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First received: January 26, 2023

Clinical Trial: Project STARFISH - PRJ0002679

Study Status: ACTIVE_NOT_RECRUITING

Recruit Status: ACTIVE_NOT_RECRUITING

Condition: SARS-CoV-2 Infection

Study Type: OBSERVATIONAL


Official Title: IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679

Brief Summary: This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor.In order to meet the minimum sample requirements, and to demonstrate performance on a range of viral strains, the prospective collection may be supplemented with banked remnant nasal and/or nasopharyngeal samples.

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