Mauro Panteghini

Ospedale Luigi Sacco, Milano, Lombardy, Italy

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Publications (267)963.94 Total impact

  • Clinica chimica acta; international journal of clinical chemistry 08/2015; DOI:10.1016/j.cca.2015.08.007 · 2.76 Impact Factor
  • Clinical Chemistry and Laboratory Medicine 05/2015; DOI:10.1515/cclm-2015-0355 · 2.96 Impact Factor
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    ABSTRACT: Serum human epididymis protein 4 (HE4), a novel tumour marker of ovarian cancer, has been reported to be influenced by some biological factors as body mass index (BMI). Accordingly, we enrolled 103 women without history or current ovarian disease or other gastrointestinal/gynaecological benign or malignant diseases, no smokers, aged ≤55 years and with serum creatinine concentrations ≤0.96 mg/dL and a BMI ranging from 19 to 57 kg/m2. Enrolled subjects underwent HE4 and carbohydrate antigen (CA) 125 measurements by Roche Diagnostics assays. Multiple regression models were used to estimate the potential influence on HE4 and CA 125 concentrations of BMI, age, serum creatinine, menopausal status, menstrual cycle phase and use of oral contraceptives. Age and creatinine increases induced HE4 increase, whereas the use of oral contraceptives appeared to decrease marker concentrations. BMI, as well as menopausal status and menstrual cycle phase, did not influence HE4 concentrations. None of the tested factors influenced CA 125 concentrations. Copyright © 2015. Published by Elsevier B.V.
    Clinica chimica acta; international journal of clinical chemistry 04/2015; 446. DOI:10.1016/j.cca.2015.04.028 · 2.76 Impact Factor
  • Mauro Panteghini · Sverre Sandberg
    Clinical Chemistry and Laboratory Medicine 04/2015; DOI:10.1515/cclm-2015-0303 · 2.96 Impact Factor
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    Federica Braga · Ilenia Infusino · Mauro Panteghini
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    ABSTRACT: The measurement uncertainty budget should combine the uncertainty of higher order references, the uncertainty of commercial system calibration, the system imprecision and individual laboratory performance in terms of variability. Here we recommend that no more than one third of the total uncertainty budget, established by appropriate analytical performance specifications, is consumed by the uncertainty of references and approximately 50% of the total budget consumed by the manufacturer's calibration and value transfer protocol. The remaining 50% should be available for the commercial system imprecision (including the batch to batch variation of the reagents) and individual laboratory performance in order to fulfil the uncertainty goal. For commercial systems to work properly, in vitro diagnostics (IVD) manufacturers will need to take more responsibility and ensure the traceability of the combination of platform, reagents, calibrators and control materials for system alignment verification that only as such (as a whole) are certified ("CE marked") by the manufacturer itself in terms of traceability to the selected reference measurement system. Particularly, IVD manufacturers should report the combined (expanded) uncertainty associated with their calibrators when used in conjunction with other components of their analytical system (platform and reagents). This is more than what they are currently providing as traceability and uncertainty information.
    Clinical Chemistry and Laboratory Medicine 04/2015; 53(6). DOI:10.1515/cclm-2014-1240 · 2.96 Impact Factor
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    ABSTRACT: As a part of an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) project to prepare a commutable reference material for cardiac troponin I (cTnI), a pilot study evaluated current cTnI assays for measurement equivalence and their standardization capability. cTnI-positive samples collected from 90 patients with suspected acute myocardial infarction were assessed for method comparison by 16 cTnI commercial assays according to predefined testing protocols. Seven serum pools prepared from these samples were also assessed. Each assay was assessed against median cTnI concentrations measured by 16 cTnI assays using Passing-Bablok regression analysis of 79 patient samples with values above each assay's declared detection limit. We observed a 10-fold difference in cTnI concentrations for lowest to highest measurement results. After mathematical recalibration of assays, the between-assay variation for patient samples reduced on average from 40% to 22% at low cTnI concentration, 37%-20% at medium concentration, and 29%-14% at high concentration. The average reduction for pools was larger at 16%, 13% and 7% for low, medium and high cTnI concentrations, respectively. Overall, assays demonstrated negligible bias after recalibration (y-intercept: -1.4 to 0.3 ng/L); however, a few samples showed substantial positive and/or negative differences for individual cTnI assays. All of the 16 commercial cTnI assays evaluated in the study demonstrated a significantly higher degree of measurement equivalence after mathematical recalibration, indicating that measurement harmonization or standardization would be effective at reducing inter-assay bias. Pooled sera behaved similarly to individual samples in most assays.
