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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
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Ana-Maria Simundic Croatia
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Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

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Chiara Riva
Biomedia srl
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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da T. Pirotti

Applicazione dell’analisi dei Big Data nella valutazione dell’utilità clinica della determinazione degli anticorpi anti SARS-CoV-2 di tipo IgM: l’esperienza di Modena
Big Data analysis to evaluate the clinical utility of IgM anti SARS-CoV-2 determination: the Modena experience
<p>Introduction: since the scarce diagnostic accuracy of specific circulating antibodies for SARS-CoV-2, we aimed to assess the clinical utility of IgM detection in SARS-CoV-2 using the Big Data analysis. Methods: this is a retrospective study; all the blood samples collected between March and September 2020 were processed using a lateral flow immunoassay (LFIA) kit for IgG and IgM antybody testing. Positives results were tested again using a chemiluminescent method. Subjects confirmed with a positive result were contacted for a molecular test.<br />Results: more than 69 000 serological tests (from 42 911 subjects) were performed. 94.5% (40 559/42 911) of subjects had negative results for both IgG and IgM. 1.5% (n = 640) subjects had both IgG and IgM positive results, and viral RNA research confirmed positivity in 16% (85/533). Among subjects with IgG negative and IgM positive results (n=271), a positivity was confirmed in 1% (4/270). Conversely, in subjects with IgG positive and IgM negative results, a positivity was confirmed in 8% (97/1 215). Therefore, the analysis suggests that up to 98% of serological test results of IgM positivity and IgG negativity are false positive.<br />Discussion: the study, based on Big Data analysis application, proved the scarce clinical utility of IgM detection in COVID-19 management, and underlines the responsibility of laboratory professionals in highlighting the limitations of the serological tests also due to uncertainty in their interpretation.</p><p>&nbsp;</p>
Biochimica Clinica ; 46(2) 154-159
Contributi Scientifici - Scientific Papers