Butterfly - Clinical Performance Study

Completed

• Conditions: Coronavirus Infections; COVID-19
• Interventions: Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

• Registration Number: NCT05800158
• Lead Sponsor: Thermo Fisher Scientific, Inc

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-05
• Study Start: 2023-04-12
• Primary Completion: 2023-08-10
• Study Completion: 2023-08-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1076

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2	Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit	Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider.

Primary Outcome Measures

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

Trial Locations

Locations (9)

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

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

ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States

KUR Research at Exer Urgent Care - Manhattan Beach; 🇺🇸 Manhattan Beach, California, United States

KUR Research at Exer Urgent Care - Redondo Beach; 🇺🇸 Redondo Beach, California, United States

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

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

KUR Research at CityDoc Urgent Care; 🇺🇸 McKinney, Texas, United States

KUR Research at AFC Urgent Care; 🇺🇸 Powdersville, South Carolina, United States