Approximately 2,000 symptomatic Participants to achieve at least 80 COVID-19 PCR
confirmed positives, 80 Flu A PCR confirmed positives, 80 Flu B PCR confirmed positives,
and 500 COVID-19 and Influenza PCR-confirmed negatives.

Site staff will collect two (2) anterior nasal swabs from each Participant from whom
informed consent has been obtained. Participants ages two (2) years and older meeting
eligibility criteria will be enrolled.

One anterior nasal swab will be immediately eluted in an extraction buffer tube and
tested with the Panbio™ COVID-19/Flu A&B Panel. If immediate testing is not possible, the
swab specimen can be kept in an extraction buffer tube filled with extraction buffer at
room temperature (59-86°F /15-30 °C) for up to one (1) hour prior to testing.

The other anterior nasal swab will be rotated vigorously in VTM, and the swab head will
be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary.

Anterior nasal swab sample collection will be as follows:

With the swab designated for Panbio testing, use gentle rotation to push the swab into
the right nostril until resistance is met at the level of the turbinates (less than one
inch into the nostril). Rotate the swab several times against the nasal wall then slowly
remove from the nostril. Using the swab designated for PCR testing, repeat sample
collection in the left nostril.

With the swab designated for PCR testing, use gentle rotation to push the swab into the
right nostril until resistance is met at the level of the turbinates (less than one inch
into the nostril). Rotate the swab several times against the nasal wall then slowly
remove from the nostril. Using the swab designated for Panbio testing, repeat sample
collection in the left nostril.

The VTM samples will be stored, handled, and tested with comparator assays according to
the manufacturers' product instructions. VTM 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.

Swab eluate samples containing the swab head in VTM will be tested at the central
laboratory with the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B
Assay (K230236) per product instructions. All discordant samples (i.e., samples with the
Roche cobas® SARS-CoV-2 (K231306) or Quidel Lyra® Influenza A+B Assay (K230236) results
that conflict with the Panbio™ COVID-19/Flu A&B Panel results) will be evaluated with the
Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System) for information only.
Samples may also be tested for viral culture.

Note: For the purposes of the COVID-19 method comparison, Roche cobas® SARS-CoV-2 results
will be interpreted per the package insert. Roche cobas® SARS-CoV-2 results where the
ORF1a/b (Target 2) is Negative or Invalid and the E-Gene (Target 3) is Positive are
considered Presumptive Positive for COVID-19. These samples will be further evaluated
with the Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System).

Each Participant's demographic data, inclusion/exclusion data, days of symptom onset,
comparator results, Panbio™ COVID-19/Flu A&B Panel results and other data elements will
be recorded as detailed in Section 10 of this document. Defined Participant data will be
recorded on source documentation and entered into an Electronic Data Capture (EDC)
system. Panbio™ results and the comparator method results will not be provided to study
Participants. Panbio™ COVID-19/Flu A&B Panel test operators will be blinded to a
Participant's standard of care COVID-19 and/or Flu test results.