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Editor-in-chief
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

EIC Assistant
Francesco Busardò

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
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da R. Mozzi

Determinazione della vitamina B12 nel siero: indicazioni per la richiesta e l’interpretazione dei risultati
Determination of vitamin B12 in serum: recommendations for test request and result interpretation
S. Ferraro \| A. Dolci \| R. Mozzi \| M. Panteghini \|
<p>The measurement of vitamin B<sub>12</sub> (B12) in serum has an overall poor capability to rule out subjects for B12 deficiency. Furthermore, trying to identify those subjects by resorting to one solely test threshold level (e.g., the lower reference limit) may mislead the clinical diagnosis. Clinical laboratories should therefore optimize the test interpretation by replacing in their report the standard reference interval with a categorization of risk for B12 deficiency. Accordingly, a B12 concentration <100 ng/L may indicate a probable B12 deficiency and the need for vitamin supplementation. A possible or unlikely deficiency may be associated with marker results, respectively, below and above 300 ng/L. Finally, in subjects with B12 concentrations >400 ng/L, the vitamin deficiency may be excluded. Hemodialysis patients and pregnant woman have emerged as a target for B12 testing, although cost-effectiveness evaluations are difficult to perform in absence of reliable literature data. Monitoring B12 concentrations in serum to evaluate the effectiveness of B12 supplementation is not clinically useful.</p>
Biochimica Clinica ; 38(4) 326-329 Documenti - Documents

Cancer biomarkers 2013: appunti a margine del convegno satellite EuroMedLab
Cancer biomarkers 2013: notes about the EuroMedLab satellite meeting
S. Ferraro \| R. Mozzi \| M. Panteghini \|
<p>Like all other interventions and devices in health care, cancer biomarkers should undergo a careful validation process before they are introduced into clinical practice for diagnostic or prognostic purposes. Particularly, for those candidate diagnostic markers, validation implies the assessment of their diagnostic accuracy according to pre-specified and standardized criteria. For prognostic purposes, large, protocol-driven prospective studies should assure unbiased results on the effectiveness of the investigated biomarkers in predicting patient’s risk of a future outcome, in aiding individual treatment choice and in patient counselling. The improvement of the methodology of research should finally contribute evidence of high level and strength useful to recommend or not the appropriate application of specific biomarkers in different clinical settings (screening, primary/secondary care, treatment monitoring, follow-up). In this presentation, we summarized the major issues highlighted during the recent EuroMedLab satellite meeting held in Venice (IT) on May 2013, in which standardized processes from the evaluation of biomarkers’ diagnostic accuracy and prognostic value for guideline development were discussed. In addition, current efforts on the research of novel molecules and therapeutic targets (proteins, exosomes, circulating nucleic acids) candidate to clinical introduction were briefly reviewed.</p>
Biochimica Clinica ; 37(6) 479-492 Opinioni - Opinions

Un raro caso di mesotelioma multicistico del peritoneo associato ad aumento di CA 125 e CA 19.9 nel siero
A rare case of benign multicystic mesothelioma of the peritoneum associated to CA 125 and CA 19.9 elevations in serum
S. Ferraro \| R. Mozzi \| C. Villa \| M. Crespi \| M. Panteghini \|
<p>Markedly increased CA 125 and CA 19.9 concentrations in serum are considered specific enough to reliably identify malignant cancers (ovarian and gastrointestinal tumours, respectively), although a consistent body of literature has reported marker elevations in several benign conditions. Here we report the case of a woman in post-menopausal status, with a previous history of hysterectomy, presenting with a 12-cm pelvic mass at sonography and serum CA 125 and CA 19.9 concentrations >400 kU/L. One month after initial presentation, she underwent surgical evaluation for laparoscopy, repeating marker determinations. Concentrations of CA 125 and CA 19.9 were still elevated, but decreased if compared with the previous data (~200 kU/L). Magnetic resonance imaging characterized a multicystic mass in the mesentery, allowing to hypothesize a benign multicystic mesothelioma of the peritoneum (BMMP). The laparoscopy revealed multiple cysts, some of them resulting in colliquation, associated to ascites. Histological examination of biopsy specimens confirmed BMMP as composed of multiple, thin-walled, irregularly spaced cysts lined by flattened and cuboidal mesothelial cells. The cystic colliquation was though as the main cause for decrease in marker concentrations. To our knowledge, this is the first case of BMMP associated with significantly increased concentrations of CA 125 and CA 19.9 and their decrease before any surgical treatment.</p>
Biochimica Clinica ; 37(3) 241-245 Casi Clinici - Case Report

