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La Rivista Italiana della Medicina di Laboratorio 2020 Marzo;16(1):7-17

DOI: 10.23736/S1825-859X.20.00054-7

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: Italian

An overview on advantages and limitations of serological assays for SARS-CoV-2 infectious disease

Maria INFANTINO ¹ ✉, Arianna DAMIANI ², Francesca LI GOBBI ³, Valentina GROSSI ¹, Barbara LARI ¹, Donatella MACCHIA ⁴, Patrizia CASPRINI ⁵, Francesca VENEZIANI ⁶, Danilo VILLALTA ⁷, Nicola BIZZARO ⁸, Piero CAPPELLETTI ⁹, Martina FABRIS ¹⁰, Luca QUARTUCCIO ¹¹, Maurizio BENUCCI ³, Mariangela MANFREDI ¹

¹ Laboratorio di Immunologia e Allergologia, Ospedale S. Giovanni di Dio, Firenze, Italia; ² Reumatologia, Dipartimento di Medicina Sperimentale e Clinica, Università di Firenze, Firenze, Italia; ³ Reumatologia, Ospedale S. Giovanni di Dio, Firenze, Italia; ⁴ Allergologia e Immunologia Clinica, Ospedale S. Giovanni di Dio, Firenze, Italia; ⁵ Laboratorio di Patologia Clinica e Immunoallergologia, Firenze-Prato, Italia; ⁶ Laboratorio di Patologia Clinica, Ospedale S. Giovanni di Dio, Firenze, Italia; ⁷ Allergologia e Immunologia Clinica, Ospedale S. Maria degli Angeli, Pordenone, Italia; ⁸ Laboratorio di Patologia Clinica, Ospedale Sant’Antonio, Azienda Sanitaria Universitaria Integrata di Udine, Tolmezzo, Udine, Italia; ⁹ SIPMeL, Castelfranco Veneto, Treviso, Italia; ¹⁰ Istituto di Patologia Clinica, Università di Udine, Udine, Italia; ¹¹ Clinica Reumatologica, Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Dipartimento di Medicina (DAME), Università di Udine, Udine, Italia

COVID-19 infection (SARS-CoV-2) is a viral disease first encountered in Wuhan, China, in December 2019, then rapidly spreading around the world. During this current public health emergency of international concern, screening and diagnosing patients quickly in order to aid containment is a priority. Most of our knowledge on diagnostics comes from previous studies on SARS-CoV. Since SARS-CoV-2 belongs to the same large family of viruses as those that cause the MERS and SARS outbreak, we could assume that its antibody generation process should be similar. The high contagiousness and the characteristics of high lethality of the epidemic require efficient diagnostics, able to quickly identify the sources of the infection. The identification of patients with active SARS-CoV-2 infection is currently based on the amplification of a viral genome sequence using molecular biology techniques (real-time polymerase chain reaction), which can be subsequently confirmed by gene sequencing. However, the variability linked to the execution of the swab and the limitations of the test (complexity, biosecurity levels, costs and long response times) makes molecular diagnostics unsuitable for use in the field. Consequently, new tools such as serological tests capable of tracking the virus through each phase of the disease are in great demand. Serological antibody tests are already being developed and have already been introduced to the market. To date, however, there is no robust scientific evidence on the clinical-diagnostic reliability of these tests which therefore, at the moment, cannot replace the molecular test. The few studies in the literature are of limited thickness, sometimes discordant with each other and conducted on a small scale mainly on the Chinese population. In the absence of specific references, there is an open debate on the best use of these serological tests and on the ideal moment of their execution. In this review we describe the main characteristics of the SARS-CoV-2 virus, the diagnostic molecular strategies available today, and the first experimental data on the determination of antibodies directed towards SARS-CoV-2.

KEY WORDS: COVID-19; COVID-19 diagnostic testing; SARS virus; Coronavirus