Covid Flu A/B and RSV 4 in 1 Diagnostic Test
Public ClinicalTrials.gov record NCT07308158. 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
Human Factors and Clinical Validation of the iHealth Labs Inc iHealth Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection. The main questions it aims to answer are: 1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, , SARS-CoV-2 and respiratory syncytial virus antigen. 2. What is the overall positive and negative percent agreement between the investigational test and the reference method? Participants will: 1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device. 2. Provide an additional specimen for testing with the FDA-cleared reference method.
Study identification
- NCT ID
- NCT07308158
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,119 participants
Conditions and interventions
Conditions
Interventions
- Investigational Flu A/B Covid-19 and RSV Diagnostic Test Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 6 Months and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 15, 2024 (Actual)
- Primary completion
- Dec 12, 2025 (Actual)
- Completion
- Dec 12, 2025 (Actual)
- Last update posted
- Jan 8, 2026
2024 – 2025
United States locations
- U.S. sites
- 21
- U.S. states
- 9
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| iHealth Site 006 | Birmingham | Alabama | 35242 | — |
| iHealth Site 021 | Trussville | Alabama | 35173 | — |
| iHealth Site 017 | Dublin | California | 94568 | — |
| iHealth Site 007 | Huntington Park | California | 90255 | — |
| iHealth Site 026 | Toluca Lake | California | 91602 | — |
| iHealth Site 011 | DeLand | Florida | 32720 | — |
| iHealth Site 013 | Doral | Florida | 33122 | — |
| iHealth Site 004 | Fort Lauderdale | Florida | 33308 | — |
| iHealth Site 005 | Fort Lauderdale | Florida | 33312 | — |
| iHealth Site 019 | Palm Springs | Florida | 33461 | — |
| iHealth Site 014 | Tamarac | Florida | 33321 | — |
| iHealth Site 009 | Ammon | Idaho | 83406 | — |
| iHealth Site 027 | Edison | New Jersey | 08820 | — |
| iHealth Site 015 | Simpsonville | South Carolina | 29681 | — |
| iHealth Site 016 | Spartanburg | South Carolina | 29301 | — |
| iHealth Site 020 | Chattanooga | Tennessee | 37412 | — |
| iHealth Site 003 | Brownsville | Texas | 78520 | — |
| iHealth Site 002 | Edinburg | Texas | 78539 | — |
| iHealth Site 018 | El Paso | Texas | 79902 | — |
| iHealth Site 023 | Mesquite | Texas | 75149 | — |
| iHealth Site 025 | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07308158, 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 Jan 8, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07308158 live on ClinicalTrials.gov.