The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program.

The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.

The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.

Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.

The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).

Inclusion Criteria:

People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection

Exclusion Criteria:

none

We could provide anamnestic, clinical and serological data of each participant at the end of the study, or at least at the end of the first phase.

Data will be available at the end of the study, once statistical analyses is conducted

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The rapid salivary test will provide results within 5-10 minutes, while the rRT-PCR performed on nasopharyngeal swab shows results only after 6 hours, thus the outcome assessor of the experimental test is blinded