Project STARFISH - PRJ0002679
- Conditions
- SARS-CoV-2 InfectionInfluenza ARSV InfectionInfluenza Type B
- Interventions
- Diagnostic Test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1909
-
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.
-
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
- Arm && Interventions
Group Intervention Description SARS-CoV-2 infection The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel 50 positive samples 500 negative samples Influenza A infection The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel 50 positive samples 500 negative samples Influenza B infection The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel 30 positive samples 500 negative samples RSV infection The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel 30 positive samples 500 negative samples
- 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)
D&H National Research Centers
🇺🇸Miami, Florida, United States
Progressive Medicine of the Triad
🇺🇸Winston-Salem, North Carolina, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Women's Health Care Research
🇺🇸San Diego, California, United States
Mako Medical Laboratories
🇺🇸Henderson, North Carolina, United States
MRI Global
🇺🇸Kansas City, Missouri, United States
KUR Research at Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
Multi-Specialty Research Associates
🇺🇸Lake City, Florida, United States
KUR Research at AFC Urgent Care
🇺🇸Paramus, New Jersey, United States
Helios Clinical Research
🇺🇸Keller, Texas, United States
Granger Medical Clinic
🇺🇸Riverton, Utah, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Vida Clinical Studies
🇺🇸Dearborn Heights, Michigan, United States
Quantigen
🇺🇸Fishers, Indiana, United States