COVID-19 Infection Clinical Trial
Official title:
Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
PRIMARY OBJECTIVE: I. To evaluate the clinical performance of a novel point-of-care diagnostic test for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the disease called coronavirus disease 19 (COVID-19). SECONDARY OBJECTIVES: I. To compare the clinical performance of provider-collected nasopharyngeal samples with self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2 diagnostic test. II. To measure viral load and evaluate the role of viral load in COVID-19 severity. OUTLINE: Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples. After completion of study, participants are followed up at 1 month. ;
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