Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid Test
Public ClinicalTrials.gov record NCT07190131. 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
Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This observational study aims to evaluate the diagnostic performance of an investigational Influenza A/B and COVID-19 test in patients presenting 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, and SARS-CoV-2 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
- NCT07190131
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 588 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years 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 11, 2024
- Primary completion
- Dec 11, 2025
- Completion
- Dec 11, 2025
- Last update posted
- Jan 7, 2026
2024 – 2025
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 13
| 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 008 | Los Angeles | California | 90057 | — |
| iHealth Site 013 | Doral | Florida | 33122 | — |
| iHealth Site 004 | Fort Lauderdale | Florida | 33308 | — |
| iHealth Site 005 | Fort Lauderdale | Florida | 33312 | — |
| iHealth Site 014 | Tamarac | Florida | 33321 | — |
| iHealth Site 009 | Ammon | Idaho | 83406 | — |
| iHealth Site 024 | Smithfield | Pennsylvania | 15478 | — |
| iHealth Site 020 | Chattanooga | Tennessee | 37412 | — |
| iHealth Site 003 | Brownsville | Texas | 78520 | — |
| iHealth Site 002 | Edinburg | Texas | 78539 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07190131, 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 7, 2026 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07190131 live on ClinicalTrials.gov.