Laboratorio Analisi Chimico Cliniche

Sotto il Monte Giovanni XXIII, Italy

Laboratorio Analisi Chimico Cliniche

Sotto il Monte Giovanni XXIII, Italy
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Amboni P.A.,Laboratorio Analisi Chimico Cliniche | Uberti L.,Sistemi Informativi
Rivista Italiana della Medicina di Laboratorio | Year: 2017

Background: Preanalytical phase still has some critical aspects hard to solve. One of these is the management of the information about the blood sample collection, the patient preparation and all the other information of all laboratory tests. All this information is usually collected inside a catalog and delivered to all wards on paper or on files of different formats. In this way the update, release and search of the information are difficult. Methods: To overcome these problems we developed a web software that can be updated and be read in real-time within any common internet browser. Results: The software is released under “GNU Lesser General Public License” (LGPL) licence so everybody can utilize and modify it freely. Conclusions: The acceptance of the software in the clinical wards was good, and we saw a consistent increase of its use over time. © 2017, Società Italiana di Patologia Clinica e Medicina di Laboratorio.


Antico A.,Laboratorio Analisi Chimico Cliniche | Tampoia M.,Laboratorio Of Patologia Clinica | Villalta D.,Allergologia e Immunologia Clinica | Tonutti E.,Allergologia e Immunopatologia | And 2 more authors.
Clinical and Developmental Immunology | Year: 2012

Aim. To assess the predictive value for chronic autoimmune gastritis (AIG) of the combined assay of anti-parietal-cell antibodies (PCA), anti-intrinsic-factor antibodies (IFA), anti-Helicobacter pylori (Hp) antibodies, and measurement of blood gastrin. Methods. We studied 181 consecutive patients with anemia, due to iron deficiency resistant to oral replacement therapy or to vitamin B12 deficiency. Results. 83 patients (45.8%) tested positive for PCA and underwent gastroscopy with multiple gastric biopsies. On the basis of the histological diagnosis, PCA-positive patients were divided into 4 groups: (1) 30 patients with chronic atrophic gastritis; they had high concentrations of PCA and gastrin and no detectable IFA; (2) 14 subjects with metaplastic gastric atrophy; they had high PCA, IFA, and gastrin; (3) 18 patients with nonspecific lymphocytic inflammation with increased PCA, normal gastrin levels, and absence of IFA; (4) 21 patients with multifocal atrophic gastritis with "borderline" PCA, normal gastrin, absence of IFA and presence of anti-Hp in 100% of the cases. Conclusions. The assay of four serological markers proved particularly effective in the diagnostic classification of gastritis and highly correlated with the histological profile. As such, this laboratory diagnostic profile may be considered an authentic "serological biopsy." © 2012 Antonio Antico et al.


Tampoia M.,Laboratorio Patologia Clinica i | Zucano A.,Laboratorio Patologia Clinica i | Villalta D.,Allergologia e Immunologia Clinica | Antico A.,Laboratorio Analisi Chimico Cliniche | Bizzaro N.,Laboratorio Patologia Clinica
Dermatology | Year: 2012

Background: Autoimmune blistering skin diseases are a heterogeneous group of diseases characterized by autoantibodies against structural components of the skin. In pemphigus vulgaris (PV) autoantibodies react mainly with desmoglein 3 (Dsg3) alone and/or in combination with desmoglein 1 (Dsg1). In bullous pemphigoid (BP) autoantibodies target two hemidesmosomal proteins, BP180 and BP230. Objective: To evaluate the diagnostic accuracy of a new indirect immunofluorescence (IIF) multiplex biochip method for the detection of anti-skin specific autoantibodies. Methods: Sera from 36 patients with PV and from 40 patients with BP were collected. The control group included 54 patients with other skin diseases and 40 healthy subjects. The detection of circulating autoantibodies to Dsg1, Dsg3, BP230 and BP180 was performed with a new IIF multiplex biochip method and with two currently commercially available ELISA methods. Results: The multiplex IIF method showed a high diagnostic sensitivity (100%) for PV on cells transfected with Dsg3. In patients with BP, the positivity to the BP180 antigen was higher (90%) than that on monkey esophagus (50%) and on cells transfected with BP230 (40%). A good rate of agreement was observed among methods (IIF vs. ELISA) and among ELISA systems. Conclusions: The new multiplex biochip IIF method has a high diagnostic accuracy for the diagnosis of PV and BP, comparable to ELISA methods, and is able to screen autoimmune bullous diseases. Copyright © 2012 S. Karger AG, Basel.


