NCT05727202

Project STARFISH - PRJ0002679

IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,909 (actual)
• Sponsor: Thermo Fisher Scientific, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• SARS-CoV-2 Infection
• Influenza A
• Influenza Type B
• RSV Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel	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).

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2023-02-14
• Last updated: 2024-04-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study