Name (Synonyms) | Correlation | |
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drug2355 | RTB101 Wiki | 1.00 |
drug2122 | Placebo Wiki | 0.05 |
Name (Synonyms) | Correlation | |
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D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
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).
Description: TP/TP+FN (TP= True Positive; FN = False Negative)
Measure: Sensibility Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.Description: TN/TN+FP (TN= True Negative; FP= False Positive)
Measure: Specificity Time: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.