Ceriotti F.,Servizio Of Medicina Of Laboratorio | Brugnoni D.,Laboratorio Analisi Chimico Cliniche | Mattioli S.,Presidio
Clinical Chemistry and Laboratory Medicine | Year: 2015

Background: Internal quality control (IQC) is an everyday practice described in several documents. Its planning requires the definition of quality goals and a documentation system able to provide alarms as soon as the goals are not reached. We propose the use of the uncertainty approach to develop an effective alarm system. Methods: The use of the uncertainty information to verify the conformity to specifications is described. A top-down approach to the definition of the uncertainty of the method is described. Once the uncertainty is calculated, the complete measurement result (result±expanded uncertainty) is compared with the maximum permissible error (quality goal). An alternative and more immediate presentation is obtained defining an "acceptance zone" derived from the maximum permissible error reduced on either sides by expanded uncertainty. This approach is applied to two analytes: glucose and creatinine. Results: The relationship between quality goal and expanded uncertainty defines the width of the acceptance zone; if uncertainty is equal or larger than the quality goal, the goal is not attainable. Conclusions: The proposed approach uses an information, expanded uncertainty, that each laboratory seeking ISO 15189 accreditation should already have. The data presentation is immediate and easy to interpret allowing a direct comparison between the performance of the method and the quality goals. © 2015 by De Gruyter.


Lippi G.,Unita Operativa Diagnostica Ematochimica | Avanzini P.,Unita Operativa Diagnostica Ematochimica | Campioli D.,Laboratorio Analisi Chimico Cliniche | Da Rin G.,Struttura Complessa Medicina Of Laboratorio | And 4 more authors.
Clinical Biochemistry | Year: 2013

Objectives: Despite manufacturers' claim that systematical assessment of serum indices does not impact on testing efficiency, there is widespread perception that this practice may increase the turnaround time (TAT). A multicenter investigation was planned to verify TAT and performance of serum indices on five different clinical chemistry analyzers. Design and methods: Twenty study samples prepared from pooled sera of outpatients, emergency department, intensive care unit and dialyzed patients were divided in aliquots and shipped to 5 different laboratories. According to local instrumentation (Beckman Coulter AU5800, Roche Cobas 6000, Siemens Dimension Vista 1500, Abbott Architect c 16000 and Ortho Vitros 5.1/FS) and reagents, 13 clinical chemistry parameters were assayed on all study samples, with or without contextual assessment of serum indices. Results: The TAT with assessment of serum indices modestly or even negligibly increased, and varied from 0.2 to +. 5.0% (i.e., from 3 to +. 85. s). When using the lowest thresholds for sample acceptability, the agreement of hemolysis index (HI) among different instruments was comprised between 0.62 and 1.00 (all p. <. 0.01), but was higher than 0.80 in only 4/10 cases. The agreement of icteric and lipaemic indices could not be estimated due to the low number of samples exceeding acceptability criteria. Conclusions: The results of this study confirm that systematical measurement of serum indices does not impair instrument efficiency. The comparison of HI also suggests that major harmonization may be advisable for this measure among different manufacturers and instrumentations. © 2013 The Canadian Society of Clinical Chemists.


Braga F.,University of Milan | Braga F.,Laboratorio Analisi Chimico Cliniche | Dolci A.,Laboratorio Analisi Chimico Cliniche | Mosca A.,University of Milan | And 2 more authors.
Clinica Chimica Acta | Year: 2010

Background: The measurement of glycated hemoglobin (HbA1c) has a pivotal role in monitoring glycemic state in diabetic patients. Furthermore, the American Diabetes Association has recently recommended the use of HbA1c for diabetes diagnosis, but a clear definition of the clinically allowable measurement error is still lacking. Information on biological variability of the analyte can be used to achieve this goal. Methods: We systematically reviewed the published studies on the biological variation of HbA1c to check consistency of available data in order to accurately define analytical goals. Results: The nine recruited studies were limited by choice of analytic methodology, population selection, protocol application and statistical analyses. Conclusions: There is an urgent need to determine biological variability of HbA1c using a specific and traceable assay, appropriate protocol and appropriate statistical evaluation of data. © 2010 Elsevier B.V.


Infusino I.,Laboratorio Analisi Chimico Cliniche | Infusino I.,University of Milan | Dolci A.,Laboratorio Analisi Chimico Cliniche | Panteghini M.,Laboratorio Analisi Chimico Cliniche | Panteghini M.,University of Milan
Biochimica Clinica | Year: 2013

Measurements of serum immunoglobulin κ and λ free light chains (FLC) and FLC ratio calculation are recommended for the evaluation of plasma cell disorders. In this study we evaluated the performance of SPAPLUS analyzer using FreeliteTM reagents (both from The Binding Site) for FLC determination. Particularly, we compared the system performance with allowable goals for bias, imprecision and total error derived from biological variation of FLC. We evaluated the SPAPLUS FLC using data collected during a 10-month period of routine use, employing three different reagent lots. The two-level (N and H) SPAPLUS control material was used for bias estimate by comparing the obtained long-term experimental means (n=54, both levels) to the corresponding manufacturer's assigned values. The protocol for CV evaluation employed the liquid-frozen Bio-Rad Liquichek unassayed chemistry control, measured in each performed run (n=48). Inaccuracy was checked by results from five UK-NEQAS exercises [system-specific (SPAPLUS) consensus value as reference]. Average cumulative bias was -1.5% (control N) and -1.4% (control H) for κ FLC, and +6.6% (N) and +6.3% (H) for λ FLC, respectively. Overall CV at physiological concentrations resulted in 10.6% for κ FLC, 8.0% for λ FLC and 9.9% for FLC ratio. On EQAS evaluation, all λ FLC, four κ FLC and three FLC ratio results were within the minimum allowable total error. Considering our previous experience with other analytical systems, the SPAPLUS solution undoubtedly represents a significant step forward. However, a further improvement in measurement imprecision is probably needed to fulfill the stringent analytical goals derived from FLC biological variation.


