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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

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


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

BC: Articoli scritti da G.L. Salvagno

Clinical assessment of FREND COVID-19 Ag test in an unselected population referred for routine SARS-CoV-2 testing
<p>Background: this observational retrospective study was aimed at evaluating the clinical performance of the novel microfluidic fluorescence immunoassay FREND COVID-19 Ag test in a population of unselected individuals undergoing routine SARS-CoV-2 (severe acute respiratory coronavirus 2) testing.<br />Methods: the study population consisted of a series of outpatients referred to the Service of Laboratory Medicine of Pederzoli Hospital (Peschiera del Garda, Verona, Italy) between April 12 and 30, 2021, for SARS-CoV-2 testing for being either symptomatic or having had close contact with one or more COVID-19 cases. A routine nasopharyngeal sample was collected at hospital admission and analyzed with both molecular (Altona Diagnostics RealStar&reg; SARS-CoV-2 RT-PCR Kit) and antigen (FREND COVID-19 Ag) tests.<br />Results: the area under the curve (AUC) of FREND COVID-19 Ag in all nasopharyngeal samples compared to molecular testing was 0.69 (95%CI, 0.64-0.75). At the &ge;1.0 TCID50/mL manufacturer&rsquo;s cut-off, accuracy, sensitivity, specificity, negative (NPV) and positive (PPV) predictive values were 61.3%, 0.27, 1.00, 0.55 and 1.00, respectively. The AUC of FREND COVID-19 Ag in samples with cycle threshold (Ct) values of both SARS-CoV-2 S and E genes &lt;29.5 was 1.00. At &ge;1.0 TCID50/mL (median tissue culture infective dose per mL) manufacturer&rsquo;s cut-off, accuracy, sensitivity, specificity, NPV and PPV values were 99.2%, 1.00, 0.99, 1.00 and 0.95, respectively.<br />Conclusions: FREND COVID-19 Ag could not replace routine molecular testing for achieving a definitive diagnosis of SARS-CoV-2 infection, but can be used as a surrogate test for identifying patients with higher nasopharyngeal viral load and thus greater infectious potential.</p>
Biochimica Clinica ; 45(4) 395-399
Contributi Scientifici - Scientific Papers
Guida sintetica alla diagnostica della malattia da coronavirus 2019 (COVID-19)
Concise guide to coronavirus disease 2019 (COVID-19) diagnostics
<p>Several months after its emergence, the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is still prepotently disrupting health, societies and economies worldwide. The current approach for diagnosing SARS-CoV-2 remains based on identification of viral RNA by means of molecular biology techniques in upper or lower respiratory tracts specimens. Nevertheless, the development of immune response against the virus may also provide valuable diagnostic information. The paradigmatic kinetics of anti-SARS-CoV-2 antibodies in patients with COVID-19 would allow to conclude that serological testing shall not replace viral RNA detection in diagnosing acute SARS-CoV-2 infection, but may instead remain an essential tool for identifying patients who have been infected and have developed an immune response, as well as for monitoring the progress of herd immunity. For this purpose, the choice of the antigens used for constructing the immunoassays appears critical, as these shall use epitopes towards which neutralizing antibodies could be generated. Other important aspects in serological testing encompass the absence of cross-reactivity with other coronaviruses, the ability to distinguish the antibody class (i.e. IgG, IgA and/or IgM), quantitative assessment, wide range of linearity and low imprecision at diagnostic thresholds. A finalaspect, almost essential for both clinical and public health purposes, is the evidence of analytical and clinical validation before each method enters clinical practice.</p>
Biochimica Clinica ; 44(4) 003-004
The role of acute phase proteins for predicting SARS-CoV-2 positivity upon emergency department admission
