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Merano, Italy

The pressure for expenditure containment and the progressive reduction in available healthcare resources has led to abrupt cuts in hospital budgets, generating, in turn, downsized operations in the provision of medical services, including laboratory ones. These short term strategies are oriented by policy maker and health care manager purposes often neglecting appropriateness, effectiveness, quality improvement and, ultimately, impact on patient outcome. With the objective to reduce costs, diagnostic products are evaluated by the key criterion of 'cost-per-test', like buying household consumables, e.g. soaps, towels, etc. In this way, healthcare managers aim to downsize expenditures very quickly, with the assumption of no apparent negative impact on patient outcome. There is a need to introduce new rules, criteria and indicators to favor a quality-oriented selection. Industry competitors on the market should present not only a project specifically tailored to the laboratory organization, but also a well-structured strategic plan. This would facilitate laboratory professionals in evaluating the industry ability to share goals, responsibilities and management with a clinical laboratory organization, ensuring the best efficiency, effectiveness and cost savings. Of course, this should happen with a contemporaneous improvement in the expertise of clinical laboratory professionals.

Villalta D.,Allergologia e Immunologia Clinica | Sorrentino M.C.,Laboratorio Analisi Chimico Cliniche e Microbiologiche | Tampoia M.,Patologia Clinica | Alessio M.G.,Laboratorio Analisi Chimico Cliniche | And 5 more authors.
Clinica Chimica Acta | Year: 2015

Objective: To evaluate the autoantibody profile in patients with primary biliary cirrhosis (PBC) using a new multiplexed line-blot assay specifically designed for the diagnosis of autoimmune liver diseases. Methods: Sera of 58 consecutive PBC patients and 191 disease controls (144 with autoimmune liver diseases other than PBC, and 67 with non-autoimmune chronic liver diseases) were tested by both the multiplexed line-blot Autoimmune Liver Disease Profile 2 (ALD2) and by IIF on HEp-2 cells and on rat kidney/liver/stomach tissues. ALD2 contains the following PBC-associated antigens: AMA-M2, natively purified from bovine heart; M2-E3, a recombinant fusion protein including the E2 subunits of PDC, BCOADC and OGDC; sp100, PML and gp210 recombinant proteins. Results: With the ALD2 assay, a positive reaction to AMA-M2, M2-E3, sp100, PML and gp210 in PBC patients was observed in 77.6%, 84.5%, 34.5%, 15.1% and 18.9%, respectively, of the PBC sera. The overall sensitivity and specificity for PBC were 98.3% and 93.7%. Using IIF, positivity rates to AMA, and to antinuclear autoantibodies with membranous/rim-like and multiple nuclear dot patterns were 86.2%, 8.6% and 22.4%, respectively. The overall sensitivity and specificity for PBC of the IIF method were 86.2% and 97.9%, respectively. Conclusions: The ALD2 line-blot showed a good diagnostic accuracy for PBC and a higher sensitivity than the IIF method to detect sp100 and gp210 autoantibodies. © 2014 Elsevier B.V.

Mosca A.,University of Milan | Basilico N.,University of Milan | Grande R.,Laboratorio Centrale | Taramelli D.,University of Milan
Biochimica Clinica | Year: 2011

This overview covers several aspects of malaria, from basic information on the biology of the genus Plasmodium to the pathogenesis and diagnosis of the species infecting humans. Current treatment regimens and drug-resistance problems are also discussed. Particular attention is given to the various aspects of malaria epidemiology and to the cellular and immune mechanisms that may sustain the protection against malaria in subjects heterozygotes for various hemoglobin disorders. A short critical review of actual tools for the diagnosis and monitoring of malaria is also provided. Finally, a presentation of the Italian Malaria Network is outlined.

Porcelli B.,University of Siena | Alessio M.G.,Laboratorio Analisi Chimico Cliniche | Villalta D.,Allergologia e Immunologia Clinica | Bizzaro N.,Laboratorio Of Patologia Clinica | And 13 more authors.
Rivista Italiana della Medicina di Laboratorio | Year: 2015

In light of scientific evidence that has appeared over the last 10 years, the Study Group on Autoimmune Diseases of the Italian Society of Clinical Pathology and Laboratory Medicine has revised and updated the guidelines—first issued in 2005—on the correct and appropriate procedures for the diagnosis of celiac disease. The identification of non-celiac gluten sensitivity as a disease in itself also needed some clarification as to diagnosis and classification. The current version of the diagnostic guidelines takes the form of recommendations for proper use of available serological and genetic tests, and description of the different histological features, both to diagnose the disease and to define at risk subjects. Diagnostic and interpretative steps are formulated according to the purpose of the request (diagnosis, monitoring, screening) and the age of patients. The recommendations are the result of the latest available evidence in the literature, a consensus among the members of the study group and interdisciplinary work among clinical pathologists, immunologists and pathologists. They are designed to support the work of physicians in the everyday approach to the diagnosis of gluten-associated disorders. © 2015, Springer-Verlag Italia.

Caldini A.,Laboratorio Generale | Graziani M.S.,Azienda Ospedaliera Universitaria Integrata di Verona | Basile U.,Catholic University of the Sacred Heart | Cataldo I.,Laboratorio Of Patologia Clinica | And 6 more authors.
Biochimica Clinica | Year: 2014

This document examines laboratory tests to be used for the management of monoclonal gammopathies in different clinical scenarios, from screening to monitoring and assessment of the response to therapy. The content is based on international recommendations and guidelines currently available. It includes sections on the analytical aspects of different tests (serum protein electrophoresis, typing and quantification of monoclonal components, Bence Jones protein determination and free light chain measurement) and on their clinical significance as well. Different clinical settings are examined: screening, diagnosis, risk stratification, monitoring and response assessment. For each of those, laboratory tests to be used are indicated. Aim of the document is to help clinical laboratories avoiding unnecessary tests, ensuring in the meantime that all the investigations required for a optimal patient management are carried out.

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