion-and-recommendations-from-the-17th-european-society-for-medical-oncology-esmo-world-congress-on-gastrointestinal-cancer-barcelona
#19
REVIEW
Alexander Baraniskin, Jean-Luc Van Laethem, Lucjan Wyrwicz, Ulrich Guller, Harpreet S Wasan, Tamara Matysiak-Budnik, Thomas Gruenberger, Michel Ducreux, Fatima Carneiro, Eric Van Cutsem, Thomas Seufferlein, Wolff Schmiegel
BACKGROUND AND SCOPE: In the epoch of precision medicine and personalised oncology, which aims to deliver the right treatment to the right patient, molecular genetic biomarkers are a topic of growing interest. The aim of this expert discussion and position paper is to review the current status of various molecular tests for gastrointestinal (GI) cancers and especially considering their significance for the clinical routine use. METHODOLOGY: Opinion leaders and experts from diverse nationalities selected on scientific merit were asked to answer to a prepared set of questions about the current status of molecular diagnostics in different GI cancers...
November 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/29055897/t-cell-clonality-assessment-past-present-and-future
#20
REVIEW
Etienne Mahe, Tevor Pugh, Suzanne Kamel-Reid
T cell clonality testing has important clinical and research value, providing a specific and reproducible assessment of clonal diversity in T cell proliferations. Here we review the conceptual foundations of T cell clonality assays, including T cell ontogeny and T cell receptor structure and function; we also provide an introduction to T cell receptor genomics and the concept of the T cell clonotype. This is followed by a review of historical and current methods by which T cell clonality may be assayed, including current assay limitations...
October 21, 2017: Journal of Clinical Pathology
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