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Preanalytical

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https://www.readbyqxmd.com/read/28231060/improving-quality-in-the-preanalytical-phase-through-innovation-on-behalf-of-the-european-federation-for-clinical-chemistry-and-laboratory-medicine-eflm-working-group-for-preanalytical-phase-wg-pre
#1
Giuseppe Lippi, Geoffrey S Baird, Giuseppe Banfi, Karin Bölenius, Janne Cadamuro, Stephen Church, Michael P Cornes, Anna Dacey, Antoine Guillon, Georg Hoffmann, Mads Nybo, Lakdasa Devananda Premawardhana, María Salinas, Sverre Sandberg, Robbert Slingerland, Ana Stankovic, Sylte Marit Sverresdotter, Pieter Vermeersch, Ana-Maria Simundic
It is now undeniable that laboratory testing is vital for the diagnosis, prognostication and therapeutic monitoring of human disease. Despite the many advances made for achieving a high degree of quality and safety in the analytical part of diagnostic testing, many hurdles in the total testing process remain, especially in the preanalytical phase ranging from test ordering to obtaining and managing the biological specimens. The Working Group for the Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has planned many activities aimed at mitigating the vulnerability of the preanalytical phase, including the organization of three European meetings in the past 7 years...
February 23, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28222302/how-to-handle-adsorption-of-cerebrospinal-fluid-amyloid-%C3%AE-1-42-in-laboratory-practice-identifying-problematic-handlings-and-resolving-the-issue-by-use-of-the-a%C3%AE-42-a%C3%AE-40-ratio
#2
Eline Willemse, Kees van Uffelen, Britta Brix, Sebastiaan Engelborghs, Hugo Vanderstichele, Charlotte Teunissen
INTRODUCTION: We aimed to investigate factors defining amyloid-β (1-42) (Aβ1-42) adsorption during preanalytical workup of cerebrospinal fluid (CSF). METHODS: CSF was transferred to new tubes ≤4 times. Variables tested were different polypropylene tube brands, volumes, CSF Aβ1-42 concentrations, incubation times, pipettes, vortex intensities, and other CSF proteins, including hyperphosphorylated tau and IL-1RAcP. An enquiry assessed the number of transfers in current practice...
February 18, 2017: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
https://www.readbyqxmd.com/read/28207411/reporting-altered-test-results-in-hemolyzed-samples-is-the-cure-worse-than-the-disease
#3
Giuseppe Lippi, Gianfranco Cervellin, Mario Plebani
The management of laboratory data in unsuitable (hemolyzed) samples remains an almost unresolved dilemma. Whether or not laboratory test results obtained by measuring unsuitable specimens should be made available to the clinicians has been the matter of fierce debates over the past decades. Recently, an intriguing alternative to suppressing test results and recollecting the specimen has been put forward, entailing the definition and implementation of specific algorithms that would finally allow reporting a preanalytically altered laboratory value within a specific comment about its uncertainty of measurement...
February 16, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28207409/to-report-or-not-to-report-a-proposal-on-how-to-deal-with-altered-test-results-in-hemolytic-samples
#4
Janne Cadamuro, Cornelia Mrazek, Elisabeth Haschke-Becher, Sverre Sandberg
Preanalytically altered test results are a challenge every laboratory has to face. The release of such results may be to the harm of the patient by triggering wrong clinical decision making in monitoring or treatment. On the other hand, their deletion also might be to the harm of the patient by delaying the time to decision making as the exact value sometimes is not even necessary but rather an answer to the question "Is it raised or lowered". Based on this dilemma and forced to produce laboratory values without any clinical information on the respective patient, laboratories have developed their own preferred way on how to deal with preanalytically altered test results...
