Mauro Panteghini

Ospedale Luigi Sacco, Milano, Lombardy, Italy

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Publications (328)1027.56 Total impact

  • Federica Braga · Mauro Panteghini
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    ABSTRACT: In recent decades, the study of biological variation of laboratory analytes has received increased attention. The reasons for this interest are related to the potential practical applications of such knowledge. Biological variation data allow the derivation of important parameters for the interpretation and use of laboratory tests, such as the index of individuality for the evaluation of the utility of population reference intervals for the test interpretation, the estimate of significant change in a timed series of results of an individual, the number of specimens required to obtain an accurate estimate of the homeostatic set point of the analyte, and analytical performance specifications that assays should fulfil for their application in the clinical setting. It is, therefore, essential to experimentally derive biological variation information in an accurate and reliable way. Currently, a dated guideline for the biological variation data production and a more recent checklist to assist in the correct preparation of publications related to biological variation studies are available. Here we update and integrate, with examples, the available guideline for biological variation data production to help researchers to comply with the recommendations of the checklist for drafting manuscripts on biological variation. Particularly, we focus on the distribution of the data, an essential aspect to be considered for the derivation of biological variation data. Indeed, the difficulty in deriving reliable estimates of biological variation for those analytes, the measured concentrations of which are not normally distributed, is more and more evident.
    No preview · Article · Feb 2016 · Critical Reviews in Clinical Laboratory Sciences
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    ABSTRACT: To evaluate the impact of age- and gender-specific cut-offs for high-sensitivity cardiac troponin T (hs-cTnT) compared to the general 99th percentile hs-cTnT cut-off on diagnosis and prognosis of acute myocardial infarction (AMI).
    No preview · Article · Feb 2016
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    ABSTRACT: Study objective: We aim to prospectively validate the diagnostic accuracy of the recently developed 0-h/1-h algorithm, using high-sensitivity cardiac troponin T (hs-cTnT) for the early rule-out and rule-in of acute myocardial infarction. Methods: We enrolled patients presenting with suspected acute myocardial infarction and recent (<6 hours) onset of symptoms to the emergency department in a global multicenter diagnostic study. Hs-cTnT (Roche Diagnostics) and sensitive cardiac troponin I (Siemens Healthcare) were measured at presentation and after 1 hour, 2 hours, and 4 to 14 hours in a central laboratory. Patient triage according to the predefined hs-cTnT 0-hour/1-hour algorithm (hs-cTnT below 12 ng/L and Δ1 hour below 3 ng/L to rule out; hs-cTnT at least 52 ng/L or Δ1 hour at least 5 ng/L to rule in; remaining patients to the "observational zone") was compared against a centrally adjudicated final diagnosis by 2 independent cardiologists (reference standard). The final diagnosis was based on all available information, including coronary angiography and echocardiography results, follow-up data, and serial measurements of sensitive cardiac troponin I, whereas adjudicators remained blinded to hs-cTnT. Results: Among 1,282 patients enrolled, acute myocardial infarction was the final diagnosis for 213 (16.6%) patients. Applying the hs-cTnT 0-hour/1-hour algorithm, 813 (63.4%) patients were classified as rule out, 184 (14.4%) were classified as rule in, and 285 (22.2%) were triaged to the observational zone. This resulted in a negative predictive value and sensitivity for acute myocardial infarction of 99.1% (95% confidence interval [CI] 98.2% to 99.7%) and 96.7% (95% CI 93.4% to 98.7%) in the rule-out zone (7 patients with false-negative results), a positive predictive value and specificity for acute myocardial infarction of 77.2% (95% CI 70.4% to 83.0%) and 96.1% (95% CI 94.7% to 97.2%) in the rule-in zone, and a prevalence of acute myocardial infarction of 22.5% in the observational zone. Conclusion: The hs-cTnT 0-hour/1-hour algorithm performs well for early rule-out and rule-in of acute myocardial infarction.
    Full-text · Article · Jan 2016 · Annals of Emergency Medicine
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    ABSTRACT: Objectives: Increased frequency of hyperamylasemia has previously been reported in human immunodeficiency virus (HIV)-positive patients, but studies determined total amylase activity and were performed before the introduction of highly active antiretroviral therapy (HAART). We evaluated the frequency of pancreatic hyperamylasemia in a large HIV+ population mostly treated with HAART.Methods: The upper reference limit (URL) for pancreatic amylase (P-AMY) was derived from 299 healthy blood donors. A cross-sectional study was then performed on samples obtained from 1,548 consecutive patients referred to our infectious disease clinic to assess serum P-AMY and lipase concentrations. Of the patients, 94% were HIV+, and most (92%) were taking HAART (HIV+Tx+).Results: P-AMY URL was 51 U/L. The frequency of P-AMY increase did not significantly differ between HIV+ and HIV - populations (14.2% vs 15.2%, P = .91) or between HIV+Tx+ and HIV+Tx - (14.7% vs 8.9%, P = .11). In almost half (48.3% of HIV+ and 42.9% of HIV -) of hyperamylasemic patients, lipase was normal, indicating a non pancreatic origin of their P-AMY increase. Markedly elevated P-AMY (>3 times the URL) was found in six HIV+ patients and in one HIV - patient: two had macroamylasemia, one acute pancreatitis, three (including the HIV - patient) chronic pancreatitis, and one chronic hyperamylasemia of undefined origin.Conclusions: In our study, both HIV+ and HIV+Tx+ do not show an increased frequency of P-AMY elevation. Frank pancreatic disease is rare in this clinical setting.
    Preview · Article · Jan 2016 · American Journal of Clinical Pathology
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    Mauro Panteghini · Sverre Sandberg

