Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

Study Overview
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Brief Summary
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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 Description
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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. 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 a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.

Official Title
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Multi-Center Study of a Point-of-Care Immunoassay for the Detection of Bacterial Sinusitis

Conditions
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Sinusitis Bacterial

Intervention / Treatment
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* Diagnostic Test: rapid in vitro diagnostic test
* Diagnostic Test: bacterial culture
* Diagnostic Test: PCR assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic for bacterial sinusitis<br>Samples from participants showing symptoms of bacterial sinusitis tested by rapid in vitro diagnostic test, bacterial culture, and PCR assay | Diagnostic Test: rapid in vitro diagnostic test<br>* IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)<br>* Other names: Sinu-Test®;Diagnostic Test: bacterial culture<br>* Quantitative bacterial culture assay with isolate identification by MALDI-TOF.<br>Diagnostic Test: PCR assay<br>* Semiquantitative real-time PCR assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity (positive predictive agreement) and specificity (negative predictive agreement) of the diagnostic device | Assessment of the true positive and true negative rate of the point-of-care test device relative to the composite reference standard for each of the 3 bacterial microorganisms. | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value (PPV) and negative predictive value (NPV) | Positive predictive value is the probability that subjects with a positive point-of-care test truly have the bacteria present. Negative predictive value is the probability that subjects with a negative point-of-care test truly do not have the bacteria present. | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | 
| Positive likelihood ratio (LR+) and negative likelihood ratio (LR-) | LR+ is equivalent to the probability of a true positive result divided by the probability of a false positive result. LR- is equivalent to the probability of a false negative result divided by the probability of a true negative result. | Cumulation of one-time subject sample results obtained in 20-30 minutes for point-of-care test and 3-5 days for lab results | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute sinusitis, bacterial sinusitis, point-of-care, in vitro diagnostic device (IVD)