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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 D. Basso

Determinazione di anticorpi anti SARS-CoV-2 in matrice salivare in individui vaccinati e in pazienti COVID-19
Determination of anti-sars-cov-2 antibodies in salivary samples from vaccinated individuals and COVID-19 patients.
C. Cosma \| A. Padoan \| C. Di Chiara \| D. Rinaldi \| D. Donà \| A. Gastaldi \| D. Basso \| C. Giaquinto \| M. Zaninotto \| M. Plebani \|
<p>Introduction: Saliva is a promising biological fluid to be used for measuring a number of analytes. Aim of this ppaperis to verify if salivary anti-SARS-CoV-2 antibodies determination could be suitable for monitoring the viral spread andvaccination efficacy during the COVID-19 epidemic.Methods: a total of 69 subjects were enrolled at the Padova University Hospital: 39 COVID-19 patients and 30 health careworkers (HCW), who underwent a complete vaccination cycle with BNT162b2. All subjects collected a salivary sample,using Salivette, (SARSTEDT AG & Co, Nümbrecht, Germany). For 9 HCW, salivary samples were collected at threedifferent times within the same day. A serum sample was also obtained for all individuals. Salivary COVID-19 N/S1 RBD(sal-IgG) and serum anti-SARS-CoV-2 S-RBD IgG Ab (ser-IgG) were used for determining anti SARS-CoV-2 antibodies.Results: positive sal-IgG were found in 67/69 (97.1%) samples; in serum samples, the positivity for ser-IgG was foundin 68/69 (98.6%). The sal-IgG median levels differed from COVID-19 to vaccinated HCW, being 0,21 kAU/L in patientssamples and 0,8 kAU/L in vaccinated HCV samples (p =0.030). Median levels for ser-IgG in COVID-19 and patientsvaccinated HCW were 121 kBAU/L and 940 kBAU/L (p <0.001) respectively. A statistically significant correlation was foundbetween ser-IgG levels and time post-vaccination in HCW (rho =-0.6292, p <0.001). Sal-IgG levels were not influencedby the daytime of collection (rho =0.148, p=0.373). Passing-Bablok regressions showed that sal-IgG and ser-IgGcomparability was assessable only when ser-IgG values were divided by 1000, showing slope and intercept values of 0.016(95%CI: 0.016-0.078) and 0,221 (95%CI:-0.097 to 0.786), respectively.Conclusions: sal-IgG are detectable both in COVID-19 and in vaccinated individuals and the values are not influencedby the daytime of collection. As expected sal-IgG were much lower than ser-IgG.</p>
Biochimica Clinica ; 47(1) 041-045 Contributi Scientifici - Scientific Paper

La sfida del riconoscimento del professionista in Medicina di Laboratorio in Europa: gli strumenti a disposizione per aumentarne la visibilità e la qualità
The challenge of recognising Laboratory Medicine professionals in Europe: available tools to increase their expertise and visibility
P. Zaupa \| J. Turkman \| M. Zaninotto \| D. Basso \|
<p> </p><p> <span style="font-size:9.0pt">Laboratory Medicine is essential in all steps of patient care and to maintain and improve its value, promoting its recognition and visibility is vital, but such endeavor is hampered by a lack of harmonization across the European Union (EU). Specialists have different names, pre-graduate education, legal status and specialist training. Thanks to the European Directive 2013/55/EU, automatic recognition of a profession is possible if one third of EU nations agree on the adoption of a “Common Training Framework’’ (CTF), which defines the common set of knowledge, skills and competences needed to pursue a profession. The EFLM Syllabus was used as a base upon which to build the CTF regarding specialist training, along with EFLM’s Equivalence of Standards (EoS) for pre- and post-specialty requirements. Professionals who trained following the Syllabus and meet EFLM’s EoS can be added to the EFLM’s European Register of Specialists in Laboratory Medicine. Standardization of specialist training is required to improve the quality of our profession and will allow specialists to work in different countries more easily. This is further facilitated by the EFLMLabX platform. The adoption of the CTF, the continuous harmonization process, the EFLM’s Register and its available tools to improve specialists’ skills and competences will increase the visibility of our profession, facilitating its recognition process by the European Parliament. This undertaking is not only needed for the recognition of our profession, but to also improve its quality across all European countries, which will positively reflect on patient care.</span></p>
Biochimica Clinica ; 46(4) 342 Documenti - Documents

Approcci diagnostici innovativi per le malattie infiammatorie croniche intestinali
New diagnostic approaches for inflammatory bowel diseases
A. Padoan \| D. Basso \| N. Contran \| M. Plebani \| R. D'Incà \| G. Arrigoni \| ML. Scapellato \|
<p>Inflammatory bowel diseases (IBD), that include ulcerative colitis (UC) and Crohn’s disease (CD) are among the most serious and perplexing digestive diseases. Indeed, diagnosis is sometimes delayed due to the variability and subtlety of its initial manifestations, especially in CD. Since no gold standard is currently defined for the diagnosis and monitoring of IBD, a number of genomic, metabolomic and proteomic studies have tried to address this issue. After illustrating the traditional diagnostic approach (mainly fecal calprotectin), this Opinion Paper reports about the utility of some new biomarkers (micro-RNA, proteomic and metabolomic markers). In particular, the results of a study on fecal peptides are commented. After verifying that proteolytic degradation was clearly visible in fecal samples of a number of control (n=34) and patients with IBD (n=133), the matrix-assisted laser desorption ionization (MALDI) time of flight (TOF) mass spectrometry was used to evaluate peptides patterns of fecal samples, in a range from 1000 to 4000 Da. This cohort was used to derive an algorithm for IBD diagnosis. Diagnostic performances were then estimated using an additional validation cohort, including subjects with IBD (n=42) and without IBD (n= 28). Sensitivity was 54.8% (95%CI: 38.7%–70.2%) and specificity 96.4% (95%CI: 81.7%–99.9%) with a positive and a negative predictive value of 95.8% (95%CI: 76.7%–99.4%) and 58.7% (95%CI: 50.3–66.6%), respectively. In comparison, fecal calprotectin, achieved sensitivity and specificity of 78.6% (95%CI: 63.2%–89.7%) and 42.9% (95%CI: 24.5%–62.8%). In spite of the obtained good diagnostic performances, any candidate biomarker, once identified, should be carefully validated before being translated into clinical practice.</p>
Biochimica Clinica ; 45(1) 052-056 Opinioni - Opinions