    Full-text · Article · Nov 2015 · Clinical Chemistry and Laboratory Medicine
  • Sara Pasqualetti · Dominika Szőke · Mauro Panteghini
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    ABSTRACT: Background: Pneumatic tube transportation (PTT) may induce hemolysis (H) in blood samples. We aimed to compare the H degree before and after PTT implementation in our hospital. Methods: Hemolysis indices (HI) for all lithium-heparin plasma samples (P) drawn by the Emergency Department in 2-month periods were retrospectively collected and pre- (n=3579) and post-PTT (n=3469) results compared. The impact of PTT introduction was investigated on LDH [HI threshold (HIt), 25], conjugated bilirubin (cBIL) (HIt, 30), K (HIt, 100) and ALT (HIt, 125). In addition, HI retrieved for P and paired serum samples collected in silica clot activator tubes (S) from the same venipuncture were compared in pre- (n=501) and post-PTT (n=509) periods. Results: Median (5-95th percentile) HI in P was significantly higher in post-PTT period [7 (0-112) vs. 6 (0-82), p<0.001]. Results reported as 'Hemolysis' in P increased from 6.6% in pre-PTT to 9.4% in post-PTT (p<0.001). Investigated tests gave the following rejection rates (pre-PTT vs. post-PTT): LDH, 13.4% vs. 18.8%, p<0.001; cBIL, 9.4% vs. 27.0%, p<0.05; K, 3.7% vs. 5.6%, p<0.001; ALT, 2.9% vs. 4.4%, p<0.01. The slightly higher susceptibility to H of S compared to paired P found in the pre-PTT [9 (1-64) vs. 6 (0-85)] was not confirmed in the post-PTT period [7 (0-90) vs. 8 (1-72)], in which median HI in S was significantly lower (p<0.001) than in pre-PTT. Conclusions: In our setting PTT promotes H in P, increasing the rate of rejected tests. The use of S appears to protect against the hemolysing effect of PTT.
    No preview · Article · Oct 2015 · Clinical Chemistry and Laboratory Medicine
  • Simona Ferraro · Federica Braga · Mauro Panteghini
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    ABSTRACT: The 21st century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centred. Although laboratory medicine is integral to many of these objectives involving prevention, diagnosis, treatment, and managing disease of patients, it suffers from poor visibility as a medical discipline and as a profession and fewer rewards for educational efforts when compared to other medical disciplines. Laboratory scientists are often perceived as managing machinery and equipment, but conversely they need to take a position of shared clinical leadership, showing the role of laboratory tests to guarantee optimal care for patients. This is however challenging because of some reluctance by laboratory professionals to involve themselves in test structuring and requesting and in the inspection of work as it arrives because it is assumed that all requests are clinically necessary; there is a poor communication and integration between clinical wards and laboratory; and, importantly, there is the need for an excellent cultural and scientific background of laboratory professionals for implementing outcome research and to act as knowledge managers and skilled clinical consultants. By combining the unique talent of performing quality laboratory assays with knowledge of the pathophysiologic rationale behind the tests, laboratory professionals have the expertise to advise their clinical colleagues in regard to the appropriate test selection and interpretation of laboratory results, thereby creating opportunities to define the added value and the pivotal role of laboratory medicine on healthcare delivery.
    No preview · Article · Oct 2015 · Clinical Chemistry and Laboratory Medicine
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    ABSTRACT: Laboratory medicine is amongst the fastest growing fields in medicine, crucial in diagnosis, support of prevention and in the monitoring of disease for individual patients and for the evaluation of treatment for populations of patients. Therefore, high quality and safety in laboratory testing has a prominent role in high-quality healthcare. Applied knowledge and competencies of professionals in laboratory medicine increases the clinical value of laboratory results by decreasing laboratory errors, increasing appropriate utilization of tests, and increasing cost effectiveness. This collective paper provides insights into how to validate the laboratory assays and assess the quality of methods. It is a synopsis of the lectures at the 15th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine entitled "How to assess the quality of your method?" (Zagreb, Croatia, 24-25 October 2015). The leading topics to be discussed include who, what and when to do in validation/verification of methods, verification of imprecision and bias, verification of reference intervals, verification of qualitative test procedures, verification of blood collection systems, comparability of results among methods and analytical systems, limit of detection, limit of quantification and limit of decision, how to assess the measurement uncertainty, the optimal use of Internal Quality Control and External Quality Assessment data, Six Sigma metrics, performance specifications, as well as biological variation. This article, which continues the annual tradition of collective papers from the EFLM continuing postgraduate courses in clinical chemistry and laboratory medicine, aims to provide further contributions by discussing the quality of laboratory methods and measurements and, at the same time, to offer continuing professional development to the attendees.
    Full-text · Article · Sep 2015 · Clinical Chemistry and Laboratory Medicine
  • Simona Ferraro · Roberta Mozzi · Mauro Panteghini
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    ABSTRACT: Objectives: In this study, we evaluated the extent of inappropriate tumor marker (TM) ordering in a secondary care setting, approximately 6 years after the introduction of local guidelines, and we identified the main factors potentially influencing clinicians when performing an inappropriate TM request. Methods: For this purpose, we regularly checked all requests containing more than two TMs. During the 21-month audit, the rate of rejected requests amounted to 3.6%. Several of those were performed for diagnostic purposes. The most frequent and inappropriately requested TMs were carcinoembryonic antigen and carbohydrate antigen 19.9. Results: The inappropriateness of requests appeared to be linked to the need for more education and knowledge on their clinical applicability and limitations. The clinical motivation was generally associated with patients displaying nonspecific signs/symptoms (ie, weight loss with worsening general conditions), having an incidentally positive result to some recently performed TM tests, or being tested by a TM to avoid more expensive diagnostic imaging procedures. Conclusions: Our data show that real-time control and management of inappropriate requests by laboratory professionals may be relevant to increase the clinical efficacy of TM testing and useful in perspective to drive the introduction of new validated biomarkers.
    No preview · Article · Sep 2015 · American Journal of Clinical Pathology

