Trials / Completed
CompletedNCT05800158
Butterfly - Clinical Performance Study
Butterfly (IVD -TAQPATH V1 510K) - Clinical Performance Study Protocol - PRJ0003622
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,076 (actual)
- Sponsor
- Thermo Fisher Scientific, Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-04-12
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
- First posted
- 2023-04-05
- Last updated
- 2023-10-18
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05800158. Inclusion in this directory is not an endorsement.