SARS-CoV-2 Infection Clinical Trial
Official title:
IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
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.
The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (referred to below as "Starfish Test") aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria. This Clinical Performance Study Protocol (CPS Protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510(k) study requirements in the US. ;
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