FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Public ClinicalTrials.gov record NCT05928507. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05928507
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,500 participants
Conditions and interventions
Interventions
- Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2023
- Primary completion
- Feb 28, 2024
- Completion
- Mar 29, 2024
- Last update posted
- Jul 2, 2023
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wake Med | Raleigh | North Carolina | 27610 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05928507, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 2, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05928507 live on ClinicalTrials.gov.