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
Brief Summary

The goal of this observational study is to evaluate the diagnostic performance of aninvestigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms ofrespiratory 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.

Detailed Description

Not Provided

Completed
Influenza A
Influenza B
COVID - 19
RSV

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.

Eligibility Criteria

Inclusion Criteria:

- Written informed consent obtained prior to study enrollment.

- Male or female aged six (6) months or older.

- Subject is currently exhibiting two or more symptoms associated with COVID-19,
influenza or RSV (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 six
(6) days of symptom onset). 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 and/or the RSV 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®), or 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: 6 Months ~ Maximum: N/A
Countries
Puerto Rico
United States
Locations

iHealth Site 006
Birmingham, Alabama, United States

iHealth Site 021
Trussville, Alabama, United States

iHealth Site 017
Dublin, California, United States

iHealth Site 007
Huntington Park, California, United States

iHealth Site 026
Toluca Lake, California, United States

iHealth Site 011
DeLand, Florida, United States

iHealth Site 013
Doral, Florida, United States

iHealth Site 004
Fort Lauderdale, Florida, United States

iHealth Site 005
Fort Lauderdale, Florida, United States

iHealth Site 019
Palm Springs, Florida, United States

iHealth Site 014
Tamarac, Florida, United States

iHealth Site 009
Ammon, Idaho, United States

iHealth Site 027
Edison, New Jersey, United States

iHealth Site 015
Simpsonville, South Carolina, United States

iHealth Site 016
Spartanburg, South Carolina, United States

iHealth Site 020
Chattanooga, Tennessee, United States

iHealth Site 003
Brownsville, Texas, United States

iHealth Site 002
Edinburg, Texas, United States

iHealth Site 018
El Paso, Texas, United States

iHealth Site 023
Mesquite, Texas, United States

iHealth Site 025
Morgantown, West Virginia, United States

iHealth Site 001
Quebradillas, Puerto Rico

iHealth Site 022
San Juan, Puerto Rico

Not Provided

iHealth Labs inc
NCT Number
MeSH Terms
COVID-19