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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 L. Pighi

Humoral response post-BNT162b2 single booster in pre-vaccination baseline SARS-CoV-2 seronegative and seropositive subjects

G.L. Salvagno \| BM. Henry \| L. Pighi \| S. De Nitto \| G. Gianfilippi \| G. Lippi \|
<p>Background: we report here data on humoral immune response post-BNT162b2 primary vaccination and booster in pre-vaccination baseline severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seronegative and seropositive subjects. Methods: the study population consisted in 51 baseline SARS-CoV-2 seronegative and 11 baseline SARS-CoV-2 seropositive subjects, who underwent primary mRNA-based BNT162b2 vaccination (two doses) followed by homologous booster administration (third dose). Venous blood was sequentially collected up to 1 months after vaccine booster administration, and humoral response was monitored by measuring anti-SARS-CoV-2 spike trimeric IgG antibodies. Results: the humoral response after the three doses of BNT162b2 displayed an overlapping trend in the two groups, although the baseline and post-primary vaccination concentration of anti-SARS-CoV-2 spike trimeric IgG were constantly higher in baseline SARS-CoV-2 seropositive than in baseline SARS-CoV-2 seronegative subjects (all p<0.001). Unlike before vaccine booster administration, the levels of anti-SARS-CoV-2 spike trimeric IgG, 1 month after receiving the third BNT162b2 dose were not significantly different between pre-vaccination baseline SARS-CoV-2 seropositive and seronegative subjects (7 430 versus 9 020 kBAU/L; p=0.232). In both cohorts, all recipients of vaccine booster displayed antibodies levels >264 kBAU/L. Conclusion: the results of this study demonstrate that although baseline SARS-CoV-2 seropositive subjects have magnified humoral response to primary BNT162b2 vaccination, vaccine booster generates anti-SARS-CoV-2 spike trimeric IgG values not different from those found in baseline SARS-CoV-2 seronegative subjects. Thus, this study provides evidence that a prior SARS-CoV-2 infection does not mitigate the need for additional vaccine boosters.</p>
Biochimica Clinica ; 46(3) 209-212 Contributi Scientifici - Scientific Papers

Longitudinal monitoring of anti-SARS-CoV-2 RBD IgG antibodies after BNT162b2 vaccination in healthcare workers

G. Salvagno \| BM. Henry \| L. Pighi \| S. De Nitto \| G. Gianfilippi \| G. Lippi \|

Biochimica Clinica ; 46(1) 083-085 Lettere all'Editore - Letters to the Editors

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

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 \| G. Barberio \| G. Barberio \| G.L. Salvagno \| M. Pepe \| 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 \| A. Coglianese \| V. D'Argenio \| E. Fiorio \| L. Crinò \| M. A. V. Willrich \| A. Modenese \| M. Berardi \| G. Nordera \| M. Girelli \| R. Tomaiuolo \| D. Giavarina \| R. Dittadi \| L. Pighi \| V. Guaraldo \| G. Bambagiotti \| E. Franceschini \| R. Danesi \| M. Locatelli \| F. Balboni \| D. Cosseddu \| M. Savoia \| S. Bernardini \| C. Domenichini \| M. Lamonaca \| M. Perrone \| M. Perrone \| per il Gruppo di Studio Intersocietario SIBioC-SIPMeL Diabete Mellito \| P. Pradella \| A. Padoan \| M.T. Sandri \| L. Belloni \| A. D'Avolio \| T. Trenti \| A. Fortunato \| T. Trenti \|

Biochimica Clinica ; 39(6) 546-547 Editoriale - Editorial