February 16, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28187031/x-ray-of-excised-cancerous-breast-tissue-does-not-affect-clinical-biomarker-expression
#5
Isaac E Lloyd, Alana L Welm, Yoko DeRose, Leigh A Neumayer, Jessica L Kohan, Elisabeth M Malmberg, Mohamed E Salama, Rachel E Factor
CONTEXT: College of American Pathologists (CAP) and the American Society of Clinical Oncology have emphasized the need to reduce preanalytic variables for evaluating predictive biomarker expression in breast cancer. Postoperative x-ray of excised breast tissue is commonplace, yet is a variable that has not been investigated previously. We asked whether such radiation affects expression of relevant biomarkers. DESIGN: A previous study found that human breast cancers grown in mice demonstrate the same immunohistochemical and molecular profiles as the original tumors...
February 9, 2017: Applied Immunohistochemistry & Molecular Morphology: AIMM
https://www.readbyqxmd.com/read/28178899/recognizing-and-reducing-analytical-errors-and-sources-of-variation-in-clinical-pathology-data-in-safety-assessment-studies
#6
A E Schultze, A R Irizarry
Veterinary clinical pathologists are well positioned via education and training to assist in investigations of unexpected results or increased variation in clinical pathology data. Errors in testing and unexpected variability in clinical pathology data are sometimes referred to as "laboratory errors." These alterations may occur in the preanalytical, analytical, or postanalytical phases of studies. Most of the errors or variability in clinical pathology data occur in the preanalytical or postanalytical phases...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28178898/deciphering-sources-of-variability-in-clinical-pathology-it-s-not-just-about-the-numbers
#7
Nancy E Everds
Preanalytical variables can have significant impacts on clinical pathology parameters evaluated during the conduct of a nonclinical safety or toxicity study. These preanalytical variables can be controlled by careful attention to factors such as animal dietary status (diet composition, fasted, and fed state), restraint and anesthesia, intercurrent procedures, timing of clinical pathology collections, and proficiency of animal technicians. The impact of preanalytical variables on test results can be significant enough to result in difficult interpretations and/or regulatory questions or can obfuscate the effects of a test article...
February 2017: Toxicologic Pathology
https://www.readbyqxmd.com/read/28164516/hil-interferences-on-three-hemostasis-analyzers-and-contribution-of-a-preanalytical-module-for-routine-coagulation-assays
#8
Carole Nagant, Laurence Rozen, Anne Demulder
BACKGROUND: Preanalytical issues are a major part of routine coagulation laboratory errors. Automation in detection of preanalytical problems, including hemolysis, icterus and lipemia (HIL), improper tube fill volume, and undue clotting, has recently been implemented on specific hemostasis instruments. The aim of this study was to assess the added value of a new preanalytical module integrated into hemostasis analyzers compared to visual inspection of samples. METHODS: The detection of preanalytical issues was performed by visual or manual inspection of the samples and by the new preanalytical module integrated on the ACL TOP 550...
October 1, 2016: Clinical Laboratory
https://www.readbyqxmd.com/read/28164307/how-to-quantify-microparticles-in-rbcs-a-validated-flow-cytometry-method-allows-the-detection-of-an-increase-in-microparticles-during-storage
#9
Clémentine Gamonet, Guillaume Mourey, Sophie Aupet, Sabéha Biichle, Régis Petitjean, Chrystelle Vidal, Aurore Pugin, Christian Naegelen, Pierre Tiberghien, Pascal Morel, Fanny Angelot-Delettre, Estelle Seilles, Philippe Saas, Laurent Bardiaux, Francine Garnache-Ottou
BACKGROUND: The procoagulant and proinflammatory microparticles (MPs) released during storage of packed red blood cells (pRBCs) can potentially modify transfusion benefits. A robust method to quantify MPs in pRBCs is needed to evaluate their impact in clinical trials. STUDY DESIGN AND METHODS: The objective was to validate the preanalytic conditions required to prepare pRBC supernatant as well as a method to quantify and evaluate MP variations over 42 days of pRBC storage...
February 5, 2017: Transfusion
https://www.readbyqxmd.com/read/28163015/a-pragmatic-approach-to-sample-acceptance-and-rejection
#10
Janne Cadamuro, Ana-Maria Simundic, Eva Ajzner, Sverre Sandberg
Sample rejection due to preanalytical errors is very common in many medical laboratories worldwide, though the decision when and how to refrain from analyzing such samples is handled very heterogeneously. As a rational, it is mostly stated that it is done to prevent the patient from being harmed by wrong medical decisions based on such values. But when thinking of the consequences of laboratory results instead of their quality being important per se, the rejection of preanalytically altered samples might be harming the patient by the need of re-collection and timely delay...
