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Pesaro, Italy

Vieira K.F.,University of Sao Paulo | Vieira K.F.,Setor Of Imunoquimica Do Laboratorio Clinico | Shitara E.S.,University of Campinas | Shitara E.S.,Laboratorio Clinico | And 2 more authors.
Jornal Brasileiro de Patologia e Medicina Laboratorial | Year: 2011

The use of quality indicators has been appreciated in laboratory management so as to optimize quality and error quantification in several laboratory processes. Furthermore, it assists in the implementation of preventive and corrective measures and it shows their corresponding efficiency. The objective of the present study is to discuss the evolution of quality, mainly in the laboratory area, focusing on the importance of quality indicators in laboratory management. Some pre-analytical, analytical and post-analytical laboratory indicators are also presented and discussed in this work. Finally, we highlight the Brazilian initiative in the Laboratory Indicator Program developed by the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML) in partnership with Control-Lab and the Model of Quality Indicator project, which has been developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

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.

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: http://www.sagepub.co.uk/ journalsPermissions.nav.

Vasikaran S.,PathWest Laboratory Medicine | Vasikaran S.,University of Western Australia | Eastell R.,Center for Biomedical Research | Bruyere O.,University of Liege | 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.

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.

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