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Deepali Jain, Sinchita Roy-Chowdhuri
CONTEXT: - There has been a paradigm shift in the understanding of molecular pathogenesis of lung cancer. A number of oncogenic drivers have been identified in non-small cell lung carcinoma, such as the epidermal growth factor receptor ( EGFR) mutation and anaplastic lymphoma kinase ( ALK) gene rearrangement. Because of the clinical presentation at an advanced stage of disease in non-small cell lung carcinoma patients, the use of minimally invasive techniques is preferred to obtain a tumor sample for diagnosis...
March 16, 2018: Archives of Pathology & Laboratory Medicine
Antonio La Gioia, Maurizio Fumi, Fabiana Fiorini, Paola Pezzati, Fiamma Balboni, Maria Bombara, Alessandra Marini, Ylenia Pancione, Leonardo Solarino, Elisa Marchese, Silvia Sale, Vincenzo Rocco, Marcello Fiorini
AIMS: The presence of cold agglutinin in blood samples can cause a spontaneous agglutination of red blood cells (RBCs) when low temperature occurs. This phenomenon causes a spurious lowering of RBC count on the automated haematological analysers that are detected by incongruous values (≥370 g/L) of the mean cellular haemoglobi concentration (MCHC). A preheating at 37°C can remove the RBC agglutination generally resulting in a reliable count. It has been reported that the same result can be reached by using the optical reticulocyte (RET) channel of Sysmex analysers where the RBC count is not influenced by the presence of cold agglutinin...
March 13, 2018: Journal of Clinical Pathology
Müjgan Ercan, Esra Fırat Oğuz, Emiş Deniz Akbulut, Mustafa Yilmaz, Turan Turhan
BACKGROUND: Selection and verification of blood collection tubes is an important preanalytical issue in clinical laboratories. Today, gel tubes are commonly used with many advantages, although they are known to cause interference in immunoassay methods. In this study, we aimed to compare SSTs of two different suppliers (Ayset clot activator & Gel and Becton Dickinson (BD) Vacutainer SST II advance) with reference tubes and evaluate the effect of storage time in terms of commonly used endocrine tests such as thyroid-stimulating hormone (TSH), free thyroxine (fT4), and free triiodothyronine (fT3)...
March 7, 2018: Journal of Clinical Laboratory Analysis
Giuseppe Lippi, Janne Cadamuro, Alexander von Meyer, Ana-Maria Simundic
No abstract text is available yet for this article.
March 3, 2018: Clinical Biochemistry
Jason D Merker, Geoffrey R Oxnard, Carolyn Compton, Maximilian Diehn, Patricia Hurley, Alexander J Lazar, Neal Lindeman, Christina M Lockwood, Alex J Rai, Richard L Schilsky, Apostolia M Tsimberidou, Patricia Vasalos, Brooke L Billman, Thomas K Oliver, Suanna S Bruinooge, Daniel F Hayes, Nicholas C Turner
PURPOSE: - Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from the American Society of Clinical Oncology and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. METHODS: - An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including preanalytical variables, analytical validity, interpretation and reporting, and clinical validity and utility...
March 5, 2018: Archives of Pathology & Laboratory Medicine
Jennifer L Johns, Kaitlin A Moorhead, Jing Hu, Roberta C Moorhead
Clinical pathology testing of rodents is often challenging due to insufficient sample volume. One solution in clinical veterinary and exploratory research environments is dilution of samples prior to analysis. However, published information on the impact of preanalytical sample dilution on rodent biochemical data is incomplete. The objective of this study was to evaluate the effects of preanalytical sample dilution on biochemical analysis of mouse and rat serum samples utilizing the Siemens Dimension Xpand Plus...
2018: Frontiers in Veterinary Science
Manish Kumar, Yashmin Choudhury, Sankar Kumar Ghosh, Rosy Mondal
The conventional method of measuring biomarkers in malignant tissue samples has already given subversive growth in cancer diagnosis, prognosis, and therapy selection. However, the regression and heterogeneity associated with tumor tissue biopsy have urged for the development of an alternative approach. Considering the limitations, cell-free DNA has emerged as a surrogate alternative, facilitating preoperative chemoradiotherapy (p < 0.0001) treatment response in rectal cancer and detection of biomarker in lung cancer...
