Background: The coronavirus disease 2019 (COVID-19) is an ongoing viral pandemic emergency. It has been reported up to 9% of reactivation in Covid-19 patients after discharge from hospital. Currently, diagnosis of Covid-19 infection is confirmed by RT-PCR technique for SARS-CoV-2 detection on nasopharyngeal (NP) swab with a sensitivity of approx 70%. False negative results may result from fluctuation of the presence of the virus in the biological samples. Therefore, novel diagnostic tools, able to identify the presence of the SARS-CoV-2 also in cases with transient viral shedding may significantly improve the management and the chance to control virus spreading.
Objective: primary objective is to evaluate the efficacy of contact lens (CL) application for 7 days to identify the presence of SARS-CoV-2 in convalescent patients, even in the presence of two consecutive negative NP swabs. Secondary objectives include: i. evaluation of sensitivity and specificity of nasal swab removed after 7 days to identify the presence of SARS-CoV-2 in convalescent patients; ii. sensitivity and specificity of SARS-CoV-2 detection on salivary and tears samples compared with standard NP swabs.
Methods: Fifty patients with diagnosis of Covid-19 hospitalized in the COVID-Center at Azienda Ospedaliero-Universitaria Policlinico Umberto I- Sapienza University, will be included in the study. All patients are waiting for NP swab to confirm Covid-19 recovery. Tear and nasal secretion will be collected during 7 days by CL and nasal swab application to evaluate sensitivity and specificity of these novel tools for the confirmation of SARS-Covid-2 recovery.
Expected results: The results of the project will demonstrate if simple, cheap and easy to use devices, such as CL and nasal swab, may improve diagnostic methods and avoiding false negative results. Moreover, the results of this study will pave the way to the use of these innovative diagnostic tools in other challenging infections.
Extrapulmonary involvement including central nervous system, eyes, nose and mouth in patients with COVID-19 has been clearly demonstrated, with detection of viral RNA in biological samples such as tears, and saliva. Infection of such extrapulmonary organs may serve as a reservoir for SARS-CoV-2, representing a potential source of viral shedding in both recovered patients or in asymptomatic individuals. It is extremely important to understand this phenomenon, as individuals with intermittent virus shedding could be falsely identified as recovered while they may benefit from ongoing antiviral treatment. Therefore, increasing understanding of the involvement of extrapulmonary organs may improve management of Covid-19 patients and control of pandemic spread. By this point of view, this project aims at developing novel tools to detect the presence of SARS-Covid-2 on human biological fluids, such as tears and/or nasal secretion even in the presence of transient viral shedding. Specifically, up to date, convalescent patients require two consecutive negative NP swabs for the presence of SARS-Cov-2 to confirm recovery of the infection. However, due to the limitations of current techniques and to the transient viral shedding which may escape the NP swab collection, some patients may result as double false negative. In this project, tear and nasal secretion will be collected during 7 days by CL and nasal swab application to evaluate sensitivity and specificity of these novel tools for the confirmation of SARS-Covid-2 recovery. These tolls are simple, cheap and easy to use and may improve management of patients with Covid-2 as well as reduce the contagion by ameliorating the diagnostic methods and avoiding false negative results.
Moreover, the results of this study will pave the way to the use of these innovative diagnostic tools in other challenging infections, such as Acanthamoeba or different members of Herpsesviridae family.