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

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.

NCT Number	NCT07190131
Lead Sponsor	iHealth Labs inc
Conditions	COVID - 19, Influenza A, Influenza B
Enrollment	588 participants
Start Date	2024-11-12
Primary Completion	2025-12-12 (estimated)
Study Completion	2025-12-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-08