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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. Negrini

Carbamazepine and Carbamazepine-10,11-epoxide measurement with the reference LC-MS/MS method and a routine immunoassay
Carbamazepine and Carbamazepine-10,11-epoxide measurement with the reference LC-MS/MS method and a routine immunoassay
D. Negrini \| W. Magon \| D. Peserico \| G. Lippi \| E. Danese \|
<p>Introduction: Carbamazepine is a common antiepileptic drug used for treatment of epilepsy and other neurologic conditions. Carbamazepine-10,11-epoxide, one of its metabolites, is pharmacologically active and its values increase with concomitant use of other anticonvulsants. This study is aimed to compare the method used in our routine laboratory with a reference LC-MS/MS method for monitoring Carbamazepine, and to compare the concentrations of the drug to one of its metabolites. Methods: plasma samples were collected from patients for whom Carbamazepine measurement had been requested. For each plasma sample, Carbamazepine was assayed on Roche Cobas with Cobas CARB4 kit (immunoassay). Carbamazepine and Carbamazepine-10,11-epoxide determination were then performed with a validated and verified LC-MS/MS technique. Results: the study population consisted of 30 subjects. No significant differences were found between the routine immunoassay and the LC-MS/MS technique using Passing-Bablok regression and Bland-Altman graph, whilst the concentrations of plasma Carbamazepine and its epoxide measured with LC-MS/MS displayed a very modest correlation (r=0.639). The ratio calculated between Carbamazepine and its epoxide displayed a broad range of values (3.37-12.55). Discussion: considering the clinical significance of Carbamazepine measurement as part of TDM, we confirmed the validity of our routinely used immunoassay as easier and faster alternative to the reference method for routine quantification of plasma Carbamazepine concentration. Considering that levels of the epoxide are unpredictable and independent from the parent drug concentrations, a more comprehensive assessment of Carbamazepine metabolites should be considered, especially when patients have uncontrolled symptoms or display challenging dose adjustment.</p>
Biochimica Clinica ; 46(2) 117-121 Contributi Scientifici - Scientific Papers

Clinical assessment of FREND COVID-19 Ag test in an unselected population referred for routine SARS-CoV-2 testing

G. Salvagno \| G. Gianfilippi \| D. Negrini \| L. Pighi \| S. De Nitto \| BM. Henry \| G. Lippi \|
<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® 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 ≥1.0 TCID50/mL manufacturer’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 <29.5 was 1.00. At ≥1.0 TCID50/mL (median tissue culture infective dose per mL) manufacturer’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

La diagnostica di laboratorio nella sindrome da apparente eccesso di mineralcorticoidi
The laboratory diagnosis of apparent mineralocorticoid excess (AME)
E. Danese \| D. Negrini \| G.L. Salvagno \| C. Zaltron \| O. Olivieri \| G. Lippi \| F. Pizzolo \|
<p>The apparent mineralocorticoid excess(AME) is a rare genetic disorder caused by impaired activity of the enzyme 11β-hydroxysteroid dehydrogenase type2 (11βHSD2). 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 11βHSD2 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 11βHSD2deficit 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 11βHSD2 impairment.</p>
Biochimica Clinica ; 43(3) 264-268 Rassegne - Reviews