February 2, 2017: Clinical Biochemistry
https://www.readbyqxmd.com/read/28125403/innovative-software-for-recording-preanalytical-errors-in-accord-with-the-ifcc-quality-indicators
#11
Giuseppe Lippi, Laura Sciacovelli, Ana-Maria Simundic, Mario Plebani
No abstract text is available yet for this article.
March 1, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28122725/optimal-fixation-conditions-and-dna-extraction-methods-for-mlpa-analysis-on-ffpe-tissue-derived-dna
#12
Lilit Atanesyan, Maryvonne J Steenkamer, Anja Horstman, Cathy B Moelans, Jan P Schouten, Suvi P Savola
OBJECTIVES: Molecular genetic analysis of formalin-fixed, paraffin-embedded (FFPE) tissues is of great importance both for research and diagnostics. Multiplex ligation-dependent probe amplification (MLPA) is a widely used technique for gene copy number determination, and it has been successfully used for FFPE tissue-extracted DNA analysis. However, there have been no studies addressing the effect of tissue fixation procedures and DNA extraction methods on MLPA. This study therefore focuses on selecting optimal preanalytic conditions such as FFPE tissue preparation conditions and DNA extraction methods...
January 24, 2017: American Journal of Clinical Pathology
https://www.readbyqxmd.com/read/28101312/cryoglobulin-test-and-cryoglobulinemia-hepatitis-c-virus-related
#13
REVIEW
Francesca Gulli, Stefano Angelo Santini, Cecilia Napodano, Patrizia Bottoni, Krizia Pocino, Gian Ludovico Rapaccini, Umberto Basile
Cryoglobulins are immunoglobulins that precipitate in serum at temperatures below 37°C and resolubilize upon warming. The clinical syndrome of cryoglobulinemia usually includes purpura, weakness, and arthralgia, but the underlying disease may also contribute other symptoms. Blood samples for cryoglobulin are collected, transported, clotted and spun at 37°C, before the precipitate is allowed to form when serum is stored at 4°C in a Wintrobe tube for at least seven days. The most critical and confounding factor affecting the cryoglobulin test is when the preanalytical phase is not fully completed at 37°C...
2017: Mediterranean Journal of Hematology and Infectious Diseases
https://www.readbyqxmd.com/read/28089353/cerebrospinal-fluid-mitochondrial-dna-in-the-alzheimer-s-disease-continuum
#14
Laura Cervera-Carles, Daniel Alcolea, Ainara Estanga, Mirian Ecay-Torres, Andrea Izagirre, Montserrat Clerigué, Maite García-Sebastián, Jorge Villanúa, Clàudia Escalas, Rafael Blesa, Pablo Martínez-Lage, Alberto Lleó, Juan Fortea, Jordi Clarimón
Low levels of cell-free mitochondrial DNA (mtDNA) in the cerebrospinal fluid (CSF) of Alzheimer's disease (AD) patients have been identified and proposed as a novel biomarker for the disease. The lack of validation studies of previous results prompted us to replicate this finding in a comprehensive series of patients and controls. We applied droplet digital polymerase chain reaction in CSF specimens from 124 patients representing the AD spectrum and 140 neurologically healthy controls. The following preanalytical and analytical parameters were evaluated: the effect of freeze-thaw cycles on mtDNA, the linearity of mtDNA load across serial dilutions, and the mtDNA levels in the diagnostic groups...
