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

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).

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Key information

Conditions

COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST dei Sette Laghi

Varese, VA, 21100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

rapid salivary test

Diagnostic Test

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

Primary outcomes

Sensibility

Time frame: 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)
Specificity

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 22, 2020
Registry last updated: Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed