The total number of anterior nasal swabs collected from each consented Participant is two
(2). Participants at least two (2) years of age 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 Panbio™ COVID-19/Flu A&B Panel Self Test and which is to be
eluted into VTM for comparator testing. Site staff should allow for a minimum 15 minute
period between the 2 swabs to allow for normalization of the swabbing site. For
Participants with an odd numbered Participant ID, the first swab collected will be used
for Panbio™ COVID-19/Flu A&B Panel Self Test and the second swab collected will be eluted
into VTM for comparator testing. For Participants with an even numbered Participant ID,
the first swab collected will be eluted into VTM for comparator testing and the second
swab collected will be used for Panbio™ COVID-19/Flu A&B Panel Self Test.

Sample collection for the Self Test:

Each Participant (lay user who will be a self-tester or caregiver) from whom informed
consent has been obtained will be provided a single use test kit containing a Panbio™
COVID-19/Flu A&B Panel Self Test and a sterile nasal swab. The Participant will
self-collect one (1) anterior nasal swab, perform the Panbio™ COVID- 19/Flu A&B Panel
Self Test, then interpret and record the result. Parents of pediatric participants under
the age of 14 or Legally Authorized Representatives of adult Participants unable to
perform self-collection will collect one (1) anterior nasal swab from the Participant,
perform the Panbio™ COVID-19/Flu A&B Panel Self Test, then interpret and record the
result. To simulate a home environment testing will occur in a designated room/area that
does not contain medical equipment. The designated room/area will at minimum contain a
table/counter, chair and lamp for testing. The participant will be provided with the
Instructions for Use prior to testing. Participants will not be able to observe other
participants conducting testing. The Participant will follow Panbio instructions to
insert the swab up to one inch first into the right nostril, to rotate/swirl the swab
five (5) times to obtain sample, then remove and insert the same swab into the left
nostril, repeating the rotate/swirl technique. After sample collection, Participants will
test the sample on the Panbio™ COVID-19/Flu A&B Panel Self Test and interpret the
results. Participants will be asked to document their result interpretation, and will
pass the completed test to site staff, who will independently and separately document
their interpretation of the result. Site staff will interpret the test immediately and at
the same time photograph the test result. Site staff will be blinded to the test result
recorded by the Participant. Participants/lay users, caregivers, and site staff will be
blinded to a Participant's standard of care COVID-19 and/or Flu test results.

Sample collection for the comparator:

Site staff will collect one (1) anterior nasal swab from the Participant by inserting the
swab 1-2 cm into one of the anterior nares. Staff will rotate the swab against the nasal
mucosa for about 3 seconds and withdraw. Staff will repeat with the other anterior nare
using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM). VTM
will be send to the central lab and be tested with reverse transcriptase - Polymerase
Chain Reaction (RT-PCR).