Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
☩Howard Morris Australia
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
☩Jill Tate Australia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

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Giuseppe Agosta

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Arianna Lucini Paioni
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Biochimica Clinica: VOL.37 N.1

Procalcitonina: tra evidenze e criticità
Procalcitonin: between evidence and critical issues
Biochimica Clinica 2013; 37(1) 12-14
Editoriale - Editorial
Procalcitonina e sepsi: alcuni aspetti relativi all’appropriatezza della richiesta
Procalcitonin and sepsis: hints on clinical appropriateness

Sepsis in know to be a challenge for clinicians, given the poor outcome and high costs. Both diagnosis and management are a matter of concern, as appropriate and early therapy can result in higher survival rate. Various biological parameters have been proposed to establish diagnosis
and evaluate risk. Procalcitonin (PCT), the precursor of calcitonin, has gained attention as serological marker of sepsis and several authors have claimed for PCT a role in rapid diagnosis as well as risk stratification and prognosis evaluation. Data from systematic reviews support the use of PCT as an alternative to C-reactive protein in adult intensive care unit patients, although its use as sole diagnostic marker does not appear to be appropriate in critical patients. In the emergency department setting PCT can be used to rule out sepsis in adult febrile patients. Data on risk stratification and prognosis are less clear cut and specific clinical questions need further investigation.

Biochimica Clinica 2013; 37(1) 15-22
Rassegne - Reviews
Increasing efficiency and quality by automation and consolidation of tests: the experience of a hospital-based laboratory
S. Valverde  |  L. Penzo  |  G. Gessoni  | 

In this study we evaluated efficiency and quality in our laboratory after the implementation of total laboratory automation for clinical chemistry and immunochemistry assays. Thermo EnGen pre-analytical automation with a track system connecting two Vitros Fusion 5.1 and two Tosoh AIA-2000 analyzers were implemented. For Vitros Fusion 5.1, CVs were <8% (within-run) and <10% (inter-assay), except for measurement of anti-streptolysin O titre (CV 22.7%-27.7%). For Tosoh AIA-2000 analyzers, within-run CVs were <10% and between-run CVs <11%. No drift effects were observed, neither there was any carry-over. When evaluating the functionality of the whole automation system, we observed a turnaround time (TAT) 90% <10 min for tubes needing check-in and exit only. For tubes needing check-in and centrifugation – exit cycle, TAT 90% was <30 min. Result availability for clinical chemistry and/or immunochemistry on-line analyzers showed a TAT 90% <120 min. The adopted automation system effectively reduced the labor associated with specimen processing, possibly decreasing the number of laboratory errors that occur with specimen sorting, labeling and aliquoting, and improved the integrity of specimen handling throughout steps of specimen processing.

Biochimica Clinica 2013; 37(1) 23-29
Contributi Scientifici - Scientific Papers
Valutazione multicentrica dell’analizzatore Tosoh G8 per la misura dell’emoglobina A2 e dell’emoglobina F
Multicenter evaluation of the Tosoh G8 analyzer for determination of hemoglobin (Hb) A2 and F

The analytical performance of the new Tosoh automated analyzer HLC-723 G8 (-thalassemia analysis mode) to determine hemoglobin variants and to measure HbA2 and HbF in human blood was evaluated in three Italian centres. The within- and between-run imprecision for HbA2 were good, with CV between 0.2% and 1.8% and between 0.9% and 5.4%, respectively. The CV for HbF was between 0.4% and 9.8% (within-run) and beetwen 0.8% and 13.1% (between-run). The comparability of HbA2 measurements between different centres was excellent (r=0.99), but a significant bias in comparison with the previous version of the instrument was noted. Experiments to test the HbA2 stability in blood confirmed that blood samples stored at -80 °C were stable for at least 4 months and that storage at -20 °C is not recommended. In conclusion, the Tosoh G8 analyser was found reliable and robust and, therefore, suitable for the measurement of HbA2 and HbF in human blood.

Biochimica Clinica 2013; 37(1) 30-35
Contributi Scientifici - Scientific Papers
Efficacia della misura della troponina T con metodo ad alta sensibilità nella diagnosi precoce di infarto acuto del miocardio
Effectiveness of highly sensitive troponin T assay for early diagnosis of acute myocardial infarction (AMI)

The interpretation of cardiac troponin results has become challenging because of the availability of highly sensitive troponin assays able to detect even small cardiac damage. To investigate whether the highly sensitive cardiac troponin T assay (hs-cTnT) improves early AMI detection, a comparative evaluation between hs-cTnT and the 4th generation assay (4th-cTnT) was performed. Patients who presented to the Emergency Department from June to September 2011 with chest pain were recruited. Blood samples were taken at admission (T0), 1 (T1), 3, 6 and 12 h after presentation and were analysed by 4th-cTnT and hs-cTnT using Modular SWA E170 analyzer (Roche Diagnostics). For this study, only samples at T0 and T1 were evaluated. Of the 386 patients recruited, 32 (8.3%) had AMI. The sensitivity of hs-cTnT at T0 was 72% vs. 50% of 4th-cTnT. In T1 samples the sensitivity of hs-cTnT (97%) was slightly higher than 4th-cTnT (78%) (P=0.06). Our preliminary results showed that hs-cTnT can detect AMI 1 h after the hospital arrival in the majority of patients. Ongoing studies will define best algorithms for the effective use of hs-cTnT results in clinical practice. Rule-out and rule-in algorithms will have to be fine tuned to exploit cost-savings associated with this early diagnostic accuracy.