<p>Background: due to the important abnormalities observed in the concentration of many inflammation/infection biomarkers in patients with coronavirus disease 2019 (COVID-19), this study was aimed to evaluate whether the assessment of C-Reactive Protein (CRP), interleukin 6 (IL-6) and procalcitonin (PCT) could help predicting SARS-CoV-2 positivity at emergency department (ED) presentation in patients with suspected infection.<br />Methods: the study population consisted of patients consecutively admitted to the ED of the University Hospital of Verona, with clinical suspicion of SARS-CoV-2 infection over a 2-week period. Blood samples as well as oropharyngeal and nasopharyngeal swabs were collected upon ED admission.<br />Results: the final study population consisted of 92 patients, 48 with negative and 44 with positive SARS-CoV-2 swabs. No significant differences were observed in concentrations of CRP, IL-6, or PCT between patients with or without acute SARS-CoV-2 infection. A significant correlation was found between CRP and IL-6 in both negative (r=0.77) and positive (r=0.74) SARS-CoV-2 cases, between CRP and PCT in SARS-CoV-2 negative (r=0.38) and positive (r=0.44) cases, and between IL-6 and PCT in SARS-CoV-2 negative (r=0.37) and positive (r=0.40) cases. The area under the curve (AUC) of none of the biomarkers could efficiently discriminate patients with negative or positive swabs (CRP: 0.52; IL-6: 0.51; PCT: 0.53).<br />Conclusions: routine measurement of CRP and IL-6, together with PCT, does not seem a useful pre-test strategy in ED patients with clinical suspicion of COVID-19.</p>
Biochimica Clinica ; 44(4) 031-032
La Medicina di Laboratorio: gli specialisti di domani
Laboratory Medicine: specialists of tomorrow
<p>Laboratory Medicine rides the wave of technological progress, the metamorphosis of information systems and data management. The Young Specialist is not a mere observer, but rather takes a leading role in this change, taking advantage of the opportunities offered by &ldquo;omics&rdquo; technologies, capturing new ideas and innovative stimuli that lead to a new concept of work and research oriented to health and prevention. Thanks to the support of international web platforms, training and exchange programs supported by the International Scientific Societies and Federations that favor professional and scientific growth, Young Scientists work in a global context. In this scenario, the SIBioC Young Scientists Study Group, with the auspices of SIBioC, EFLM and IFCC, organized a meeting on &quot;Laboratory Medicine: Specialists of tomorrow&quot; with the aim of discussing and highlighting some of the most important challenges, such as technological progress, training and internationalization of young people. Finally, the future of laboratory medicine looks at a multidisciplinary approach that leads to integrated diagnosis, identification of the frail patient, the use of the Point of Care Testing as an indispensable tool in crisis areas, making the dialogue between physician and laboratory specialist a fundamental step for the diagnosis and treatment with the final aim of a better outcome for the patient.</p>
Biochimica Clinica ; 43(4) 424-434
Documenti - Documents
La diagnostica di laboratorio nella sindrome da apparente eccesso di mineralcorticoidi
The laboratory diagnosis of apparent mineralocorticoid excess (AME)
<p>The apparent mineralocorticoid excess(AME) is a rare genetic disorder caused by impaired activity of the enzyme 11&beta;-hydroxysteroid dehydrogenase type2 (11&beta;HSD2). This abnormality is associated with cortisol excess and abnormal activation of mineralocorticoidreceptor, which is usually only activated by aldosterone. More than 50 known mutations have been associated withAME; whilst some epigenetic modifications may also be involved. AME causes severe hypertension and is hencetraditionally diagnosed during the first years of life. Deficit of 11&beta;HSD2 also occur in other physiopathologicalconditions like pre-eclampsia, sodium-sensitive hypertension and kidney or hepatic impairment. The biochemicaldiagnosis is conventionally made by quantifying tetrahydroxylated metabolites of cortisol (THF and allo-THF) andcortisone (THE) expressed as THF+allo-THF/THE ratio and using home-made Gas Chromatography-MassSpectrometry methods. Nevertheless, some recent studies showed more accurate characterization of 11&beta;HSD2deficit by measuring the urinary free cortisol/cortisone ratio with Liquid Chromatography-Tandem Mass Spectrometry.A final consensus on the preferred method to diagnose AME has not been reached so far, and more studies areneeded for better defining sensitivity and specificity of these tests in some different physiopathological conditionsassociated with 11&beta;HSD2 impairment.</p>
