Project STARFISH - PRJ0002679 (STARFISH)

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection; Influenza A; RSV Infection; Influenza Type B
• Intervention / Treatment: Diagnostic test: The Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

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 Type: Observational
• Enrollment (Actual): 1909

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92111
      • Women's Health Care Research
  • Florida
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates
    • Miami, Florida, United States, 33155
      • D&H National Research Centers
  • Indiana
    • Fishers, Indiana, United States, 46037
      • Quantigen
  • Maryland
    • Columbia, Maryland, United States, 21045
      • KUR Research at Columbia Medical Practice
  • Michigan
    • Dearborn Heights, Michigan, United States, 48127
      • Vida Clinical Studies
  • Missouri
    • Kansas City, Missouri, United States, 64110
      • MRI Global
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Clinical Research Center of Nevada
  • New Jersey
    • Hillsdale, New Jersey, United States, 07642
      • KUR Research at AFC Urgent Care
    • Paramus, New Jersey, United States, 07652
      • KUR Research at AFC Urgent Care
  • North Carolina
    • Henderson, North Carolina, United States, 27537
      • Mako Medical Laboratories
    • Winston-Salem, North Carolina, United States, 27103
      • Progressive Medicine of the Triad
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Jackson, Tennessee, United States, 38305
      • Helios Clinical Research
  • Texas
    • Keller, Texas, United States, 76248
      • Helios Clinical Research
  • Utah
    • Riverton, Utah, United States, 84096
      • Granger Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SARS-CoV-2 infection; 50 positive samples 500 negative samples	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).
Influenza A infection; 50 positive samples 500 negative samples	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).
Influenza B infection; 30 positive samples 500 negative samples	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).
RSV infection; 30 positive samples 500 negative samples	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	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.	Between February 2023 and April 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	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.	Between February 2023 and April 2024

Collaborators and Investigators

• Sponsor: Thermo Fisher Scientific, Inc
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections; Pneumovirus Infections; COVID-19; Infections; Communicable Diseases; Influenza, Human; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: PCP0127284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No