Project STARFISH - PRJ0002679

Completed

• Conditions: SARS-CoV-2 Infection; Influenza A; RSV Infection; Influenza Type B

• Registration Number: NCT05727202
• Lead Sponsor: Thermo Fisher Scientific, Inc

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.

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.

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Study Start: 2023-02-20
• Status Verified: 2024-04
• Primary Completion: 2024-04-02
• Study Completion: 2024-04-02
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1909

Inclusion Criteria

• Participants of all ages must meet the following inclusion criteria to be eligible for participation in the study.

  • Ability to provide informed consent or assent (as age-appropriate). Stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection.
  • All-comers phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days.
  • Enrichment phase: Individuals suspected to have respiratory tract infection for seven (7) or fewer days, and with a standard of care positive PCR test result within three (3) days.

Exclusion Criteria

• Participants meeting the following criterion will be excluded from the study:

  • Suspected to have respiratory tract infection for greater than seven (7) days.
  • Patients not suspected of having a respiratory tract infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	Between February 2023 and April 2024	The primary endpoint of this clinical performance study is to meet the minimum sample positivity requirements for nasopharyngeal samples as defined by relevant regulatory guidance.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint	Between February 2023 and April 2024	The secondary endpoint of this study is to complete the clinical performance evaluation of the Starfish Test compared with that of a predicate device using Anterior nasal specimens and meet the minimum PPA and NPA requirements and acceptance criteria for each viral target as summarized in the protocol.

Trial Locations

Locations (15)

Women's Health Care Research; 🇺🇸 San Diego, California, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Multi-Specialty Research Associates; 🇺🇸 Lake City, Florida, United States

D&H National Research Centers; 🇺🇸 Miami, Florida, United States

Quantigen; 🇺🇸 Fishers, Indiana, United States

KUR Research at Columbia Medical Practice; 🇺🇸 Columbia, Maryland, United States

Vida Clinical Studies; 🇺🇸 Dearborn Heights, Michigan, United States

MRI Global; 🇺🇸 Kansas City, Missouri, United States

Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

KUR Research at AFC Urgent Care; 🇺🇸 Paramus, New Jersey, United States

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