December 22, 2016: Neurobiology of Aging
https://www.readbyqxmd.com/read/28079593/improving-the-clinic-laboratory-interface-in-the-context-of-hiv-diagnosis-treatment-and-monitoring
#15
Timothy Johan Tucker, Peter Tsakani Manyike
PURPOSE OF REVIEW: Laboratory support is central to clinical medicine. The present review focuses on the health systems strengthening needs of the clinic-laboratory-interface (CLI) in developing countries within the context of HIV diagnosis, treatment, and monitoring. RECENT FINDINGS: Although significant improvements have been made in reducing error rates in the analytical phase of pathology services within laboratories, there remain substantial deficits in both the preanalytic and postanalytic phases of the entire value chain that require strengthening...
March 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28077275/investigations-of-blood-ammonia-analysis-test-matrices-storage-and-stability
#16
Brittany N Goldstein, Jordan Wesler, Amy S Nowacki, Edmunds Reineks, Marvin R Natowicz
An assessment of blood ammonia concentration is common medical practice in the evaluation of an individual with an unexplained mental status change or coma. The determination of a blood ammonia level is most commonly done using a glutamate dehydrogenase (GLDH)-based assay, although there are many potential sources of artifact and the literature is inconsistent regarding key preanalytic issues. Using a GLDH-based assay, we first investigated matrix effects using three anticoagulants: heparin, EDTA and oxalate...
January 7, 2017: Clinical Biochemistry
https://www.readbyqxmd.com/read/28074201/metabolic-stability-of-cells-for-extended-metabolomical-measurements-using-nmr-a-comparison-between-lysed-and-additionally-heat-inactivated-cells
#17
G Diserens, D Hertig, M Vermathen, B Legeza, C E Flück, J M Nuoffer, P Vermathen
NMR measurements for metabolic characterization of biological samples like cells, biopsies or plasma, may take several hours for advanced methods. Preanalytical issues, such as sample preparation and stability over the measurement time, may have a high impact on metabolite content, and potentially lead to misinterpretation. The aim of this study was therefore to investigate by (1)H HR-MAS NMR the impact of different cell handling preparation protocols on the stability of the cell metabolite content over the measurement time...
January 11, 2017: Analyst
https://www.readbyqxmd.com/read/28072712/seniorlab-a-prospective-observational-study-investigating-laboratory-parameters-and-their-reference-intervals-in-the-elderly
#18
Martin Risch, Urs Nydegger, Lorenz Risch
BACKGROUND: In clinical practice, laboratory results are often important for making diagnostic, therapeutic, and prognostic decisions. Interpreting individual results relies on accurate reference intervals and decision limits. Despite the considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are rarely available. The SENIORLAB study set out to determine reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28069401/analytes-related-to-erythrocyte-metabolism-are-reliable-biomarkers-for-preanalytical-error-due-to-delayed-plasma-processing-in-metabolomics-studies
#19
Mahim Jain, Adam D Kennedy, Sarah H Elsea, Marcus J Miller
BACKGROUND: Delaying plasma separation after phlebotomy (processing delay) can cause perturbations of numerous small molecule analytes. This poses a major challenge to the clinical application of metabolomics analyses. In this study, we further define the analyte changes that occur during processing delays and generate a model for the post hoc detection of this preanalytical error. METHODS: Using an untargeted metabolomics platform we analyzed EDTA-preserved plasma specimens harvested after processing delays lasting from minutes to days...
March 2017: Clinica Chimica Acta; International Journal of Clinical Chemistry
https://www.readbyqxmd.com/read/28062617/growth-differentiation-factor-15-as-a-biomarker-in-cardiovascular-disease
#20
REVIEW
Kai C Wollert, Tibor Kempf, Lars Wallentin
BACKGROUND: Growth differentiation factor 15 (GDF-15) is expressed and secreted in response to inflammation, oxidative stress, hypoxia, telomere erosion, and oncogene activation. Cardiovascular (CV) disease is a major driver of GDF-15 production. GDF-15 has favorable preanalytic characteristics and can be measured in serum and plasma by immunoassay. CONTENT: In community-dwelling individuals higher concentrations of GDF-15 are associated with increased risks of developing CV disease, chronic kidney disease, and cancer, independent of traditional CV risk factors, renal function, and other biomarkers (C-reactive protein, B-type natriuretic peptide, cardiac troponin)...
January 2017: Clinical Chemistry
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