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CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness. The main question it aims to answer are: • the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Wake Med
Raleigh, North Carolina, United States
Start Date
October 2, 2023
Primary Completion Date
February 29, 2024
Completion Date
March 30, 2024
Last Updated
July 3, 2023
2,500
ESTIMATED participants
Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
DIAGNOSTIC_TEST
Lead Sponsor
Baebies, Inc.
NCT05421208
NCT07128615
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05667597