Patologia Clinica

San Giorgio di Pesaro, Italy

Patologia Clinica

San Giorgio di Pesaro, Italy

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Villalta D.,Allergologia e Immunologia Clinica | Tampoia M.,Patologia Clinica | Alpini C.,Laboratrio di Chimica Clinica | Brusca I.,Laboratorio Analisi | And 2 more authors.
Clinica Chimica Acta | Year: 2010

Background: Anti-fibrillarin (AFA), anti-RNA polymerase (anti-RNAP), and anti-PM-Scl autoantibodies are useful markers for the diagnosis of systemic sclerosis (SSc) in patients who are anti-centromere- (ACA) or anti-topoisomerase I (anti-topo I)-negative, but, until recently, the only specific method for their identification was the radio-immunoprecipitation assay.The aim of this study was to evaluate the clinical accuracy of the new enzyme-linked immunosorbent assays (ELISA) developed by Phadia for their detection. Methods: Sera of 50 ACA and anti-topo I-negative SSc patients, and, as control group, sera of 122 patients (42 with SSc, ACA or anti-topo I-positive, 40 with systemic lupus erythematosus and 40 with rheumatoid arthritis) were studied. Result: Using the cutoff proposed by the manufacturer (10. AU/mL), sensitivity and specificity were: for AFA, 22% and 92.6%; for anti-RNAP, 16% and 97.5%; and for anti-PM-Scl, 8% and 98.8%, respectively. Using a cutoff corresponding to 98.8% specificity for all three antibodies, sensitivity was 10%, 14% and 8%, respectively. The combined use of these three antibody assays enabled identification of 32% of ACA- and anti-topo I-negative SSc patients. Conclusions: These new ELISA methods for AFA, anti-RNAP III and anti-PM-Scl detection have good diagnostic specificity, and may help identify a subset of SSc patients ACA and anti-topo I-negative. © 2010 Elsevier B.V.

Vasikaran S.,Royal Perth Hospital | Vasikaran S.,University of Western Australia | Eastell R.,Northern General Hospital | Bruyere O.,University of Liège | And 10 more authors.
Osteoporosis International | Year: 2011

Summary: The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend that a marker of bone formation (serum procollagen type I N propeptide, s-PINP) and a marker of bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) are used as reference analytes for bone turnover markers in clinical studies. Introduction: Bone turnover markers (BTM) predict fracture risk, and treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. The aims of this report were to determine their clinical potential in the prediction of fracture risk and for monitoring the treatment of osteoporosis and to set an appropriate research agenda. Methods: Evidence from prospective studies was gathered through literature review of the PUBMED database between the years 2000 and 2010 and the systematic review of the Agency for Healthcare Research and Quality up to 2001. Results: High levels of BTMs may predict fracture risk independently from bone mineral density in postmenopausal women. They have been used for this purpose in clinical practice for many years, but there is still a need for stronger evidence on which to base practice. BTMs provide pharmacodynamic information on the response to osteoporosis treatment, and as a result, they are widely used for monitoring treatment in the individual. However, their clinical value for monitoring is limited by inadequate appreciation of the sources of variability, by limited data for comparison of treatments using the same BTM and by inadequate quality control. IOF/IFCC recommend one bone formation marker (s-PINP) and one bone resorption marker (s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to compare the performance of alternatives and to enlarge the international experience of the application of markers to clinical medicine. Conclusion: BTM hold promise in fracture risk prediction and for monitoring treatment. Uncertainties over their clinical use can be in part resolved by adopting international reference standards. © 2010 International Osteoporosis Foundation and National Osteoporosis Foundation.

