Corona Virus Infection, COVID-19, SARS-CoV 2
Conditions
Keywords
SARS-CoV-2, COVID-19, Saliva, nCoV-2019, Coronavirus
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).
Interventions
DIAGNOSTIC_TESTrapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The rapid salivary test will provide results within 5-10 minutes, while the rRT-PCR performed on nasopharyngeal swab shows results only after 6 hours, thus the outcome assessor of the experimental test is blinded
Intervention model description
Consecutive recruitment of both patients with COVID-19 like symptoms (i.e., cough, fever, dyspnea) and patients with low risk phenotype
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Italy
Outcome results
None listed