NCT04357327

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

Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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).

Conditions

• COVID-19
• SARS-CoV 2
• Corona Virus Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	rapid salivary test	a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay

Timeline

• Start date: 2020-04-16
• Primary completion: 2020-05-31
• Completion: 2020-07-31
• First posted: 2020-04-22
• Last updated: 2020-11-04

Locations

1 site across 1 country: Italy