Rilevazione, monitoraggio e trattamento di non conformità nella fase preanalitica: l’esperienza di un ospedale universitario metropolitano
Recording, monitoring, and managing pre-analytical issues in a metropolitan university hospital
R. Mozzi \| A. Carnevale \| C. Valente \| A. Dolci \| M. Panteghini \|
<p>Errors in laboratory testing process may have an adverse impact on patient care. The pre-analytical phase is responsible for ~70% of these errors. In this study we present our experience in assessing the frequency of pre-analytical errors in our university hospital, by monitoring their trend over time and comparing data with goals suggested in literature. The impact of corrective actions, if any, was also checked. A comprehensive retrospective analysis of pre-analytical nonconformities (NC) recorded through laboratory information system over a 5-year (2007-2011) time span was undertaken. Retrieved data were evaluated on a yearly basis, first for NC type and then for type of sample, laboratory section and hospital department involved. The relatively most frequent NC was the test request without the corresponding sample, accounting on average for 2.3% of all requested tests. Hemolysis occurred for in average 1.15% of all requested tests, affecting ~20,000 determinations per year, mostly interesting clinical wards taking care of critical patients, i.e. neonatology, oncology, and emergency department. Clotted and not sufficient samples showed a significant reduction over time after changing the analytical system measuring erythrocyte sedimentation rate and adopting more reliable tubes, easier to fill in and mix up. NC related to samples conveyed at wrong temperature were also relatively frequent. Our results show that recording, monitoring, and critically evaluating pre-analytical issues in laboratory testing process is mandatory for providing a good laboratory service, permitting to identify causes of NC and to apply corrective interventions that may help to reduce their incidence.</p>
Biochimica Clinica ; 37(2) 095-099 Contributi scientifici - Scientific Papers

Un ulteriore passo verso una migliore efficienza ed efficacia della determinazione della calprotectina fecale
A further step to improve the cost-effectiveness of calprotectin determination
S. Ferraro \| R. Mozzi \| M. Panteghini \|

Biochimica Clinica ; 37(2) 133-134 Lettere all'Editore - Letters to the Editor

Frequenza e significato clinico di valori di antigene carboidratico (CA) 19.9 marcatamente elevati in una popolazione di pazienti ospedalizzati
Prevalence and clinical significance of enormously increased carbohydrate antigen (CA) 19.9 concentrations in hospitalised patients
R. Mozzi \| S. Ferraro \| C. Valente \| M. Panteghini \|
<p style="text-align: justify;">Markedly elevated CA 19.9 concentrations in serum are regarded as specific enough to reliably identify pancreatic cancer, even if a consistent body of literature shows CA 19.9 concentrations >1000 kU/L in a variety of benign conditions. Scarce data are, however, available on the prevalence and clinical significance of CA 19.9 values >10,000 kU/L. Here we present a case series of 18 consecutive patients admitted to our hospital in a time period of 14 months showing an enormous elevation of CA19.9 concentrations (11,568 to >100,000 kU/L), with the aim to assess the association of such concentrations with the presence of pancreatic cancer and, more in general, with tumours of the gastrointestinal system. We also tried to define whether the exact measurement of CA 19.9 concentrations in this range, which needs serial sample dilutions, is cost-effective. CA 19.9 measurements, including sample dilutions according to a defined laboratory protocol, were performed on Roche Modular EVO system. The yearly prevalence of hospitalized patients tested for CA 19.9 and with marker concentrations >10,000 kU/L was 2.9%. All recruited patients were diagnosed as malignancies: 15 had primary or secondary pancreatic cancer, two had gastric cancer, and one a cholangiocarcinoma. CA 19.9 concentrations ranged between >10,000-30,000 kU/L in 9 cases, >30,000-60,000 kU/L in two, >60,000-100,000 kU/L in three, and >100,000 kU/L in four cases, respectively. A surgical resection of the tumour was performed in five patients, independently of CA 19.9 concentrations. The median patient’s survival was <6 months. In conclusion, CA 19.9 concentrations >10,000 kU/L unequivocally identify a gastrointestinal malignancy, more frequently (~83%) a primary or secondary pancreatic cancer. Exactly measuring CA 19.9 concentrations >10,000 kU/L after multiple sample dilution does not add relevant information for patients’ prognosis and treatment.</p>
Biochimica Clinica ; 36(6) 436-440 Casi Clinici - Case Report