  • No preview · Article · Sep 2015 · Clinical Chemistry and Laboratory Medicine
  • Federica Braga · Sara Pasqualetti · Simona Ferraro · Mauro Panteghini
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    ABSTRACT: Previous meta-analyses reported no significant or weak association between hyperuricemia (HU) and coronary heart disease (CHD). We updated the literature search, systematically reviewing retrieved papers. The peer-reviewed literature published from 1965 to December 2014 was searched using Medline and Embase. We included prospective cohort studies involving adults (sample size ≥100) with no cardiovascular disease (CVD) and a follow-up of at least 1 year. Studies were excluded if they considered as outcome the CVD incidence/mortality without separately reporting data on CHD, did not adjusted for major confounders and if the 95% confidence interval (CI) for risk ratio (RR) was not available. Relative risk or hazard ratio estimates, with the corresponding CIs, were obtained. For CHD incidence 12 populations were included (457,915 subjects [53.7% males]). For CHD mortality seven populations were included (237,433 subjects [66.3% males]). The overall combined RR were 1.206 (CI 1.066-1.364, p=0.003) for CHD incidence and 1.209 (CI 1.003-1.457, p=0.047) for CHD mortality, respectively. Subgroup analysis showed a marginal (incidence) and not significant (mortality) association between HU and CHD in men, but an increased risk for CHD incidence and mortality in hyperuricemic women (RR 1.446, CI 1.323-1.581, p<0.0001, and RR 1.830, CI 1.066-3.139, p=0.028, respectively). The risk markedly increases for urate concentrations >7.0 mg/dL. HU appears to increase the risk of CHD events in the general population, mainly in adult women. This finding requires, however, further investigation.
    No preview · Article · Sep 2015 · Clinical Chemistry and Laboratory Medicine