February 2018: Tumour Biology: the Journal of the International Society for Oncodevelopmental Biology and Medicine
Amalija Bunjevac, Nora Nikolac Gabaj, Marijana Miler, Anita Horvat
Introduction: Laboratories often modify procedures recommended by the European Urinalysis Guidelines for urine sediment analysis. The aim of this study was to compare the recommended protocol with our routine laboratory procedure and to evaluate the possible impact of modifications in the relative centrifugal force, type of tube, method of supernatant aspiration and urine volume on patient's results. Material and methods: Firstly, relative centrifugal force was investigated using 20 pairs of samples examined after centrifugation at 400xg and 1358xg...
February 15, 2018: Biochemia Medica: časopis Hrvatskoga Društva Medicinskih Biokemičara
Thaer Khoury
Objectives: The gold standard of examining breast biomarkers, including estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2)/Ki-67, is to perform these assays on formalin-fixed, paraffin-embedded tissue. However, preanalytical variables may confound these assays. One of these factors is delay to formalin fixation (DFF). The purpose of this review is to evaluate each study that investigated the effect of DFF on breast biomarkers and other molecules...
February 19, 2018: American Journal of Clinical Pathology
Jeremy P Koelmel, Christina M Jones, Candice Z Ulmer, Timothy J Garrett, Richard A Yost, Tracey B Schock, John A Bowden
AIM: To confidently determine lipid-based biomarkers, it is important to minimize variation introduced during preanalytical steps. We evaluated reducing variation associated with lipid measurements in invertebrate sentinel species using a state-of-the-art heat treatment technique. MATERIALS AND METHODS: Earthworms (Eisenia fetida), house crickets (Acheta domestica) and ghost shrimp (Palaemonetes paludosus) were euthanized either by flash freezing or heat treatment...
February 16, 2018: Bioanalysis
C H Miller
Inhibitors are antibodies directed against haemophilia treatment products which interfere with their function. Factor VIII (FVIII) inhibitors in haemophilia A and factor IX (FIX) inhibitors in haemophilia B are significant clinically when they require a change in a patient's treatment regimen. Their persistence may increase morbidity and mortality. Multiple laboratory tests are now available for detecting and understanding inhibitors in haemophilia. Inhibitors are traditionally measured by their interference in clotting or chromogenic factor assays...
February 15, 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
Newton A C S Wong, Fernanda Amary, Rachel Butler, Richard Byers, David Gonzalez, Harry R Haynes, Mohammad Ilyas, Manuel Salto-Tellez, Philippe Taniere
The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma...
February 8, 2018: Journal of Clinical Pathology
Vladimira Rimac, Ivana Lapic, Kresimir Kules, Dunja Rogic, Marijana Miler
Objective: Autovalidation algorithm should be properly designed with clearly defined criteria and any data that do not meet the criteria, must be reviewed and manually validated. The aim was to define the rules for autovalidation in our laboratory information system (LIS), and validate the algorithm prior to its implementation in routine laboratory work. Methods: Autovalidation was implemented for all routine serum biochemistry tests. The algorithm included analytical measurement ranges (AMR), delta check, critical values, serum indices and all preanalytical and analytical flags from the analyzer...
February 8, 2018: Laboratory Medicine
Janne Cadamuro, Martin Gaksch, Helmut Wiedemann, Giuseppe Lippi, Alexander von Meyer, Astrid Pertersmann, Simon Auer, Cornelia Mrazek, Ulrike Kipman, Thomas K Felder, Hannes Oberkofler, Elisabeth Haschke-Becher
BACKGROUND: Inappropriate utilization of laboratory resources is an increasing concern especially in high-throughput facilities. Until now, no reliable information has been published addressing to which extent laboratory results are actually used for clinical decision-making. Therefore, we aimed to close this gap using a novel retrospective approach including a survey of clinicians and nurses. METHODS: We retrospectively evaluated the number of re-orders for potassium (K), lactate dehydrogenase (LD), aspartate-aminotransferase (AST), activated partial thromboplastin-time (APTT) and prothrombin-time/INR (PT/INR), after the initial order had to be cancelled due to preanalytical non-conformities...
February 2, 2018: Clinical Biochemistry
Samuel Vasikaran
An imbalance between bone formation and bone resorption is a factor in the development of osteoporosis. Bone turnover markers (BTM) are useful in assessing bone remodeling at the cellular level. Measurement of BTM is useful for assessing bone turnover and therefore fracture risk as well as for monitoring response to treatment response. This paper describes the steps that have been taken so far and the ongoing work to harmonize the total testing process for the assessment of bone turnover in osteoporosis internationally and collaboratively between the clinical and laboratory professions...
