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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357327
• Other study ID #: 68/2020
• Status: Completed
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• SARS-CoV 2
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	ASST dei Sette Laghi	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.