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

Not Applicable

Completed

• Conditions: SARS-CoV 2; COVID-19; Corona Virus Infection
• Interventions: Diagnostic Test: rapid salivary test

• Registration Number: NCT04357327
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study Start: 2020-04-16
• Study First Submitted QC: 2020-04-18
• Study First Posted: 2020-04-22
• Primary Completion: 2020-05-31
• Study Completion: 2020-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asymptomatic subjects	rapid salivary test	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.
Symptomatic patients	rapid salivary test	Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.

Primary Outcome Measures

Name	Time	Method
Specificity	Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.	TN/TN+FP (TN= True Negative; FP= False Positive)
Sensibility	Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.	TP/TP+FN (TP= True Positive; FN = False Negative)

Trial Locations

Locations (1)

ASST dei Sette Laghi; 🇮🇹 Varese, VA, Italy