I micro-RNA quali potenziali biomarcatori per la diagnosi e la prognosi del cancro del pancreas: scelte metodologiche e criticità
Micro-RNAs as potential diagnostic and prognostic biomarkers in pancreatic cancer: methodological choices and issues
A. Aita \| P. Plebani \| D. Basso \| C. Sperti \| L. Moletta \| C. De Pittà \| C. Millino \| B. Pacchioni \| S. Pedrazzoli \|
<p>Pancreatic cancer is the fourth cause of the death by cancer worldwide. It remains the only cancer whose survival has not improved in the last 40 years (only 18% of patients are still alive after 1 year, and 5% after 5 years), because of the high metastatic capacity and chemoresistance of the tumour. Complete tumour resection offers a chance to improve prognosis, but only 20% of patients are suitable for surgery. Although carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA 19-9) are commonly used biomarkers in clinical practice, they are not sufficiently sensitive and specific for early diagnosis neither for predicting response to treatment. The search for biomarkers for early diagnosis, post-operative surveillance and prognosis prediction is therefore fundamental in the context of pancreatic cancer.<br />Circulating micro-RNAs (miRNAs), emerging regulators of gene expression, have been reported by several studies as powerful non-invasive biomarkers in the pancreatic cancer setting, because of their presence and stability in human body fluids. Distinctive miRNAs expression profiles have been associated to pancreatic cancer; furthermore, changes in their expression seems to identify cancer development and response to treatment. Although many papers have been published in this field, the results are still controversial and no consensus has reached about sample type, methodologies and protocols to be adopted thus hampering their introduction into routine practice. This paper aims to summarize the methodological choices in the analysis of circulating miRNAs with particular focus on the critical points of the different phases of the process.</p>
Biochimica Clinica ; 45(1) 026-034 Rassegne - Reviews

Polimorfismi dei geni KLK3, RASA1 e NAALADL2: rischio di cancro alla prostata, aggressività della neoplasia e livelli sierici dell’Antigene Prostatico-Specifico
Polymorphisms of KLK3, RASA1 and NAALADL2 genes: prostate cancer risk, aggressiveness of neoplasia and serum PSA levels
D. Bozzato \| C.F. Zambon \| A. Padoan \| M. Pelloso \| A. Aita \| S. Moz \| F. Navaglia \| T.P. Galetti \| F. Zattoni \| D. Basso \| M. Plebani \|
<p>Background: prostate cancer (Pca) is the second most common cancer among men and the sixth leading cause of death due to cancer among men worldwide. We aimed to verify if serum PSA levels and PCa risk/aggressiveness are modulated by polymorphisms of KLK3, RASA1 and NAALADL2 genes.<br />Methods: 1058 men have been studied; they consecutively underwent prostate biopsy for clinical suspicion of PCa. PCa was histologically diagnosed in 401 and ruled out in 657 men. Gleason score in PCa patients was ≤6 in 261, 7 in 83 and >7 in the remaining 57 PCa. tPSA and f/tPSA levels were determined. Four polymorphisms were studied: rs35148638 (RASA1), rs78943174 (NAALADL2), rs2735839 and rs17632542 (KLK3).<br />Results: PCa diagnosis was significantly predicted by the KLK3 rs17632542 polymorphism (p<0.001), tPSA (p<0.001) and f/tPSA (p<0.001). Carriers of the KLK3 rs17632542C rare allele had a significantly higher risk of PCa (p<0.001) (OR 2.1, 95% CI 1.40-3.19). Gleason score >7 was associated with increased tPSA (p<0.001), decreased f/tPSA (p=0.003) and the KLK3 rs2735839 A rare allele (p= 0.004). In controls, tPSA was significantly lower in subjects bearing NAALADL2 rs78943174T rare allele (p=0.029). f/tPSA was higher in subjects with the KLK3 rs17632542C rare allele (p<0.001) and with the RASA1 rs35148638 C/C genotypes (p=0.009). In PCa subjects, tPSA was not associated with the polymorphisms studied.<br />Conclusions: KLK3 rs17632542 and rs2735839 polymorphisms were significantly associated with the risk and aggressiveness of PCa respectively. NAALADL2, KLK3 rs17632542 and RASA1 polymorphisms were correlated with tPSA and f/tPSA serum levels, suggesting a genetically-based PSA expected values in absence of tumor. These results suggest a potential role of these polymorphisms as biomarkers for PCa in association with the diagnostic and prognostic indexes currently recognized.</p>
Biochimica Clinica ; 44(4) 359-366 Contributi Scientifici - Sscientific Papers