Last updated on November 2018

Point-of-Care Immunoassay for Detection of Bacterial Sinusitis


Brief description of study

This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.

Detailed Study Description

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.

Clinical Study Identifier: NCT03584737

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Sheetal Bull

Paratus Clinical Kippa Ring Clinic
Kippa-Ring, Australia
3.88miles
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