Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Mucous specimens will be collected from patients displaying symptoms of acute bacterial
sinusitis enrolled by primary care and/or otolaryngology clinics in the United States and
Australia. Health care professionals not having endoscopy certification will collect
specimens using the Entvantage sample collection device. Health care professionals with nasal
endoscopy certification or specialty training will collect comparator specimens using an
endoscope. Untrained operators with a range of education and training (primary care
physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or
other healthcare professional), will perform the Sinu-Test™ lateral flow assay in an
outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens
responsible for sinusitis using the Sinu-Test in the clinic and by the comparator method,
standard quantitative bacterial culture with identification (matrix-assisted laser
desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) by the central
laboratory. Qualitative real-time polymerase chain reaction (real-time PCR) of the residual
assay specimen will also be performed by the central laboratory.

An additional cohort of individuals not displaying symptoms of acute bacterial sinusitis or
illness will be included in the study to establish performance of the device with respect to
colonizing bacteria.

Inclusion Criteria:

- Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

Exclusion Criteria:

- Chronic sinusitis

- Cystic fibrosis

- Patients treated with antibiotics currently or within the previous 30 days.

- Subjects with a prior history of sinus surgery will be excluded due to the
modification of sinonasal anatomy.

- Primary immunodeficiencies, as self-reported

- Combined variable immunodeficiency

- Immunodeficiency with reduced immunoglobulin G (IgG) and immunoglobulin A
(IgA)-bearing cells

- Kartagener Syndrome (ciliary dyskinesia)

- Agammaglobulinemia

- Sickle cell disease

- Acquired immunodeficiencies, as self-reported

- Chemotherapy

- Radiation therapy

- Transplantation

- Asplenia

- HIV

- Poorly controlled Diabetes mellitus

- Cognitive impairment resulting in the inability to provide informed consent.

- Special groups, such as children under the age of 18, and men and women who are in
prison will not participate in this study.