Butterfly - Clinical Performance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-08-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19 Coronavirus Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2

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

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

Intervention Type DIAGNOSTIC_TEST

A reverse transcription, real-time polymerase chain reaction (RT-qPCR) test for the qualitative detection of SARS-CoV-2.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No