Serological determinants of COVID-19

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RESEARCH

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Serological determinants of COVID-19 Annalisa Noce1* , Maria Luisa Santoro2, Giulia Marrone1,3, Cartesio D’Agostini4,5, Ivano Amelio4,6, Andrea Duggento7, Manfredi Tesauro1* and Nicola Di Daniele1

Abstract Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests for determination of IgM and IgG antibodies has become the main diagnostic tool, useful for tracking the spread of the virus and for consequently allowing its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility for COVID-19 antibodies detection. Results: We find that different specificities and sensitivities for IgM and IgG tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while IgG POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide equivalent information. Conclusions: FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”. Keywords: SARS-CoV-2, COVID-19, Point of care, Lateral flow immunoassay, Automated chemiluminescent immunoassay, Serological tests, Laboratory detection

Background Coronavirus disease 2019 (COVID-19) is a novel coronavirus pneumonia caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1, 2]. Emergence of new infectious diseases poses serious clinical issues [3–9], this new infection was first encountered in December 2019 in Wuhan, Hubei Province, China, and then spread worldwide taking on the appearance of health emergency of international concern. Starting from February 2020, the COVID-19 outbreak spread in Europe, particularly affecting northern Italy and Spain [10–12]. World Health Organization (WHO), on 11th March 2020 declared COVID-19 disease a global world pandemic.

* Correspondence: [email protected]; [email protected] 1 UOC of Internal Medicine-Center of Hypertension and Nephrology Unit, Department of Systems Medicine, University of Rome Tor Vergata, via Montpellier 1, 00133 Rome, Italy Full list of author information is available at the end of the article

SARS-COV-2 belongs to the beta coronavirus family along with other human pathogens known as SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-Cov) [13]. As COVID-19 was identified as a health emergency by WHO, large-scale population testing proved to be of crucially important to identify and isolate symptomatic and asymptomatic case, in the global efforts to contain its expansion. In December 2019, SARS-COV-2 was firstly transmitted to humans through human-animal contact at live animals market in Wuhan (China) [14]. SARS-CoV-2 belongs to the subfamily of the Coronavirinae,