January 30, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Fay Betsou, Roberto Bilbao, Jamie Case, Rodrigo Chuaqui, Judith Ann Clements, Yvonne De Souza, Annemieke De Wilde, Jörg Geiger, William Grizzle, Fiorella Guadagni, Elaine Gunter, Stacey Heil, Michael Kiehntopf, Iren Koppandi, Sabine Lehmann, Loes Linsen, Jacqueline Mackenzie-Dodds, Rocio Aguilar Quesada, Riad Tebbakha, Teresa Selander, Katheryn Shea, Mark Sobel, Stella Somiari, Demetri Spyropoulos, Mars Stone, Gunnel Tybring, Klara Valyi-Nagy, Lalita Wadhwa
No abstract text is available yet for this article.
January 29, 2018: Biopreservation and Biobanking
Romy M Heilmann, Niels Grützner, Stefanie Handl, Jan S Suchodolski, Jörg M Steiner
BACKGROUND: Calprotectin is a marker of inflammatory disorders in people, and serum and fecal calprotectin were shown to be increased in dogs with gastrointestinal inflammation. Biomarkers of gastrointestinal inflammation are currently lacking in cats. OBJECTIVES: The purpose of the study was to analytically validate the canine calprotectin radioimmunoassay for quantification of calprotectin in feline specimens. METHODS: The immunoassay was analytically validated by determining assay working range, dilutional parallelism, spiking recovery, and intra- and inter-assay variability...
January 29, 2018: Veterinary Clinical Pathology
Marilyn B Nourse, Kate Engel, Samartha G Anekal, Jocelyn A Bailey, Pradeep Bhatta, Devayani P Bhave, Shekar Chandrasekaran, Yutao Chen, Steven Chow, Ushati Das, Erez Galil, Xinwei Gong, Steven F Gessert, Kevin D Ha, Ran Hu, Laura Hyland, Arvind Jammalamadaka, Karthik Jayasurya, Timothy M Kemp, Andrew N Kim, Lucie S Lee, Yang Lily Liu, Alphonso Nguyen, Jared O'Leary, Chinmay H Pangarkar, Paul J Patel, Ken Quon, Pradeep L Ramachandran, Amy R Rappaport, Joy Roy, Jerald F Sapida, Nikolay V Sergeev, Chandan Shee, Renuka Shenoy, Sharada Sivaraman, Bernardo Sosa-Padilla, Lorraine Tran, Amanda Trent, Thomas C Waggoner, Dariusz Wodziak, Amy Yuan, Peter Zhao, Daniel L Young, Channing R Robertson, Elizabeth A Holmes
The ability to perform laboratory testing near the patient and with smaller blood volumes would benefit patients and physicians alike. We describe our design of a miniaturized clinical laboratory system with three components: a hardware platform (ie, the miniLab) that performs preanalytical and analytical processing steps using miniaturized sample manipulation and detection modules, an assay-configurable cartridge that provides consumable materials and assay reagents, and a server that communicates bidirectionally with the miniLab to manage assay-specific protocols and analyze, store, and report results (i...
January 2018: Bioengineering & Translational Medicine
Giuseppe Lippi, Janne Cadamuro, Alexander von Meyer, Ana-Maria Simundic
We suggest here a pragmatic approach for managing results of clinical chemistry testing in hemolyzed samples collected from adults/older children, attempting to balance the need to produce quality laboratory data with clinical urgency of releasing test results. Automatic measurement of the hemolysis index (H-index) in serum or plasma is highly advisable, whilst low-quality assessment of this test remains less good than a visual inspection. Regarding its practical use, when the H-index value does not generate an analytically significant bias, results can be released, whilst when the value is associated with analyte variation in a range between analytically and clinically significant bias (i...
January 26, 2018: Clinical Chemistry and Laboratory Medicine: CCLM
Sweta Kulkarni, R Ramesh, A R Srinivasan, C R Wilma Delphine Silvia
Preanalytical steps are the major sources of error in clinical laboratory. The analytical errors can be corrected by quality control procedures but there is a need for stringent quality checks in preanalytical area as these processes are done outside the laboratory. Sigma value depicts the performance of laboratory and its quality measures. Hence in the present study six sigma and Pareto principle was applied to preanalytical quality indicators to evaluate the clinical biochemistry laboratory performance. This observational study was carried out for a period of 1 year from November 2015-2016...
January 2018: Indian Journal of Clinical Biochemistry: IJCB
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