The Strategic Alliance between Clinical and Molecular Science in the War against SARS-CoV-2, with the Rapid-Diagnostics Test as an Indispensable Weapon for Front Line Doctors.

Antonio Vittorino Gaddi,Francesca Giampieri,Federico Culzoni,Leonardo Aluigi,Lucio Cosco,Michele Nichelatti,Maurizio Cipolla,Pier Luigi Antignani,Enrico Cipolla,Fabio Capello,Pasquale Ortasi,Maria Grazia Modena,Flavio Tangianu,Maria Teresa Savo,Francesco Dentali,Claudia Fragiacomo,Agostino Gnasso,Annapaola Callegaro,Gavino Casu,Tamara Y Forbes-Hernández ,Raffaele Mancini,Maurizio Battino,Angelo Paradiso ,Tommaso Diego Voci,María Eléxpuru Zabaleta ,S Martinelli Tempesta

doi:10.3390/ijms21124446

Abstract

Our work concerns the actual problem of spread of SARS- CoV-2 outbreak which requires fast and correct as possible answer. In current scenario, the need of rapid answer put away the imperative of proper methodology. We focus on the serogical immunoassay for diagnosis of Covid-19 as an important weapon not only for diagnostic purpose, but also for epidemiologic one. The right equilibrium between high speed, low cost and accuracy is obtained with easy-to-use decentralized point-of-care test as the colloidal gold-based immunochromatographic strip assay which detects IgM and IgG antibodies directed against SARS-CoV-2. As our aim is to evaluate the efficacy of Covid-19 rapid tests and of serological assays in real-life settings, we designed a research protocol aimed to establish how to use correctly these diagnostics, taking into account the different possible clinical and epidemiological scenarios.

Highlights

The COVID-19 pandemic is probably the most challenging health crisis of the modern era
Paramount— considering the clinical complexity of this new disease—to develop accurate, user-friendly kits, that can help doctors and healthcare workers to make a diagnosis of Covid-19
We investigated the quick detection approach targeting viral IgM or IgG antibodies, with the colloidal gold-based immunochromatographic (ICG) strip assay, in comparison with real-time real-time polymerase chain reaction (RT-PCR) testing

Summary

Introduction

The COVID-19 pandemic is probably the most challenging health crisis of the modern era. When properly collected and if the specimens collected for the analysis contains the virus, RT-PCR has high specificity and sensitivity. This technique has some limitations, such as the narrow number of patients that can be tested in a given time, the increased risk of exposure to a high-dose of virus for the healthcare workers collecting the sample (throat-swabbing can generate aerosol) and a considerable amount of time from the test to its response [4]. According to El-Tholoth et al [18], RT-PCR has some limitations for the screening and diagnosis of COVID-19, because the test is difficult to use in the community, and because of the high number of false-negatives observed

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Conclusion