Clinical trial NCT05727202: Project STARFISH - PRJ0002679
Official title: IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Influenza A
Influenza Type B
RSV Infection
Lead sponsor: Thermo Fisher Scientific, Inc
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-02-14
Enrollment: 1909
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be composed of participants suspected of respiratory tract infection from SARS-COV-2, Influenza A/B, or RSV. After a subject is determined eligible for study participation (met inclusion criteria and did not meet exclusion criteria) and has completed the institutional review board (IRB)-approved informed consent form process (or assent, as age appropriate), the subject is enrolled into the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: Between February 2023 and April 2024
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: Between February 2023 and April 2024
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Women's Health Care Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Lake City
country: United States
facility: Multi-Specialty Research Associates
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Fishers
country: United States
facility: Quantigen
state: Indiana
city: Columbia
country: United States
facility: KUR Research at Columbia Medical Practice
state: Maryland
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Kansas City
country: United States
facility: MRI Global
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Hillsdale
country: United States
facility: KUR Research at AFC Urgent Care
state: New Jersey
city: Paramus
country: United States
facility: KUR Research at AFC Urgent Care
state: New Jersey
city: Henderson
country: United States
facility: Mako Medical Laboratories
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad
state: North Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Jackson
country: United States
facility: Helios Clinical Research
state: Tennessee
city: Keller
country: United States
facility: Helios Clinical Research
state: Texas
city: Riverton
country: United States
facility: Granger Medical Clinic
state: Utah
Study officials:
References: