Idylla IFV-RSV Panel Clinical Testing

The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the
Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular
diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A
(including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory
Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal
swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.

This clinical study will collect data in support of regulatory submission and the
indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol
will demonstrate that the results of this assay, in conjunction with clinical information,
may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV
in persons having both a high and low risk for respiratory viral infection.

During this study, participating sites will collect fresh samples, conduct a Reproducibility
Study and test the fresh and previously collected frozen samples from individuals presenting
with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to
the sample collection described in this protocol.

Inclusion Criteria:

- Male or Female

- All Ages

- Subject, or legally authorized representative, has provided IRB/EC approved written
Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where
applicable prior to any study-related procedure(s) being performed

- Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this
protocol

- Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject
screening (Refer to the definitions for detailed descriptions of ILI and
Signs/Symptoms of RSV infection)

- Clinician's determination that illness is due to a viral infection

- Subject agrees to allow study specimens to be used for future studies

Exclusion Criteria:

- Onset of Influenza Like Illness (ILI) and/or Signs/Symptoms of RSV Infection was > 5
days prior to subject screening (Refer the definitions for detailed descriptions of
ILI and Signs/Symptoms of RSV infection)

- Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g.
FluMist, Fluenz)

- Subject received treatment with influenza directed antiviral (e.g. Zanamivir,
oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days

- The subject was previously enrolled in this study

- Clinician's determination that illness is NOT due to a viral infection (e.g.
allergies)

- Subject had a nasal wash within last 8 hours. This exclusion includes any extraction
of nasal secretions by nasal suctioning with fluid

- Subject does not agree to allow study specimens to be used for future research
studies