    Clinical Chemistry and Laboratory Medicine 04/2015; 53(5):677-690. DOI:10.1515/cclm-2014-1197 · 2.96 Impact Factor
  • Simona Ferraro · Silvia Corona · Francesco Lavarra · Mauro Panteghini
    Clinical Chemistry and Laboratory Medicine 03/2015; DOI:10.1515/cclm-2015-0131 · 2.96 Impact Factor
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    Clinical Chemistry and Laboratory Medicine 02/2015; DOI:10.1515/cclm-2015-0067 · 2.96 Impact Factor
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    ABSTRACT: Laboratory diagnostics develop through different phases that span from test ordering (pre-preanalytical phase), collection of diagnostic specimens (preanalytical phase), sample analysis (analytical phase), results reporting (postanalytical phase) and interpretation (post-postanalytical phase). Although laboratory medicine seems less vulnerable than other clinical and diagnostic areas, the chance of errors is not negligible and may adversely impact on quality of testing and patient safety. This article, which continues a biennial tradition of collective papers on preanalytical quality improvement, is aimed to provide further contributions for pursuing quality and harmony in the preanalytical phase, and is a synopsis of lectures of the third European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)-Becton Dickinson (BD) European Conference on Preanalytical Phase meeting entitled ‘Preanalytical quality improvement. In pursuit of harmony’ (Porto, 20–21 March 2015). The leading topics that will be discussed include unnecessary laboratory testing, management of test request, implementation of the European Union (EU) Directive on needlestick injury prevention, harmonization of fasting requirements for blood sampling, influence of physical activity and medical contrast media on in vitro diagnostic testing, recent evidence about the possible lack of necessity of the order of draw, the best practice for monitoring conditions of time and temperature during sample transportation, along with description of problems emerging from inappropriate sample centrifugation. In the final part, the article includes recent updates about preanalytical quality indicators, the feasibility of an External Quality Assessment Scheme (EQAS) for the preanalytical phase, the results of the 2nd EFLM WG-PRE survey, as well as specific notions about the evidence-based quality management of the preanalytical phase.
    Clinical Chemistry and Laboratory Medicine 12/2014; DOI:10.1515/cclm-2014-1051 · 2.96 Impact Factor
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    ABSTRACT: At least one in 10 patients experience adverse events while receiving hospital care. Many of the errors are related to laboratory diagnostics. Efforts to reduce laboratory errors over recent decades have primarily focused on the measurement process while pre- and post-analytical errors including errors in sampling, reporting and decision-making have received much less attention. Proper sampling and additives to the samples are essential. Tubes and additives are identified not only in writing on the tubes but also by the colour of the tube closures. Unfortunately these colours have not been standardised, running the risk of error when tubes from one manufacturer are replaced by the tubes from another manufacturer that use different colour coding. EFLM therefore supports the worldwide harmonisation of the colour coding for blood collection tube closures and labels in order to reduce the risk of pre-analytical errors and improve the patient safety.
    Clinical Chemistry and Laboratory Medicine 10/2014; 53(3). DOI:10.1515/cclm-2014-0927 · 2.96 Impact Factor
  • Simona Ferraro · Mauro Panteghini
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    ABSTRACT: Abstract The availability of so-called high-sensitivity troponin assays (hsTn) has scored a compelling goal for laboratory medicine, allowing the safe clinical application of international recommendations for the definition of acute myocardial infarction (AMI). However, the introduction of hsTn has not been welcomed by clinicians, claiming an increase in false-positive results. Here we critically trace back the steps following the introduction of hsTn by referring to the 5-year practical experience in our academic hospital and to suitable information available in the literature. In agreement with published data, we found that hsTn introduction was associated with an increased number of AMI diagnoses, whereas the test volume, the revascularization rate, and the proportion of cases with negative angiography findings remained virtually unchanged. Fast-track protocols for ruling out AMI have been further optimized to recommend sampling at presentation and after 3 h only. We focus on a cost-effective use of hsTn that can account for all clinical variables increasing the pre-test probability in order to ensure that tests are ordered only for patients at medium to high risk for acute coronary syndrome (ACS). To guide interpretation of results, hsTn typical release patterns suggestive for AMI should be identified by evaluating the significance of concentration changes. hsTn have markedly shortened the time to rule out or rule in AMI and has the potential to improve the prognostic assessment of critical patients in clinical contexts different from ACS.
