Butterfly - Clinical Performance Study

Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622

This prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the COVID-19 test using upper respiratory specimens. Prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections; COVID-19
• Intervention / Treatment: Diagnostic test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

Detailed Description

The Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit (referred to as "COVID-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.

The purpose of this study is to evaluate the clinical performance of the TaqPath™ COVID-19 Diagnostic PCR Kit (COVID-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of COVID-19 by their health care provider.

A composite comparator approach will be used to evaluate the performance of the COVID-19 test which includes the use of three highly sensitive SARS-CoV-2 molecular assays as comparators. Clinical calls will be compared between COVID-19 test and the three composite comparators. The third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. The 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): 1076

Contacts and Locations

• Study Contact: Name: Brittney Lehmann; Phone Number: 18582264583; Email: brittney.lehmann@thermofisher.com
• Study Contact Backup: Name: Sherrie Smartt; Phone Number: 15402477483; Email: sherrie.smartt@thermofisher.com

Study Locations

• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • KUR Research at Exer Urgent Care - Manhattan Beach
    • Redondo Beach, California, United States, 90277
      • KUR Research at Exer Urgent Care - Redondo Beach
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research
  • Florida
    • Lake City, Florida, United States, 32055
      • Multi Specialty Research Associates
    • Miami, Florida, United States, 33155
      • D&H National Research Centers
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Clinical Research Center Of Nevada
  • New York
    • Bronx, New York, United States, 10465
      • KUR Research at AFC Urgent Care
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • KUR Research at AFC Urgent Care
    • Powdersville, South Carolina, United States, 29611
      • KUR Research at AFC Urgent Care
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
  • Texas
    • McKinney, Texas, United States, 75204
      • KUR Research at CityDoc Urgent Care

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 COVID-19. 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.

• Individuals with at least one of the following COVID-19 symptoms:

  1. fever or chills
  2. congestion or runny nose
  3. headache or fatigue
  4. muscle or body aches

  b. new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea.

• Subjects suspected of having COVID-19 symptoms for seven (7) or fewer days.

Exclusion Criteria:

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

• Subjects suspected of having COVID-19 symptoms for greater than seven (7) days.
• Subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SARS-CoV-2; Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider.	Diagnostic test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit; A reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance evaluation of the COVID-19 test	Clinical performance evaluation of the COVID-19 test using a composite comparator approach with upper respiratory specimens to meet PPA and NPA requirements.	Between April 2023 and August 2023
Identification of adverse events	Identify any adverse events or complications associated with the COVID-19 test	Between April 2023 and August 2023

Collaborators and Investigators

• Sponsor: Thermo Fisher Scientific, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: PCP0131832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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