Vasikaran S.,Royal Perth Hospital | Vasikaran S.,University of Western Australia | Cooper C.,University of Southampton | Cooper C.,University of Oxford | And 5 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2011

The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Bone Marker Standards (WG-BMS) has evaluated the clinical potential of bone turnover markers (BTMs) in the prediction of fracture risk and for monitoring treatment. Research evidence suggests that BTMs may provide information on fracture risk independently from BMD, so that fracture risk prediction might be enhanced by their inclusion in assessment algorithms. The potential use of BTMs to predict the response to treatments for osteoporosis in the individual patient is also of great interest. Treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. However, there is still a need for stronger evidence on which to base practice in both situations. IOF/IFCC recommends one bone formation marker (serum procollagen type I N propeptide, s-PINP) and one bone resorption marker (serum C-terminal cross-linking telopeptide of type I collagen, s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to enlarge the international experience of the application of markers to clinical medicine and to help resolve uncertainties over their clinical use. © 2011 by Walter de Gruyter Berlin Boston.

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.

PubMed | Laboratorio Of Patologia Clinica, Laboratorio Analisi Chimico Cliniche, Patologia Clinica, Laboratorio Analisi Chimico Cliniche e Microbiologiche and 3 more.
Type: Journal Article | Journal: Journal of clinical laboratory analysis | Year: 2016

Autoimmune hepatitis (AIH) is a rare condition characterized by the presence of autoantibodies distinctive of type 1 AIH (AIH-1) and type 2 AIH (AIH-2). The aim of this study was to evaluate the autoantibody profile in a cohort of pediatric and adult AIH patients, using both indirect immunofluorescence (IIF) and a new multiplexed line-blot assay.Sera from 63 pediatric and 53 adult AIH patients were tested for antinuclear (ANA), antismooth muscle (SMA), anti-liver kidney microsome 1 (anti-LKM1), anti-liver cytosol 1 (anti-LC1) autoantibodies using IIF methods; for anti-LKM1, anti-LC1, and soluble liver antigen/liver-pancreas (anti-SLA/LP) autoantibodies using the line-blot; for anti-F-actin autoantibodies using IIF both on VSM47 cell-line and on rat intestinal epithelial cells.AIH-1 was the most common type of AIH in the adult cohort (73.6%), while AIH-2 was the most common AIH in the pediatric cohort (61.9%). Both in adult and pediatric AIH-2 anti-LKM1 were the prevalent autoantibodies. In pediatric AIH-2 anti-LC1 autoantibodies were more frequent than in adult AIH-2 (59 vs. 28.6%), and in 35.9% of cases they were present alone. In 17 patients anti-LC1 autoantibodies were detected only with the line-blot assay. The levels of anti-LKM1 and of anti-LC1 were not different between adult and pediatric AIH, and the overall agreement between the results obtained with the two IIF methods for F-actin detection was 98.8% (CI 95%: 94.4-99.7%).The line-blot assay showed a higher sensitivity than IIF for anti-LC1 detection. Anti-LKM1 and anti-LC1 autoantibody levels are not different in adults and children. An almost perfect agreement between the two IIF methods for anti-F-actin detection has been observed.

Bertero M.T.,Immunologia Clinica | Bazzan M.,Ematologia e Malattie Trombotiche PO Turin Nord Emergenza S. Giovanni Bosco | Carignola R.,Day Hospital Internistico Centralizzato | Montaruli B.,Patologia Clinica | And 5 more authors.
Lupus | Year: 2012

We report the experience from the Antiphospholipid Antibodies (aPL) Regional Consortium in northwest Italy, meant to support clinical research and foster collaboration among health professionals regarding the diagnosis and management of antiphospholipid syndrome (APS) patients. This cohort-study (APS Piedmont Cohort) was designed to register the clinical characteristics at inception and associated immunological manifestations at diagnosis (if any) of patients who strictly fulfilled the current criteria for APS, all recruited at the Piedmont and Valle d'Aosta regions.Clinical and laboratory data from 217 APS patients (171 with vascular events, 33 with pregnancy morbidity and 13 with both), from 16 centres within the geographical area were collected. Venous thrombosis was recorded in 45.6% of patients, arterial thrombosis in 35%, small-vessel thrombosis in 1.12% and mixed arterial and venous thrombosis in the remaining 19.4% of the cases. Pregnancy morbidity included 19 patients with unexplained fetal death beyond the 10th week of pregnancy, 17 with premature birth before the 34th week and 10 with three or more unexplained spontaneous abortions before the 10th week of gestation. This consortium represents an instrument by which to audit clinical practice, to provide counselling to local centres and to sustain future basic and clinical APS research. © The Author(s), 2012. Reprints and permissions: journalsPermissions.nav.

