Maria Stella Graziani

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BC: Articoli scritti da T. Trenti

Paziente pediatrico con oliguria e adenopatia cervicale: il ruolo degli analizzatori a cattura di immagine per l’esame standard delle urine
Urinalysis in a pediatric patient with oliguria and cervical lymphadenopathy: role of automated imageanalysis systems.
<p>Automated urinalysis instruments image-based for cell analysis can identify non-squamousepithelial cells (NSE). Among these elements, expert pathologists can distinguish the so called Decoy Cells (DC),Polyomavirus BK (BKV)-infected elements primarily seen in immunocompromised patients. Epstein-Barr virus (EBV)infection can induce a transient immunosuppression in immunocompetent patients, and this could lead to areactivation of a latent BKV infection in urothelial cells: this is a rare event in pediatric patients. This study reports thecase of a 4 year-old child with lateral lymphadenopathy, fever and oliguria. Automated urinary sediment analysisevidenced the presence of many NSEs identifed as DC, generating a subsequent virological investigation with a finaldiagnosis of concomitant BKV and EBV infection. The combination of an automated technology, an efficientmiddleware and the expertise of the laboratory professionals , allowed the proper identification of these peculiarreactive elements, which could easily be mistaken for malignant atypical cells.</p>
Biochimica Clinica ; 43(2) e20-e23
Casi Clinici - Case Report
Siero o plasma? Un quesito non nuovo che attende risposte nuove
Serum or plasma? An old question awaiting for new answers.
<p>There is a continual debate on what type of sample a clinical laboratory should use. While serum is still considered the gold standard and remains the required sample matrix for some assays, laboratories must consider turn-around time, which is an important metric for laboratory performance and, more importantly, plays a critical role in patient care. In addition, a body of evidence emphasize the choice of plasma samples in order to prevent modifications of some measurands due to the coagulation process and related interferences. Advantages and disadvantages of serum and plasma are discussed on the basis of current literature and evidence. In addition, data are provided on the current utilization of the matrix (serum or plasma) in Italy and in other Countries. Finally, a rational for a possible shift from serum to plasma is provided.</p>
Biochimica Clinica ; 43(2) 178-186
Documenti - Documents
Disegno e sviluppo di una applicazione per dispositivi mobili per migliorare l’appropriatezza prescrittiva degli esami di laboratorio del medico di medicina generale: focus sull’ipertensione arteriosa
An application for mobile devices to improve the appropriateness of laboratory test request by general practitioners: focus on blood hypertension
<p>The prevalence of consultations of general practitioners (GPs) is huge, and for an unknown number of patients a consistent amount of diagnostic laboratory tests is requested. One of the tasks of GPs is to identify patients in need of specific laboratory tests, to improve the patient outcomes taking at the same time into consideration the risk of over-diagnosis and treatment and the available resources as well. To support GPs in their decisional process, we developed a dedicated software application (APP) for mobile devices; the APP contents were developed in collaboration with GPs, with students of a GP training course and with laboratory medicine specialists. We identified the laboratory tests useful for the management of the most frequent diseases observed in GPs&#39; offices,&nbsp; that are supported by the best available evidence. The first attempt was made considering blood hypertension. Aim of the paper is the description of the process of the APP development,&nbsp; that&nbsp; includes data available from national and international guidelines. This promising tool could help GPs to prescribe suitable laboratory tests in different clinical scenario (diagnosis, evaluation of therapy, monitoring) and to promote the implementation of the evidence-based practice of laboratory medicine, reducing the requests of inappropriate tests and accurately identifying patients who need a second level referral (nephrologist, endocrinologist).</p>
Biochimica Clinica ; 43(1) 052-058
Contributi Scientifici - Scientific Paper
Il Grading of Recommendations Assessment Development and Evaluation(GRADE) quale metodologia sistematica e trasparente per valutare l’esame di laboratorio nella formulazione di raccomandazioni e linee guida
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology assystematic and transparent framework to evaluate diagnostic test value in supporting guide lines andrecommendations issuing.