    Clinical Chemistry and Laboratory Medicine 10/2014; 53(5). DOI:10.1515/cclm-2014-0812 · 2.96 Impact Factor
  • Simona Ferraro · Domitilla Schiumarini · Mauro Panteghini
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    ABSTRACT: Background: Amongst the newly proposed biomarkers for ovarian cancer, serum human epididymis protein 4 (HE4) shows the greatest potential for clinical use. However, systematic appraisals of its biological characteristics are not available. This study sought to critically revise the available literature on biological and lifestyle factors affecting HE4 concentrations in serum to understand their possible influence on the marker interpretation. Methods: A literature search was undertaken on electronic databases and references from retrieved articles. Article results were analyzed by evaluating study design, sample size, statistical approach, employed assay and, when available, by collecting similar information for carbohydrate antigen 125 (CA-125). Results: Several factors may influence serum HE4 concentrations. In contrast to CA-125, higher HE4 concentrations are reported in the elderly. Although no variations in HE4 concentrations can be clearly associated to menopausal status, a strong difference in biomarker biological intra-individual variation according to the fertility status is reported. Smoking and renal function can also significantly influence HE4 results. Conclusion: The knowledge of factors influencing HE4 concentrations is relevant to promote more adequate interpretative criteria for use of this biomarker in the clinical setting.
    Clinica Chimica Acta 08/2014; 438. DOI:10.1016/j.cca.2014.08.020 · 2.82 Impact Factor
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    Clinical Chemistry 08/2014; 61(2). DOI:10.1373/clinchem.2014.230300 · 7.77 Impact Factor
  • Federica Braga · Simona Ferraro · Roberta Mozzi · Mauro Panteghini
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    ABSTRACT: Abstract Background: An increased focus on the biological behaviour of serum biomarkers for ovarian cancer, i.e., carbohydrate antigen 125 (CA-125) and human epididymis protein 4 (HE4), has been advocated to improve their clinical use. Due to the paucity and poor design of available studies evaluating biological variation (BV) of CA-125 and the lack of BV data for HE4, in this study we evaluated BV of both biomarkers. Methods: Monthly we obtained serum samples from 14 pre- (PreM) and 14 post-menopausal (PostM) healthy women for 4 consecutive months. Once all samples were available, they were analysed in a single run in duplicate for CA-125 and HE4 on Roche Modular system. Data were analysed by ANOVA. Results: For both biomarkers no difference in median concentrations was found between PreM and PostM. For CA-125 the intra-individual CV (CVI) was not different between groups (9.1% in both). For HE4 CVI was higher in PreM (12.1%) than in PostM (6.5%) (p<0.001). Between-subject CVs were 10.6% for CA-125 and 16.4% for HE4, with no influence by the fertility status. Both biomarkers showed high individuality meaning that the use of population-based reference limits may have limited value for their interpretation. Reference change values were 26% for CA-125 (all), 34% for HE4 PreM and 18% for HE4 PostM. Conclusions: Monitoring longitudinal changes in serum concentrations of ovarian cancer biomarkers over time is probably better than using single threshold rules. According to differences in BV due to the hormonal status, one should differently interpret HE4 changes in PreM and PostM.
    Clinical Chemistry and Laboratory Medicine 05/2014; 52(11). DOI:10.1515/cclm-2014-0097 · 2.96 Impact Factor
  • Federica Braga · Mauro Panteghini
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    ABSTRACT: Abstract Glycated hemoglobin (HbA1c) plays a key role in diagnosing diabetes and monitoring the glycemic state. To guarantee the reliability of its measurement at the global level, the IFCC has defined a reference measurement system, based on the definition of the measurand as hemoglobin molecules having a special hexapeptide in common, which is the stable adduct of glucose to the N-terminal valine of the hemoglobin β-chain. In addition to the traceability of HbA1c results to the reference system, the establishment of analytical goals to make HbA1c measurements clinically reliable becomes crucial. However, allowable goals will depend on the assay specificity (i.e., selectivity) and, consequently, on units in which HbA1c results are expressed [mmol/mol for IFCC-aligned systems or % for National Glycohemoglobin Standardization Program (NGSP) converted numbers]. In this regard, analytical goals derived from biological variability studies in which the determination of HbA1c has been carried out by an assay providing the same selectivity for the measurand as defined by the IFCC are recommended. Only these targets should be used for evaluating the performance of commercial assays traceable to the IFCC system and of clinical laboratories using them through appropriately structured quality assessment schemes. Analytical systems following different calibration hierarchies (e.g., the NGSP-aligned assays) will require different analytical goals, possibly derived from clinical outcome data.
    Clinical Chemistry and Laboratory Medicine 05/2014; 52(5):759. DOI:10.1515/cclm-2014-5001 · 2.96 Impact Factor
  • Jillian R Tate · Roger Johnson · Julian H Barth · Mauro Panteghini
    Clinica chimica acta; international journal of clinical chemistry 02/2014; 432. DOI:10.1016/j.cca.2014.02.006 · 2.76 Impact Factor
  • Federica Braga · Ilenia Infusino · Alberto Dolci · Mauro Panteghini
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    ABSTRACT: Determination of serum soluble transferrin receptor (sTfR) has been proposed to identify iron-deficiency anemia (IDA) in patients affected by concurrent inflammatory disease that may spuriously increases ferritin concentration. The aim of this study was to critically review the available literature to assess the diagnostic efficacy of sTfR in complicated anemia. The criteria for study selection were: enrolment of patients with complicated anemia; bone marrow examination used as diagnostic gold standard for IDA; evaluation of sTfR vs. ferritin and binary data presentation. Six published studies met the criteria. However, small size and wide heterogeneity of the studies did not allow us to conduct a meta-analysys. sTfR was overall more sensitive, even though it was evident that the ferritin sensitivity was influenced by selected cut-offs. Well-designed studies are still needed to define the added value, if any, of sTfR to ferritin for IDA detection in complicated anemia.
    Clinica chimica acta; international journal of clinical chemistry 02/2014; DOI:10.1016/j.cca.2014.02.005 · 2.76 Impact Factor
  • Dominika Szoke · Cristina Valente · Mauro Panteghini
    Clinical Chemistry and Laboratory Medicine 01/2014; 52(5):1-3. DOI:10.1515/cclm-2013-1006 · 2.96 Impact Factor
  • Simona Ferraro · Roberta Mozzi · Mauro Panteghini
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    ABSTRACT: Abstract 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 far-reaching 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.
    Clinical Chemistry and Laboratory Medicine 12/2013; 52(6):1-11. DOI:10.1515/cclm-2013-0738 · 2.96 Impact Factor
  • Federica Braga · Mauro Panteghini
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    ABSTRACT: To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their analytical performance should fulfil acceptable measurement uncertainty criteria defined to fit the intended clinical use. With this aim, In Vitro Diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators and to fulfil during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for laboratory results. It is important that end-users may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. However, full information about traceability and combined uncertainty of calibrators is currently not available. Important tools for IVD traceability surveillance are the verification by laboratories of the consistency of declared performance during daily operations performed in accordance with the manufacturer's instructions and the organization of appropriately structured External Quality Assessment (EQA) programs. The former activity should be accomplished by analyzing system control materials and confirming that current measurements are in the manufacturer's established control range. With regard to EQA, it is mandatory that target values for materials are assigned with reference procedures by accredited laboratories, that materials are commutable and a clinically allowable inaccuracy for participant's results is defined.
    Clinica chimica acta; international journal of clinical chemistry 11/2013; 432. DOI:10.1016/j.cca.2013.11.022 · 2.76 Impact Factor

Publication Stats

5k Citations
963.94 Total Impact Points


  • 2007–2015
    • Ospedale Luigi Sacco
      Milano, Lombardy, Italy
    • Royal Brisbane Hospital
      • Department of Chemical Pathology
      Brisbane, Queensland, Australia
  • 2002–2014
    • University of Milan
      • Department of Biomedical and Clinical Sciences "Luigi Sacco"
      Milano, Lombardy, Italy
    • University of Bonn
      Bonn, North Rhine-Westphalia, Germany
  • 2011–2012
    • Azienda Ospedaliera Universitaria Luigi Sacco
      Milano, Lombardy, Italy
  • 1984–2005
    • Spedali Civili di Brescia
      • Laboratorio di Analisi Chimico-Cliniche
      Brescia, Lombardy, Italy
  • 1986–2004
    • Università degli Studi di Brescia
      Brescia, Lombardy, Italy
  • 2001
    • University of Maryland, Baltimore
      • Department of Pathology
      Baltimore, Maryland, United States
  • 1983
    • Civil Hospital, Raikot
      Rāikot, Punjab, India