Campana G.A.,Patologia Clinica | Oplustil C.P.,Microbiologia | De Faro L.B.,Medica Patologista Clinica
Jornal Brasileiro de Patologia e Medicina Laboratorial | Year: 2011

Clinical pathology/laboratory medicine, a specialty focused on performing complementary tests to aid diagnosis, has impact upon several stages of health care: prevention, diagnosis, prognosis, and therapeutic management. There are several factors that will foster the use of laboratory medicine in the future. In order to discuss the main trends in laboratory medicine, this article describes the major factors that have promoted growth in this market, which herein are referred to as growth drivers. The major trends that will cause substantial impact on laboratory medicine are: management tools, inclusion of new tests and procedures, service quality, operational models, automation, consolidation and integration, information technology, personalized and genetic medicine. Laboratory medicine occupies a pivotal role in 70% of all clinical decisions with minimal healthcare costs of approximately 10%. All trends discussed herein sustain an increase in the use of laboratory tests as well as its importance in health care. Both this new model and the expectation of optimal solutions have led the market to search for changes and new management strategies.

Background.: Urine sediment analysis remains essential for diagnosis, prognosis, and follow-up of patients with renal and urinary tract diseases. Given the large volume of requests in daily routine of most laboratories, automated systems for sediment analysis were designed and commercialized. The systems currently available are based on two different technologies: urinary flow cytometry (UFC) and automated intelligent microscopy (AIM). We evaluated Iris iQ200 (AIM) before (basic evaluation) and after (routine evaluation) its introduction in the laboratory. The aim was to show the analytical performances and the diagnostic accuracy of Iris iQ200 and its role for optimizing diagnostic strategy in urinary sediment analysis. Methods.: The basic evaluation measured between- and within-run imprecision, linearity, carryover, and accuracy as comparison versus reference methods (ISLH and microbiologic culture) in 153 selected samples. The routine evaluation determined clinical sensitivity for renal diseases and urinary infections (UTIs) as number of pathological results, number of RBCs, number of casts before and after introduction of iQ200 and as NPV (negative predictive value) of some formulas ("bacteria + all small particles [ASP]≥12,000 μL" on 253 samples; "ASP AND/OR WBC" and "bacteria after human validation" on 7615 samples) versus microbiologic culture. In both evaluations, we analyzed workflow and TATs. Results.: In basic evaluation, iQ200 showed precision less good than UFC but much better than microscopy (<15% at diagnostic limits), linearity up to 2000 particles/μL, negligible carryover, and good comparison for RBCs (r 0.9335), WBC (r 0.9987), squamous epithelial cells (0.9544), less good for non squamous epithelial cells (r 0.7642) and hyaline casts (0.7210) and for non hyaline casts (0.3365). NPV for formula "bacteria + ASP ≥ 12,000/μL" versus culture (CFU ≥ 100,000/mL) was 96.4%. In routine evaluation, we noted an increase of pathological results (+18%) after introduction of iQ200, mainly for RBCs (half over the diagnostic limit) and hyaline casts (from 1.5% to 4.5%). The pathologic casts showed an increase of 7%. Versus microbiologic culture (CFU ≥ 100,000/mL), "ASP AND/OR WBC" showed NPV 98.5%, and "bacteria after human validation" NPV 99.7%. The analysis of workflow demonstrated less than 2% of dilutions and less than 1% of microscopic controls. 33% (27% after optimization) of samples needed verification, by revision criteria "pathologic and anomalous results". In a routine of 350 samples per day, the saved time was 60 min and 160 min with 1 or 2 iQ200, respectively. Conclusions.: iQ200 can used in combined or selective diagnostic strategy for urinary sediment with improvements in diagnostic efficacy (more pathologic results; precise and accurate follow-up; good UTIs screening) and in efficiency (reduced workload and TATs). Moreover, iQ200 allows studying, teaching, and inter-observers consultation about urinary morphology. © 2013 Springer-Verlag Italia.

Brunetti M.,Patologia Clinica | Pregno S.,Public Health Physicians Modena | Schunemann H.,McMaster University | Plebani M.,University of Padua | Trenti T.,Patologia Clinica
Clinical Chemistry and Laboratory Medicine | Year: 2011

Laboratory data play a pivotal role in the clinical decision-making process. Major transformations have occurred in laboratory medicine in recent decades. To face the economic pressures, hospital laboratories are forced to enhance efficiency. Decisions on policy and practice take place at many levels. However, decision-making often does not follow Evidence Based Laboratory Medicine principles. Also, the literature shows limited influence of economic evaluations on health care decisions and diagnostic processes. Several barriers to the use of economic evaluation in decision-making process have been identified, and guidelines tend to focus on issues of effectiveness and have not explicitly considered broader issues, particularly cost. As an example, we analyzed recommendations on the use of brain natriuretic peptide (BNP) or N-terminal fragment of the prohormone BNP (NT-proBNP) in patients with chronic heart failure. All guidelines recommend the use of BNP if available. Nevertheless, none included economic data explicitly, even if economic information exists in the literature. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group, propose using a balance sheet approach, one way of helping decision makers to explicitly consider resource use along with other outcomes when making recommendations. Key aspects of GRADE, such as the explicit presentation of information and the quality evaluation of the economic data can help overcome barriers in the use of economic evaluations in the decision-making in process. This approach can help to give health decision makers, clinical guideline panels and patients, a better appreciation of the overall health benefits, harms and costs of laboratory tests. © 2011 by Walter de Gruyter Berlin New York.

PubMed | Allergologia e Immunologia Clinica, University of Siena, Patologia Clinica and University of Bari
Type: Journal Article | Journal: Clinical and experimental rheumatology | Year: 2016

Anti-cyclic citrullinated peptide antibodies (anti-CCP) are a serological marker of rheumatoid arthritis (RA), and also have a prognostic value for more aggressive disease. Whether anti-CCP levels may change during treatment according to clinical response is matter of debate. Likewise, it is unknown whether different biological drugs have peculiar effects on anti-CCP levels. This study aimed to investigate changes in anti-CCP serum levels in RA patients on biological drugs with different mechanism of action.We studied 71 patients with active RA tested positive for anti-CCP who started a first biological drug (54 anti-TNF- drug, 9 rituximab, 8 tocilizumab). In 14 patients stopping anti-TNF- treatment for ineffectiveness, rituximab was started. Anti-CCP and rheumatoid factor (RF) isotypes (IgM, IgA, IgG) levels were measured at entry, 12 months and again at 12 months after swapping to rituximab.After 1 year of therapy of the first biological drug, patients taking anti-TNF- drugs showed a significant reduction of the anti-CCP levels (p=0.002), and all RF isotypes (p=0.003). Also patients treated with rituximab or tolicizumab had a significant decrease in anti-CCP (p=0.01) and RF isotype levels (p=0.01). Anti-CCP levels did not correlated with DAS28 over time. In patients switching to rituximab after failure of TNF- blockers, anti-CCP levels did not change at 12 months (p=0.06), despite of the reduction of DAS28 (p=0.02) and RFs levels (p=0.02).Our study showed that anti-CCP levels may change during RA course, regardless of the biological drug used and the clinical response.

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