Covid Flu A/B and RSV 4 in 1 Diagnostic Test

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.

NCT Number	NCT07308158
Lead Sponsor	iHealth Labs inc
Conditions	Influenza A, Influenza B, COVID - 19, RSV
Enrollment	1,119 participants
Start Date	2024-11-15
Primary Completion	2025-12-12 (estimated)
Study Completion	2025-12-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-08