<p>A multidimensional pathway based on GRADE Evidence to Decision (EtD) frameworkis presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and theconsequences of the decision. The framework includes three sections reflecting the main steps of GRADE EtD:formulating the relevant question, making an assessment of the evidence, and drawing conclusions. As a matter ofexample, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis inneonates including seven dimensions: (1) formulating the question; (2) assessment of diagnostic test accuracy; (3)certainty of the evidence; (4) effects of test on the main patient outcome; (5) balance between the desirable andundesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidatethe concepts and to show how reviewers may complete each dimension with the relevant information avaiable.Several factors could influence the final decisions: the relevance of the problem, the values of diagnostic accuracy,the effects of the test on main patient outcome; other issues may play a role. The framework consists of acomprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. Thisapproach could help health professionals to use the best available research evidence in a structured and transparentway to inform decisions in the context of laboratory medicine.</p>
Biochimica Clinica ; 43(1) 076-089
Documenti - Documents
La riorganizzazione del settore dedicato alla diagnostica proteica: un esempio virtuoso fondato su criteri di Evidence Based Laboratory Medicine e di sostenibilità economica
The organization of the protein unit: a beneficial example founded on evidence based laboratory medicine criteria and on the appropriate use of the available resources
P. Natali  |  T. Trenti  | 
<p>The sustainability of the National Health Service is a current subject of debate&nbsp; due to the pressure that the changes in our societies are having on health systems. Reviewing diagnostic processes is increasingly urgent to contain costs and to maintain the quality of the health services provided.The Evidence Based Laboratory Medicine (EBLM) approach allows to identify and eliminate obsolete methods, replacing them with more adequate ones. The EBLM approach can also provide higher diagnostic accuracy, a rationalisation of diagnostic pathways, a reduction of turnaround-time and a decrease of costs. To reach these objectives, a careful analysis of production processes and assessment of the costs are both necessary. The EBLM approach has been applied to the Protein Unit of Laboratory of Modena. The change in the workflow of the Bence Jones protein determination and the consolidation of the measurement of a number of serum proteins on clinical chemistry analysers allowed a better diagnostic accuracy coupled to important economical savings. The savings made it possible to extend the availability of the free light chains measurements (that before was restricted to patients admitted to the haematology department) to the out-patients of the Province of Modena. The EBLM approach is the most effective way to reach such objectives: really, providing better quality performance does not necessarily correspond to an increase of costs. In addition to developing an adequate level of scientific expertise, the laboratory professional must acquire managerial skills to introduce up-to-date diagnostic methods and to optimize the use of assigned resources, in all areas of laboratory medicine.</p><p>&nbsp;</p>
Biochimica Clinica ; 43(1) 044-051
Contributi Scientifici - Scientific Paper
Efficacia e utilità del monitoraggio terapeutico di autoanticorpi e farmaci inibitori del Tumor Necrosis Factor alpha in pazienti in trattamento per patologie autoimmuni
Therapeutic monitoring of autoantibodies Tumor Necrosis Factor α inhibitor drugs: efficacy and benefit for patients with autoimmune diseases
<p>Therapeutic monitoring of autoantibodies Tumor Necrosis Factor &alpha; inhibitor drugs: efficacy and benefit for patients with autoimmune diseases. Tumor necrosis factor alpha (TNF&alpha;) is a proinflammatory cytokine involved in the pathogenesis of chronic inflammatory disease, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Chron&rsquo;s disease and ulcerative colitis. TNF&alpha; inhibitors (anti-TNF&alpha;) are monoclonal antibodies drugs directed against TNF&alpha; (i.e. adalimumab, infliximab, etarnecept, golimumab and certolizumab). Their effect consists in reducing the inflammatory response of autoimmune diseases. Several randomized controlled trials and observational studies evaluated the therapeutic efficacy of these drugs and reported a clear benefit for patients affected by chronic inflammatory disease treated with anti-TNF&alpha;, but also a high risk of reactions and infections in the injection site. These drugs are immunogenic, and consequent anti-drug antibodies (ADA) formation may decrease the functional drug concentration resulting in a loss of response. Therefore, we evaluated the impact of ADA on therapeutic response through meta-analyses, showing that detectable ADA significantly reduced TNF&alpha; inhibitors response. ADA could interfere with drugs and compromise their effects, so the determination of serum ADA levels could improve the patient&rsquo;s management. Even if the decrease of therapeutic response, due to ADA production, is well documented, the clinical benefit of serum ADA determination remains unclear. At the moment, there are many indications about the use of immunogenicity test to guide the therapy, but more information should be acquired before implementing this test in clinical practice.</p>