Biochimica Clinica ; 43(3) 264-268
Rassegne - Reviews
Raccomandazioni per l’identificazione e la gestione dei risultati critici nei laboratori clinici
Recommendations for the detection and management of critical results in clinical laboratories
<p>Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient&rsquo;s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document.</p>
Biochimica Clinica ; 42(2) 167-179
Documenti SIBioC - SIBioC Documents
Verifica locale dei sistemi di prelievo nei laboratori clinici: adattamento delle linee guida EFLM
Blood collection systems in clinical laboratories: local adaptation of the EFLM guidelines
<p>The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies&rsquo; and laboratory&rsquo;s validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines.</p>
Biochimica Clinica ; 40(4) 347-352
Documenti SIBioC - SIBioC Documents
Armonizzazione in Medicina di Laboratorio
Harmonization in Laboratory Medicine
F. Ceriotti  |  M. Panteghini  |  A. Tosetto  |  V. Valentini  |  L. Politi  |  R. Rolla  |  T. Guastafierro  |  T. Köken  |  E. Capoluongo  |  C. Mazzaccara  |  V. D'Argenio  |  V. D'Argenio  |  G. Lippi  |  M. Plebani  |  D. Giavarina  |  M. Berardi  |   A survey on sample matrix and preanalytical management in clinical laboratories  |  D. Bozzato  |  G. Messeri  |  M. Zaninotto  |  M. Vidali  |  A. Padoan  |  G. Parigi  |  A. Clerico  |  L. Sciacovelli  |  M. Ciaccio  |  G.L. Salvagno  |  M. Panteghini  |  F. Braga  |  G. Gessoni  |  M. Montagnana  |  N. Doğan  |  M. Barberis  |  M. Barberis  |  A. Marchetti  |  F. Borrillo  |  L. Bonfanti  |  P.M. Ness  |  G. Messeri  |  S. Nannini  |  J. Queraltò  |  M. Zaninotto  |  A. Mosca  |  BM. Henry  |  G. Santini  |  E. Fiorio  |  L. Crinò  |  M. A. V. Willrich  |  A. Modenese  |  M. Berardi  |  G. Nordera  |  M. Girelli  |  R. Tomaiuolo  |  D. Giavarina  |  R. Dittadi  |  L. Pighi  |  R. Danesi  |  M. Locatelli  |  F. Balboni  |  D. Cosseddu  |  M. Savoia  |  S. Bernardini  |  C. Domenichini  |  M. Lamonaca  |  M. Perrone  |  M. Perrone  |  P. Pradella  |  A. Padoan  |  L. Belloni  |  A. D'Avolio  |  T. Trenti  |  A. Fortunato  |  T. Trenti  | 
Biochimica Clinica ; 39(6) 546-547
Editoriale - Editorial
Determinazione dell’ormone anti-mulleriano per la valutazione della riserva ovarica in pazienti dopo trattamento chemioterapico
Utility of anti-mullerian hormone for the evaluation of fertility preservation in female patients after chemotherapy
<p>The new advances in the treatment have greatly increased the life expectancy of premenopausal women with&nbsp;hematological malignancies. The susceptibility of their ovarian reserve to chemotherapy is however highly variable. The&nbsp;anti-mullerian hormone (AMH) is one of the most sensitive markers of ovarian reserve and fertility preservation. In this study,&nbsp;antral follicle counts (AFC), serum AMH, follicle stimulating hormone (FSH) and inhibin B were assayed in female patients&nbsp;treated for lymphoma and hematological disease to characterize the evolution of fertility preservation. 63 consecutive&nbsp;women (48 with Hodgkin&#39;s lymphoma, 9 non-Hodgkin&#39;s lymphoma, 6 acute myeloid leukemia) were eligible for enrolment.&nbsp;All patients [median age, 31 years (range: 17-40)] were in complete remission with a median follow-up time of 9.0 years&nbsp;after therapy. 64 healthy controls were also evaluated [median age, 31 years (range: 20-42)]. Participants had a baseline&nbsp;blood drawing during the early follicular phase of the menstrual cycle. A significant difference in AFC (9.8 vs. 16.0,&nbsp;P=0.0001), AMH (2.02 &mu;g/L vs. 2.97 &mu;g/L, P=0.02), FSH (16.9 U/L vs. 8.1 U/L, P=0.03) and inhibin B (33.7 ng/L vs. 69.4&nbsp;ng/L, P &lt;0.005) was observed between patients and controls. The ROC curve analysis comparing AMH and FSH&nbsp;concentrations of patients (at the same AFC cut-off point of 8) revealed that AMH had a better area under the curve (0.904)&nbsp;than FSH (0.678) (P=0.0013). The ovarian reserve is reduced in female patients affected by hematological malignancies&nbsp;after chemotheraphy. AMH is the most reliable serum marker of fertility preservation in these subjects.</p>
Biochimica Clinica ; 38(5) 374-377
Contributi scientifici - Scientific Papers
Proposta di una “checklist” per il prelievo di sangue venoso
Proposal of a checklist for venous blood collection
<p>The collection of venous blood is central in clinical laboratory&nbsp;activity. Although there is widespread perception that this practice is simple and free of complications and side effects,&nbsp;it is undeniable that the vast majority of laboratory errors arises from ignorance, incompetence or negligence during&nbsp;venipuncture. It has hence become advisable to prepare a document in simplified form of checklist, consisting of a&nbsp;concise but comprehensive list of activities to be completed or verified in order to prevent errors during venous blood&nbsp;collection. In the intention of authors, this synthetic checklist is a modular tool, adaptable to different local contexts,&nbsp;it can be easily and gradually implemented, it is supported by scientific evidence and consensus of experts and&nbsp;created with the support of different healthcare professionals and it is adherent to the best practices and requires&nbsp;minimal resources for implementation. It is reasonable to assume that this checklist may be able to withstand system&nbsp;and individual changes, strengthening the standards for safety of both operators and patients, limiting potential failure&nbsp;patterns. We hope that the checklist may be implemented in all healthcare facilities where routine venous blood&nbsp;collection is performed, after adaptation to suit characteristics of local organization.</p>
Biochimica Clinica ; 37(4) 312-317
Documenti SIBioC - SIBioC Documents
Raccomandazioni di consenso SIBioC-SIMeL per la rilevazione e gestione dei campioni emolisati e utilizzo dell'indice di emolisi
SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens and the implementation of hemolysis index
<p><strong>SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens</strong><br /><strong>and the implementation of hemolysis index.</strong> The presence of hemolysis in a biological blood sample is mainly<br />caused by hemolytic anemia or hemolysis in vitro. The latter is caused by inappropriate collection and processing of biological samples, which may affect the reliability of test results. Hemolysis is assessed by free hemoglobin quantification, whose limit is 0.02 g/L in plasma and 0.05 g/L in serum, and visually observed when the concentration of free hemoglobin exceeds 0.30 g/L. Since hemolysis is the most frequent cause of unsuitable biological samples in clinical laboratories, with a prevalence approaching 3% of all received samples, these recommendations have been drafted specifically to assist laboratory professionals in detection and management of hemolysed specimens. In summary, the recommended approach is based on: (i) systematic detection and quantification of hemolysis, by visual inspection and subsequent quantification of the hemolysis index on all samples with visually detectable hemolysis; (ii) immediate notification to the referring department of the presence of hemolysis in the sample, as locally determined; (iii) suppression of all results affected by the presence and/or degree of hemolysis; and (iv) timely request of a second sample, on which the previously deleted tests can be performed.</p>
Biochimica Clinica ; 35(6) 481-490
Valutazione del "risk of ovarian malignancy algorithm" (ROMA) nella stima del rischio di tumore epiteliale maligno dell'ovaio in donne con massa pelvica
The "risk of ovarian malignancy algorithm" for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass.
Biochimica Clinica ; 35(1) 30
Longitudinal monitoring of anti-SARS-CoV-2 RBD IgG antibodies after BNT162b2 vaccination in healthcare workers
Biochimica Clinica ; 17(1) 10.19186/B
Lettere all'Editore - Letters to the Editors