The goal of this study is to evaluate the performance of the COVID/Flu Detect™ RapidSelf-Test when used in a home-like setting by lay users. The COVID/Flu Detect™ RapidSelf-Test is an investigational device intended for the qualitative detection anddifferentiation of SARS-CoV-2, influenza A, and influenza B protein antigens in nasalswab samples. Participants who are aged two (2) years and older and have symptoms ofrespiratory illness consistent with SARS-CoV-2 and influenza infection may be enrolled.Participants will use the COVID/Flu Detect™ Rapid Self-Test to self-collect, self-test,and interpret the results. Participants will have a nasal swab sample collected by ahealthcare provider for comparator testing by PCR tests for SARS-CoV-2, influenza A, andinfluenza B. Researchers will compare the results of the COVID/Flu Detect™ RapidSelf-Test obtained by the participants to results from the PCR comparator tests toevaluate performance.
This study will be a multi-site, all-comers, clinical trial assessing the positive
percent agreement (PPA) and negative percent agreement (NPA) of the COVID/Flu Detect™
Rapid Self-Test, an investigational qualitative lateral flow immunoassay intended for
non-prescription over-the-counter (OTC) use. Participants who are aged 2 years and older
and meet the eligibility criteria will be enrolled for testing on the COVID/Flu Detect™
Rapid Self-Test and for comparator testing on (1) an FDA-cleared or emergency use
authorized (EUA) SARS-CoV-2 RT-PCR test, (2) an FDA-cleared influenza A RT-PCR test, and
(3) an FDA-cleared influenza B RT-PCR test.
After obtaining informed consent, participants' age, sex, days post-symptom onset, signs
and symptoms of respiratory illness, comorbidities, any medications taken or
administered, influenza/COVID-19 vaccination history, race/ethnicity, socioeconomic
status, and educational background will be collected. Next, two (2) anterior nasal swab
samples will be collected from each participant, with at least a 15-minute normalization
period between swab sample collections. One (1) of the nasal swab samples will be
collected by a healthcare provider (HCP) from the participant. This nasal swab sample
will be sent for comparator testing. The other nasal swab sample will be self-collected
or collected by the participant's parent or legal guardian. Adults (participants aged 18
years or older) and older children (participants aged 14-17 years) will self-collect a
nasal swab sample by swabbing both nostrils and will test the swab sample themselves on
the COVID/Flu Detect™ Rapid Self-Test. For child participants aged 2-13 years, parents or
legal guardians will collect a nasal swab sample from their child by swabbing both
nostrils and will test the swab sample on behalf of their child on the COVID/Flu Detect™
Rapid Self-Test. The order of collection of the two nasal swab samples will be
randomized. A third nasal swab sample may be collected by the participant or the
participant's parent, if the first COVID/Flu Detect™ Rapid Self-Test result is invalid.
Study staff will observe participants while they self-collect their nasal swab sample and
perform the COVID/Flu Detect™ Rapid Self-Test, but participants will not be given any
assistance or guidance on these procedures by the study staff.
Diagnostic Test: COVID/Flu Detect™ Rapid Self-Test
The COVID/Flu Detect™ Rapid Self-Test is an investigational qualitative lateral flow
immunoassay designed for the detection and differentiation of SARS-CoV-2, influenza A,
and influenza B protein antigens in nasal swab samples. It is intended for
non-prescription over-the-counter (OTC) use.
Inclusion Criteria:
- Subjects must be at least 18 years of age, or at least 2 years of age and
accompanied by parent or legal guardian.
- Subjects must be willing and able to give informed consent or assent (as
age-appropriate).
- Subjects must be able to read/speak English (or Spanish at specific sites) if
subject is an adult, minor aged 14 years or older, or parent/guardian of a child
subject aged 2 through 13 years.
- Subjects must be currently exhibiting at least two of the following symptoms
consistent with possible SARS-CoV-2 or influenza infection: fever or feeling
feverish (in absence of documented fever), chills, cough, shortness of breath or
difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or
smell, sore throat, nasal congestion or runny nose, nausea or vomiting, and/or
diarrhea. Subjects must be within 5 days of symptoms onset at enrollment (the day
that symptoms start is day 0).
Exclusion Criteria:
- Subject was previously enrolled in this study.
- Subject has undergone a nasal wash or nasal aspirate procedure on day of enrollment.
- Subject has an active nosebleed.
- Subject has received results of an influenza or COVID-19 test within the previous 5
days.
Cahaba Research
Birmingham, Alabama, United States
Medicus Health Research Group Inc
Miami, Florida, United States
ASR, LLC
Boise, Idaho, United States
Barnes-Jewish Hospital
St. Louis, Missouri, United States
St. Louis Children's Hospital
St. Louis, Missouri, United States
Washington University School of Medicine
St. Louis, Missouri, United States
CHEAR Center LLC.
Bronx, New York, United States
Ichan School of Medicine at Mount Sinai, Department of Emergency Medicine
New York, New York, United States
Eastside Research Associates
Midland, Texas, United States
ERA Health Research
Odessa, Texas, United States
Not Provided