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

NCT07190131 | Completed FDA Device

• 1 other identifier: iH017
• Study Type: observational
• Target: 588
• Locations: 2 countries
• Sites: 15

Brief 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. 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. 2.What is the overall positive and negative percent agreement between the investigational test and the reference method?
3. 3.Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.
4. 4.Provide an additional specimen for testing with the FDA-cleared reference method.

Conditions

COVID - 19; Influenza A; Influenza B

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B and SARS-CoV-2 Compared to an FDA-Cleared Reference Method

  Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)

Interventions

Investigational Flu A/B And Covid-19 Diagnostic Test 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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with flu-like symptoms presenting to participating clinical sites

You may qualify if:

• Written informed consent obtained prior to study enrollment.
• Male or female aged 2 years or older
• Subject is currently exhibiting two or more symptoms associated with COVID-19 or influenza (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea) (and must present within 6 days of symptom onset- For Antigen assay only). Subject must still be exhibiting symptoms on the day of sample collection.

You may not qualify if:

• Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
• Subject has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
• Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
• Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
• Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
• Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days
• Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
• Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months

Sponsors & Collaborators

• iHealth Labs inc: lead

Study Sites (15)

iHealth Site 006

Birmingham, Alabama, 35242, United States

Location

iHealth Site 021

Trussville, Alabama, 35173, United States

Location

iHealth Site 017

Dublin, California, 94568, United States

Location

iHealth Site 007

Huntington Park, California, 90255, United States

Location

iHealth Site 008

Los Angeles, California, 90057, United States

Location

iHealth Site 013

Doral, Florida, 33122, United States

Location

iHealth Site 004

Fort Lauderdale, Florida, 33308, United States

Location

iHealth Site 005

Fort Lauderdale, Florida, 33312, United States

Location

iHealth Site 014

Tamarac, Florida, 33321, United States

Location

iHealth Site 009

Ammon, Idaho, 83406, United States

Location

iHealth Site 024

Smithfield, Pennsylvania, 15478, United States

Location

iHealth Site 020

Chattanooga, Tennessee, 37412, United States

Location

iHealth Site 003

Brownsville, Texas, 78520, United States

Location

iHealth Site 002

Edinburg, Texas, 78539, United States

Location

iHealth Site 001

Quebradillas, 00678, Puerto Rico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 24, 2025
• Study Start: November 12, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); PR (1)