Butterfly - Clinical Performance Study

Thermo Fisher Scientific

Status: Completed

Conditions: COVID-19; Coronavirus Infections

Treatments: Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT05800158

PCP0131832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,076 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,076 participants in 1 patient group

SARS-CoV-2

Description:

Nasopharyngeal and anterior nasal swabs collected from symptomatic individuals suspected of COVID-19 by their health care provider.

Treatment:

Diagnostic Test: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit