The study is designed as a clinical feasibility, to investigate the positive and negativepercent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A&B Combo against a highlysensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenzainfection when nasal swabs are self-collected by the patient/lay user.
Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID
PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza
PCR negatives.
The total number of research-related anterior nasal swabs collected from each consented
Participant is two (2). Participants ages two (2) years and older meeting eligibility
criteria will be enrolled.
The order of nasal swab collection will be randomized according to the Participant ID as
to which swab is used for BinaxNOW™ COVID-19/Flu A&B Combo and which is to be eluted into
VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for
comparator testing.
For Participants with an odd numbered Participant ID, the first swab will be
self-collected and used for the BinaxNOW™ COVID-19/Flu A&B Combo. The second swab will be
collected by a healthcare professional and eluted into VTM/UTM and will have the swab
head left in the media (snap off or clip shaft) for comparator testing. The Participant
will review the Instructions for Use, collect the nasal swab, and perform the BinaxNOW™
COVID-19/Flu A&B Combo, then interpret and record the result at the time specified in the
product instructions.
For Participants with an even numbered Participant ID, the first swab will be collected
by a healthcare professional and eluted into VTM/UTM and will have the swab head left in
the media (snap off or clip shaft) for comparator testing. The second swab will be
self-collected and used for the BinaxNOW™ COVID-19/Flu A&B Combo. Once the healthcare
provider collected the swab for the comparator test the Participant will review the
Instructions for Use.
The VTM/UTM samples will be stored, handled, and tested with comparator assays according
to the manufacturers' product instructions. VTM/UTM specimens can be stored for up to 48
hours at 2-8°C. If delivery and processing of samples exceeds specified time periods,
specimens should be transported in dry ice and once in laboratory frozen at -70°C or
colder.
Each Participant's demographic data, inclusion/exclusion data, days of symptom onset,
comparator results, Education level, occupation, and socioeconomic status and other data
points will be documented on the data collection worksheets and EDC.
Diagnostic Test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test
Diagnostic Test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test
The BinaxNOW™ COVID-19/Flu A&B Combo Self-Test is a visually read lateral flow in vitro
immunoassay for the qualitative detection and differentiation of the nucleocapsid protein
antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab
specimens from individuals with signs and symptoms of respiratory infection.
Inclusion Criteria:
- Participant is at least two (2) years of age, AND Participant is suspected of acute
viral respiratory infection by a healthcare professional, AND
- Participant is within five (5) days of symptom onset, AND
Participant is experiencing two or more of the following symptoms:
Fever of >100.0°F/ 37.8°C or chills, Cough, Fatigue, New loss of taste or smell,
Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat,
Muscle or body aches, Headache
-The Participant and/or legally authorized representative is willing to undergo the
informed consent/Assent process prior to study participation. A minor will need the
documented consent of their parent or legal guardian unless the site has an HREC waiver
for parental consent for minors.
Exclusion Criteria:
- Participant is currently enrolled in a study to evaluate an investigational drug or
experimental treatment
- Participants with an active nosebleed
- Participant has undergone a nasal wash or nasal aspirate procedure on day of
enrolment
- Participant has tested positive for COVID-19 within the last 45 days
- Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.
- Participant has received antiviral medications for Influenza (Amantadine,
Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days.
- Participant has received medication or treatment for COVID-19 infection in the last
45 days (including antivirals (such as Paxlovid), convalescent plasma therapy,
monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB)
treatment (Evusheld)
- Participant is unable to meet all inclusion criteria as listed above
Not Provided
Samantha Parsons, Manager of Clinical Operations
000-000-0000
samantha.parsons@abbott.com
Not Provided