Official Title
Evaluation of iHealth COVID-19/Flu A&B Rapid Test for SARS-CoV-2 and Flu A&B Detection in Symptomatic Individuals
Brief Summary

This observational study aims to evaluate the diagnostic performance of aninvestigational Influenza A/B and COVID-19 test in patients presenting with signs andsymptoms 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.

Detailed Description

Not Provided

Recruiting
COVID - 19
Influenza A
Influenza B

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years ~ Maximum: N/A
Countries
Puerto Rico
United States
Locations

iHealth Site 006
Birmingham 4049979, Alabama 4829764, United States

iHealth Site 021
Trussville 4094212, Alabama 4829764, United States

iHealth Site 017
Dublin 5344157, California 5332921, United States

iHealth Site 007
Huntington Park 5358736, California 5332921, United States

iHealth Site 008
Los Angeles 5368361, California 5332921, United States

iHealth Site 011
DeLand 4152890, Florida 4155751, United States

iHealth Site 013
Doral 4153471, Florida 4155751, United States

iHealth Site 004
Fort Lauderdale 4155966, Florida 4155751, United States

iHealth Site 005
Fort Lauderdale 4155966, Florida 4155751, United States

iHealth Site 014
Tamarac 4174738, Florida 4155751, United States

iHealth Site 009
Ammon 5583997, Idaho 5596512, United States

iHealth Site 012
Idaho Falls 5596475, Idaho 5596512, United States

iHealth Site 024
Smithfield 4561301, Pennsylvania 6254927, United States

iHealth Site 015
Simpsonville 4595864, South Carolina 4597040, United States

iHealth Site 016
Spartanburg 4597200, South Carolina 4597040, United States

iHealth Site 020
Chattanooga 4612862, Tennessee 4662168, United States

iHealth Site 003
Brownsville 4676740, Texas 4736286, United States

iHealth Site 002
Edinburg 4688275, Texas 4736286, United States

iHealth Site 001
Quebradillas 4567552, Puerto Rico

Not Provided

iHealth Labs inc
NCT Number
MeSH Terms
COVID-19