Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:55 AM
Study NCT ID:
NCT07308158
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid Flu A/B and RSV 4 in 1 Diagnostic Test
Sponsor:
iHealth Labs inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: