Clinical trial NCT05800158: Butterfly - Clinical Performance Study
Official title: Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Coronavirus Infections
Lead sponsor: Thermo Fisher Scientific, Inc
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 1076
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 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.

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.

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.
* 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

Primary outcomes:
measure: Clinical performance evaluation of the COVID-19 test
timeFrame: Between April 2023 and August 2023
measure: Identification of adverse events
timeFrame: Between April 2023 and August 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: KUR Research at Exer Urgent Care - Manhattan Beach
state: California
city: Redondo Beach
country: United States
facility: KUR Research at Exer Urgent Care - Redondo Beach
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: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Bronx
country: United States
facility: KUR Research at AFC Urgent Care
state: New York
city: Easley
country: United States
facility: KUR Research at AFC Urgent Care
state: South Carolina
city: Powdersville
country: United States
facility: KUR Research at AFC Urgent Care
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: McKinney
country: United States
facility: KUR Research at CityDoc Urgent Care
state: Texas
Study officials:
References: