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La Rivista Italiana della Medicina di Laboratorio 2020 Settembre;16(3):166-76

DOI: 10.23736/S1825-859X.20.00072-9


language: Italian

Diagnostic laboratory and COVID-19: is it possible to estabilish a strategy for the diagnosis of the SARS-CoV-2 infection through the combined use of molecular and serological tests?

Maria C. SORRENTINO , Giuseppina DI MARTINO, Daniele DI CARLO

Laboratorio di Patologia Clinica, Microbiologia e Virologia, Dipartimento dei Servizi Diagnostici e Terapeutici, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) IRCCS, Palermo, Italia

The SARS-CoV-2 (severe acute respiratory syndrome Coronavirus 2) pandemic, known as COVID-19, has involved the world’s population in an onerous and emotionally charged challenge with serious repercussions on health and economy, engaging medical personnel, health workers, scientists and politicians in the front line. SARS-CoV-2 first appeared in Wuhan, China, in December 2019 and is spreading worldwide. The epidemiology and ecology of the infection is not yet fully known: the virus reservoir has been identified in bats, but the intermediate host and the exact modalities of the species jump, with transmission to humans, are not yet unequivocally identified. In this scenario, laboratory medicine plays an important role, both in research and diagnostics. Today, we have more information on the nature of SARS-CoV-2: thanks to the research work of doctors, biologists and technicians in laboratories, we obtained more insights on gene sequence, pathogenetic mechanisms, the first therapeutic hypotheses and experiments for a vaccine. The identification of the sequences of the viral genome, consisting of a single stranded RNA, has led to the rapid availability of diagnostic tests based on the application of RT-PCR (reverse transcriptase - polymerase chain reaction), giving a fundamental tool for the early detection of viral RNA in rhino-pharyngeal swabs, the isolation and treatment of SARS-CoV-2 infections, the tracing of contacts and the promotion of social containment measures. However, the rapid geographical spread of the virus, with its high degree of contagiousness, the percentage of serious cases requiring hospitalization in intensive care units (ICUs) and the increased lethality found in some regions has caused great difficulty in the management of COVID-19 patients, due to the lack of adequate facilities and technologies. The finding of asymptomatic and/or paucisymptomatic subjects, with the virus in the incubation phase, has made even more evident the need for efficient and early diagnostics, but molecular tests, for various analytical and extra-analytical limitations, cannot be used as only diagnostic test in possible scenarios of virus spread, in the general population: a change of strategy is needed that is more adherent to daily clinical practice. We have seen rapid development of serological tests to identify the presence of anti-SARS-CoV-2 antibodies, but due to the lack of robustness of the available data, there is little evidence of their quality and diagnostic efficacy. The purpose of this discussion is to verify the possibility of a “real life” strategy in the management of SARS-CoV2 infection, through the integration of molecular and serological tests, to obtain indications on the best diagnostic algorithm to be applied, at the state of the art of recent knowledges.

KEY WORDS: Coronavirus; COVID-19; Diagnostic tests, routine; Serological tests; Antibodies

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