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

Study Overview
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Brief Summary
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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).

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

Conditions
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COVID-19, SARS-CoV 2, Corona Virus Infection

Intervention / Treatment
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* Diagnostic Test: rapid salivary test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consecutive recruitment of both patients with COVID-19 like symptoms (i.e., cough, fever, dyspnea) and patients with low risk phenotype
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic patients<br>Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc. | Diagnostic Test: rapid salivary test<br>* a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay<br>|
| Active Comparator: Asymptomatic subjects<br>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. | Diagnostic Test: rapid salivary test<br>* a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, Saliva, nCoV-2019, Coronavirus