Biochimica Clinica ; 42(3) 266-273
Documenti SIBioC - SIBioC Documents
Documento di consenso SIBioC-Medicina di Laboratorio e Academy of Emergency Medicine and Care (AcEMC) sull’utilizzo in Pronto Soccorso dei biomarcatori per la diagnosi di sepsi batterica
Biomarkers for diagnosing sepsis in the emergency department: a consensus document by SIBioCMedicina di Laboratorio and the Academy of Emergency Medicine and Care
<p>This article is drafted as a consensus document involving eight members of the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) and eight members of the Academy of Emergency Medicine and Care (AcEMC), to whom a questionnaire was submitted for obtaining opinions on some recommendations about the use of biomarkers for diagnosing sepsis and managing antibiotic therapy in the emergency department. These recommendations were drafted following the National Guidelines Program (PNLG). According to the cumulative consent, three &quot;A&quot; recommendations (strongly recommended indication) emerged, which include biomarker availability (always available on prescription), clinical use (always interpreted in according to clinical data) and timing of the request based on half-life of the analyte. Recommendations of type &quot;B&quot; (indications carefully considered) included a general agreement about the clinical usefulness of sepsis biomarkers, the combination of procalcitonin (PCT) and Creactive protein (CRP), the possibility to be free on prescription to the laboratory, the use of cut-offs favoring a high negative predictive value, the use of more analytically sensitive assays and the possibility of using PCT for monitoring antibiotic therapy, with timing of ordering defined according to the metabolism of the analyte. As regards the specific biomarkers, a similar &ldquo;B&rdquo; consensus has been reached for measuring both PCT and CRP, and for measuring lactic acid. The measurement of other biomarkers is discouraged except for presepsin, for which there is still substantial uncertainty in favor or against.</p>
Biochimica Clinica ; 42(1) 62-73
Documenti SIBioC - SIBioC Documents
Appropriatezza della richiesta di esami ed esiti clinici: il caso delle malattie renali, tiroidee e della celiachia
Appropriateness of test request and clinical outcome: the example of kidney, thyroid and coeliac disease
<p>This document analyzes the topic of appropriateness of test request. It is organized in 4 parts. The first deals with the theme of appropriateness, the consequences of insufficient or excessive test request and the need to balance guideline indications with the clinical need of a single patient. The other 3 parts present the cases of thyroid, chronic kidney and coeliac disease. With regard to the thyroid function, population screening, excluding neonates, is not recommended; on the contrary, it is highly recommended to evaluate the thyroid function in any individual with even only a minimal clinical suspect. The thyrotropin (TSH) is the test of choice with reflex free T4 and free T3, according to specific algorithms. The contemporaneous measurement of free FT3, free FT4 and TSH, except for specific cases, should be discouraged due to the high frequency of unjustified abnormal findings. Anti-thyroperoxidase antibodies are the test of choice for autoimmune thyroid diseases. In chronic kidney disease (CKD), the estimated glomerular filtration rate (eGFR) based on serum creatinine in most cases is the best indicator of renal function, provided that creatinine is measured with the accurate enzymatic method. In borderline situations, a confirmatory eGFR calculation based on cystatin C is recommended. Urinary albumin, expressed as albumin/creatinine ratio, is an essential complement for CKD staging. The diagnosis of coeliac disease requires integration between clinical, histological and serological data. The anti-transglutaminase IgA is the test of choice; only when an IgA deficit is present, the test to be used is IgG antigliadin deamidate peptides. The genetic HLA DQ2/DQ8 test is indicated for screening of subjects at risk: if negative, coeliac disease can be excluded.</p>
Biochimica Clinica ; 41(3) 266-285
Documenti - Documents
Il laboratorio clinico nelle indagini tossicologiche
The role of clinical laboratory in toxicological investigations
<p>Clinical toxicology laboratory activities are carried out both for clinical purposes, providing support to the diagnosis and treatment of intoxicated patients, and for medico-legal aspects, providing data with value of judicial proof. The new Italian law (no. 41, March 23, 2016) considers vehicular homicide and road traffic injuries criminal offences to be severely punished, especially if the driver is under the influence of alcohol or psychotropic substances. Since toxicology results have an impact on administrative and legal decisions, analytical reliability and traceability of data, including the implementation of a chain of custody of samples, are crucial. Forensic toxicological analyses use conventional matrices (blood and urine) and alternative matrices (hair, saliva, sweat). To assess the current use of illicit drugs, blood is the matrix of choice because substance concentrations correlate with subject&rsquo;s physical and mental status at the time of collection. On the other hand, urine testing is simple, rapid and non-invasive. A positive result indicates that the substance assumption was from several hours to a few days prior to sampling. The hair matrix is suitable to identify past use or abuse and segmental hair analysis allows the reconstruction of the history of abuse. Analytical methods for alcohol and drugs of abuse include qualitative screening tests and quantitative confirmatory tests. A negative result of the screening test does not require further investigation, while a positive result cannot assume forensic value without confirmatory analysis. The use of mass spectrometry in combination with chromatographic or electrophoretic separation techniques for confirmatory tests has found the consensus of the international scientific community.</p>
Biochimica Clinica ; 41(3) 216-227
Rassegne - Reviews
Accuratezza dell’immunonefelometria come metodo di screening per la determinazione della proteinuria di Bence Jones
Accuracy of immunonephelometry as a screening method for Bence Jones proteinuria
<p>The Bence Jones protein (BJP) is an important biomarker for the identification and management of patients with plasma cell dyscrasia. The recommended method for BJP detection is the immunofixation, which is a time consuming and expensive procedure. The aim of the study was to evaluate immunonephelometry (INA) as a screening method for the identification of urine samples negative for BJP and to compare it to a simplified immunofixation method (uIFE-3). First morning urine samples were collected from 1000 consecutive patients and analyzed by INA. Samples with free light chain concentrations &gt;10 mg/L and &gt;5 mg/L were considered positive. All samples were further analyzed by uIFE-3 using 3 antisera (anti-GAM, -&kappa; and -&lambda;). The INA results (at both cut-off levels) were compared with the uIFE-3, showing a poor accuracy due to the high number of false positives and false negatives. Consequently, INA resulted unable to accurately screen BJP.</p>
Biochimica Clinica ; 41(2) 148-153
Contributi scientifici - Scientific papers
Le revisioni della letteratura biomedica
The reviews of the biomedical literature
<p>The reviews of the biomedical literature aim to summarize and disseminate the knowledge about a specific topic intended as a disease treatment or a diagnostic biomarker. They include narrative and systematic reviews (SR). Narrative reviews simply describe the features about a specific topic. On the contrary, SR are performed to answer to a specific question by using a standardized methodology to obtain results that may be reproduced by other authors. SR may include studies of diagnostic or therapeutic efficacy and prognostic value according to the scope. SR of treatment efficacy are generally focused on the efficacy of a new treatment in comparison with the one considered as reference, commonly used in the clinical therapeutic protocols. SR focused on diagnostic test accuracy generally retrieve data on diagnostic sensitivity and specificity from original studies in order to estimate pooled likelihood ratios or predictive values. Finally, SR of prognostic studies explore the ability of a specific marker to predict the outcome of interest. A SR implies to plan a systematic literature search strategy by Medline and other biomedical databases, defining inclusion criteria for study selection. Statistical analyses allow to pool data in a meta-analysis to provide an estimates of the effect power. This paper summarize the main features of different type of SR to help readers in the comprension of a SR and meta-analysis. Their utility in clinical practice and biomedical research is also illustrated.</p>
Biochimica Clinica ; 41(2) 175-182
Documenti - Documents
Sensibilità al glutine: il test di attivazione dei basofili (BAT) può aiutare nella diagnosi differenziale?
