Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)

Università degli Studi dell'Insubria

Status: Completed

Conditions: COVID-19; SARS-CoV 2; Corona Virus Infection

Treatments: Diagnostic Test: rapid salivary test

Study type: Interventional

Funder types: Other

Identifiers

NCT04357327

68/2020

Details and patient eligibility

About

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).

Enrollment: 122 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

none

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Symptomatic patients

Experimental group

Description:

Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.

Treatment:

Diagnostic Test: rapid salivary test

Asymptomatic subjects

Active Comparator group

Description:

Asymptomatic patients with low risk phenotype, that means patients with a previous negative swab, no relatives affected by COVID-19 and with reduced social interaction within the last two weeks.

Treatment:

Diagnostic Test: rapid salivary test