NCT07308158

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,119 (actual)
• Sponsor: iHealth Labs inc · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Influenza A
• Influenza B
• COVID - 19
• RSV

Interventions

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

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-12-12
• Completion: 2025-12-12
• First posted: 2025-12-29
• Last updated: 2026-01-08

Locations

23 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study