Gluten hypersensitivity: basophil activation test (BAT) may help in the differential diagnosis
T. Scacchetti  |  D. Debbia  |  E. Boni  |  T. Trenti  | 
<p>Gluten hypersensitivity: basophil activation test (BAT) may help in the differential diagnosis? The main forms&nbsp;of gluten-related disorders are wheat allergy (WA), celiac disease (CD) and possibly immune-mediated disease&nbsp;(gluten sensitivity). S-IgE play an essential role in WA. For CD tests available are anti-tissue transglutaminase (tTG)&nbsp;IgA, anti-endomysium (EMA) and deamidated gliadin peptides (DGP) antibodies IgG particular. For other immunemediated&nbsp;diseases there is currently no test available. The usefulness of basophil activation test (BAT) in anaphylactic&nbsp;adverse reactions, late-onset allergy has been demonstrated. We report the case of a woman of 46 years old with&nbsp;disorders of wheat tied overt clinical signs, intestinal and extra-intestinal symptoms, whose tests above were all&nbsp;negative. Only the BAT showed a stimulation of basophils exposed (52.9%) to extract wheat. We diagnosed gluten&nbsp;sensitivity (GS) on the basis of an algorithm for the differential diagnosis of gluten-related disorders, including CD,&nbsp;GS and WA. We believe that the BAT confirms a hypersensitivity reaction to wheat not-IgE-mediated, not CD.</p>
Biochimica Clinica ; 40(4) e31-e34
Casi clinici - Case report
Raccomandazioni per l'implementazione e la gestione del "point-of-care testing" (POCT)
Recommendations for the implementation and management of the point-of-care testing (POCT)
Biochimica Clinica ; 35(3) 242
Medicina di Laboratorio e Medicina d’Urgenza: il connubio continua
Laboratory medicine and emergency medicine: a perpetual relationship.
<p>The essential goals that laboratorymedicine shall pursue to adequately fulfill clinical needs can be summarized in delivering high quality information,availability of clinically usable tests and turnaround time. The governance of urgent laboratory testing encompassesa harmonious integration of clinical needs and laboratory organization. Clinical laboratories shall hence be morefocused on the pre-preanalytical phase, be involved in proactive efforts for standardizing pre-analytical and analyticalprocedures, optimize the post-analytical and post-post-analytical phases, thus providing a complete information andallowing the achievement of favorable outcomes. Throughout this ample and multifaceted process, the strictcooperation between laboratory professionals and emergency physicians is pivotal. As rationale follow-up of thecollective article published concomitantly with the first joint Academy of Emergency Medicine and Care (AcEMC) -Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) meeting, this new collective paperaims to summarize the topics discussed during the second joint event &ldquo;Laboratory Medicine and EmergencyMedicine: a resumed link&rdquo;, specifically including the governance of urgent tests, acid-base disorders, venousthromboembolism, acute heart failure, trauma, acute intoxications, viral diseases and other emerging infections.</p>
Biochimica Clinica ; 17(1)
Documenti - DOCUMENTS