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Butterfly - Clinical Performance Study

NCT05800158 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1076

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Thermo Fisher Scientific, Inc

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2023-08-10
Completion
2023-08-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05800158 on ClinicalTrials.gov