  • No preview · Article · Aug 2015 · Clinica chimica acta; international journal of clinical chemistry
  • Federica Braga · Ilenia Infusino · Mauro Panteghini
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    ABSTRACT: To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty as 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 fulfill during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for clinical laboratory results. It is therefore important that, on one hand, the laboratory profession clearly defines the clinically acceptable uncertainty for relevant tests and, on the other hand, endusers may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. Important tools for IVD traceability surveillance are quality control programmes through the daily verification by clinical laboratories that control materials of analytical systems are in the manufacturer’s declared validation range [Internal Quality Control (IQC) component I] and the organization of Exter nal Quality Assessment Schemes meeting metrological criteria. In a separate way, clinical laboratories should also monitor the reliability of employed commercial systems through the IQC component II, devoted to estimation of the measurement uncertainty due to random effects, which includes analytical system imprecision together with individual laboratory performance in terms of variability.
    No preview · Article · Jul 2015 · Journal of Medical Biochemistry

  • No preview · Article · May 2015 · Clinical Chemistry and Laboratory Medicine
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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.
    No preview · Article · Apr 2015 · Clinica chimica acta; international journal of clinical chemistry
  • Mauro Panteghini · Sverre Sandberg

    No preview · Article · Apr 2015 · Clinical Chemistry and Laboratory Medicine
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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.
    Full-text · Article · Apr 2015 · Clinical Chemistry and Laboratory Medicine
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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.
    No preview · Article · Apr 2015 · Clinical Chemistry and Laboratory Medicine
  • Simona Ferraro · Silvia Corona · Francesco Lavarra · Mauro Panteghini

    No preview · Article · Mar 2015 · Clinical Chemistry and Laboratory Medicine
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    Full-text · Article · Feb 2015 · Clinical Chemistry and Laboratory Medicine

Publication Stats

6k Citations
1,027.56 Total Impact Points


  • 2007-2015
    • Ospedale Luigi Sacco
      Milano, Lombardy, Italy
    • Royal Brisbane Hospital
      • Department of Chemical Pathology
      Brisbane, Queensland, Australia
  • 2005-2015
    • University of Milan
      • Department of Biomedical and Clinical Sciences "Luigi Sacco"
      Milano, Lombardy, Italy
  • 2012
    • Università degli Studi del Sannio
      Benevento, Campania, Italy
  • 2011
    • Azienda Ospedaliera Universitaria Luigi Sacco
      Milano, Lombardy, Italy
  • 1984-2005
    • Spedali Civili di Brescia
      • Laboratorio di Analisi Chimico-Cliniche
      Brescia, Lombardy, Italy
  • 1990-2004
    • Università degli Studi di Brescia
      Brescia, Lombardy, Italy
  • 2002
    • University of Bonn
      Bonn, North Rhine-Westphalia, Germany
  • 2001
    • Autonomous University of Barcelona
      • Department of Biochemistry and Molecular Biology
      Cerdanyola del Vallès, Catalonia, Spain
    • University of Maryland, Baltimore
      • Department of Pathology
      Baltimore, Maryland, United States
  • 1983
    • Civil Hospital, Raikot
      Rāikot, Punjab, India