Biochimica Clinica 2013; 37(1) 36-39
Contributi Scientifici - Scientific Papers
Etica e metodologia di scrittura di un lavoro scientifico
Publication ethics and scientific writing

Ethic issues and the structure of manuscripts are two main aspects when writing a research paper in the biomedical field with the aim to submit it to a scientific journal for publication. Considering publication ethics, the integrity of the scientific writing is under the responsibility of authors, reviewers, and editor of the journal and should be maintained across the entire process of publication. The authors’ responsibility includes unequivocal transgression (falsification of data, plagiarism, authorship, conflict of interest), which cannot be tolerated, and undesirable practice (self plagiarism, redundant publication) as well. The reviewers’ responsibility includes conflict of interest and confidentiality. Among the journal editor’s responsibilities, there are conflict of interest, publication bias, willingness of publishing complaints, clarifications and apologies. A scientific article should usually have a definite structure, made up of different sections. Here suggestions are given on how to find an appealing “Title”, how to prepare a comprehensive “Abstract”, how to cope with the “Introduction”, how to improve the description of employed “Methods”, how to present data in the “Results” section, and how to better organize the results “Discussion”. Our experience as editors of this journal suggests that our colleagues should be more aware of both ethical aspects and correct procedures to follow before starting to write a scientific paper in order to prevent the rejection of their work.

Biochimica Clinica 2013; 37(1) 40-47
Opinioni - Opinions
Accuratezza nella misura e impiego clinico dell’esame di laboratorio: l’esempio dell’albumina sierica
Measurement accuracy and clinical use of laboratory tests: the case of serum albumin

Albumin is the major plasma protein and its determination is used for the prognostic assessment of several diseases. Clinical guidelines call for monitoring of serum albumin with specific target cut-offs that are independent of the assay used. This requires accurate and equivalent results among different commercially available methods (i.e., result standardization) through a consistent definition and application of a reference measurement system. This should be associated with the definition of measurement uncertainty goals based on medical relevance of serum albumin to make results reliable for patient management. In this paper, we show that, in the current situation, if one applies the analytical goals for serum albumin measurement derived from its biologic variation, the uncertainty budget derived from each step of the albumin traceability chain is probably too high to fulfil the established quality levels for albumin measurement and to guarantee the accuracy needed for clinical usefulness of the test. The situation is further worsened if non-specific colorimetric methods are used for albumin measurement as they represent an additional random source of uncertainty.

Biochimica Clinica 2013; 37(1) 48-52
Opinioni - Opinions
Biomarcatori e accertamento del rischio cardiovascolare per la prevenzione primaria: un aggiornamento
Biomarkers and Cardiovascular Risk Assessment for Primary Prevention: An Update

Interest in cardiovascular biomarkers in primary prevention has increased dramatically in the past decade. This increase has been fueled by an improved understanding of cardiovascular pathophysiology, as well as novel technologies for biomarker identification. In this review we provide a brief overview of recent concepts in the evaluation of screening biomarkers, because biomarkers may behave differently when used for screening as opposed to diagnosis or disease staging. The following specific biomarker examples are then discussed, with a focus on data from primary prevention studies: high-sensitivity C-reactive protein, B-type natriuretic peptide, lipoprotein-associated phospholipase A2, and high-sensitivity troponin T. The article concludes by addressing novel platforms for biomarker discovery, reviewing recent examples from the field of metabolomics. An ongoing challenge is to develop screening strategies that can identify individuals at risk for cardiovascular events well before symptoms appear. For this purpose, the measurement of soluble biomarkers could be an important adjunct to traditional cardiovascular risk assessment. Recent studies highlight both the strengths and limitations of “novel” circulating biomarkers, and suggest that substantial work is still needed to identify biomarkers that are sufficiently accurate and cost-effective for routine use in primary prevention.

Biochimica Clinica 2013; 37(1) 53-63
Il meglio di Clinical Chemistry - Clinical Chemistry highlights
Una gammopatia monoclonale di difficile tipizzazione
A monoclonal gammopathy of difficult characterization
F. Gulli  |  U. Basile  |  S. Borrello  |  C. Zuppi  | 

IgD monoclonal gammopathy is a rare event, but its recognition and management are quite important because the condition is potentially life-threatening. This paper reports a peculiar case of IgD monoclonal gammopathy. The monoclonal protein was rapidly degraded by proteolysis and the usual laboratory tests showed different immunochemical patterns. The study of the proteolitic dynamic of the monoclonal immunoglobulin allowed us to obtain the complete characterization of the monoclonal component.

Biochimica Clinica 2013; 37(1) 64-67
Casi Clinici - Case Report
EuroMedLab 2013 News
Biochimica Clinica 2013; 37(1) 68-71
Notizie SIBioC - SIBioC News