Dolci A.,Laboratorio Analisi Chimico Cliniche | Vernocchi A.,Centro Of Medicina Of Laboratorio E Anatomia Patologica Multilab
Biochimica Clinica | Year: 2012

Serum protein electrophoresis (SPE) is a screening test widely used in clinical practice to identify patients with monoclonal gammopathies. SPE, performed on agarose gel (AGE) or by capillary zone electrophoresis (CZE), is the only technique able to recognize a monoclonal immunoglobulin. To detect monoclonal components (MC), SPE must be visually inspected. The two available techniques show similar sensitivity for MC detection (CZE 95%, AGE 91%), with a higher specificity for AGE (99% vs. 78% for CZE). Any MC detected must be reported, because also small B-cell clones could be dangerous. Once detected, MCs need to be quantitatively measured directly on the SPE pattern by setting the limits of the corresponding peak. A concentration-related bias in MC quantitation between AGE and CZE exists. Immunotyping is the further mandatory test for confirmation and characterization of MC by either immunofixation (IFE) or immunosubtraction (ISE). In general, IFE is more sensitive than ISE, but high resolution (HRIFE) must be warranted. However, ~25% of IFE carried out on commercially available kits are difficult to interpret and thus not reportable. For identification of amyloidogenic light chain MC, sensitivity of the manual HR-IFE is 95% vs. 80% of conventional semiautomated assays. The recently introduced quantitative serum assay for immunoglobulin free light chains (FLC) is an accurate index of clonality, particularly for FLC myeloma and AL amyloidosis. To reach the highest sensitivity in MC detection a comprehensive screening panel including SPE, HR-IFE and FLC determination is recommended.


Ferraro S.,Laboratorio Analisi Chimico Cliniche | Mozzi R.,Laboratorio Analisi Chimico Cliniche | Panteghini M.,Laboratorio Analisi Chimico Cliniche
Clinical Chemistry and Laboratory Medicine | Year: 2014

In our hospital, we are currently working to manage the appropriateness of vitamin B12 (B12) testing. Unfortunately, the classic evidence-based approach is unhelpful in this process and meta-analyzing data on the accuracy of this marker for cobalamin deficiency detection is misleading due to the lack of reference diagnostic methods. The approach currently proposed by the Health Technology Assessment (HTA) enables us to tackle the issue of B12 requests as a "healthcare" problem by considering the position of stakeholders involved in ordering, performing, interpreting the test, and receiving its results. Clinical expectations, methodological issues, and ethical aspects concerning the performance of the test can aid us in providing more guidance on the use of this marker. By building such structured information, hemodialysis patients and pregnant women have emerged as those groups preferentially requiring B12 testing, as it may potentially improve the clinical outcome. To avoid misinterpretation of B12 results more care should be taken in considering its biochemical and biological features, as well as the analytical issues. Spurious values obtained by current automated immunoassays may reflect suboptimal pre-analytical steps as well as known interfering conditions. Furthermore, the harmonization of results by available methods is still a farreaching goal and the approach to interpret an individual's results should be improved. Tracing a roadmap for B12 testing by exploiting the HTA model to balance the stakeholders' claims and maximizing the patient's outcome may help to manage the marker demand.


Perobelli S.,Cystic Fibrosis Center | Nicolis E.,Laboratorio Analisi Chimico Cliniche | Assael B.M.,Cystic Fibrosis Center | Cipolli M.,Cystic Fibrosis Center
American Journal of Medical Genetics, Part A | Year: 2012

To assess psychosocial functioning and quality of life in a representative group of adult and young patients with Shwachman-Diamond syndrome (SDS), all patients 3 years old and over included in the Italian SDS Registry were investigated using an ad-hoc questionnaire for information about demography, education, socialization, rehabilitation therapy, and standardized questionnaires [SF-36, Child Behavior Check-List (CBCL)] for quality of life and behavior. Results were compared with those of a Cystic Fibrosis (CF) patient group, matched for age and sex. Eighty-one percent of patients answered. All but one adult patient lived with their parents, 24% had independent income, and 57% had a driver's license. Different levels (from mild to severe) of cognitive impairment were reported by 76% of the adults and by 65% of the young patients. These data are significantly lower than those of the CF group. Both groups present low scores in the emotional and mental health evaluations at SF-36, but SDS patients reported significantly more limitations in physical functioning (PF) and more body pain (BP) experiences. As reported by parents at CBCL, young SDS patients show more "social problems" (in the clinical area 31% SDS vs. 6% CF), "attention deficits disorder" (29% SDS vs. 0%CF), and "somatic complaints" (24% SDS vs. 12% CF). Psychosocial functioning is impaired in the majority of SDS patients, significantly more than in patients affected by CF. © 2012 Wiley Periodicals, Inc.

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