NCT07190131

Evaluation of COVID-19 and Flu A/B 3 in 1 Combo Rapid Test

Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 588 (actual)
• Sponsor: iHealth Labs inc · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COVID - 19
• Influenza A
• Influenza B

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Investigational Flu A/B And Covid-19 Diagnostic Test	A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B and SARS-CoV-2 from anterior nasal swab specimens.

Timeline

• Start date: 2024-11-12
• Primary completion: 2025-12-12
• Completion: 2025-12-12
• First posted: 2025-09-24
• Last updated: 2026-01-08

Locations

15 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study