Butterfly - Clinical Performance Study

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800158
• Other study ID #: PCP0131832
• Status: Completed
• Start date: April 12, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: October 2023
• Source: Thermo Fisher Scientific, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1076
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

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.

Locations

Country	Name	City	State
United States	KUR Research at AFC Urgent Care	Bronx	New York
United States	ClinSearch	Chattanooga	Tennessee
United States	KUR Research at AFC Urgent Care	Easley	South Carolina
United States	Multi Specialty Research Associates	Lake City	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	KUR Research at Exer Urgent Care - Manhattan Beach	Manhattan Beach	California
United States	KUR Research at CityDoc Urgent Care	McKinney	Texas
United States	D&H National Research Centers	Miami	Florida
United States	KUR Research at AFC Urgent Care	Powdersville	South Carolina
United States	KUR Research at Exer Urgent Care - Redondo Beach	Redondo Beach	California
United States	Medical Center for Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Thermo Fisher Scientific, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Identification of adverse events	Identify any adverse events or complications associated with the COVID-19 test	Between April 2023 and August 2023