A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

Study Overview
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Brief Summary
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To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.

Detailed Description
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The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.

Official Title
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A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.

Conditions
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Conjunctivitis

Intervention / Treatment
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* Device: RPS Adeno Detector IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study. Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below: I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI) II Signs: 1) presence of follicles, 2) presence of a preauricular node III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation Exclusion Criteria: Patients with allergy to corn starch, talcum powder, or dacron will be excluded. Patients with a corneal ulcer or history of recent trauma will also be excluded. Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded. Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.

Ages Eligible for Study
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Minimum Age: 1 Year

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Testing<br>Patients with conjunctivitis will be tested with the RPS Adeno Detector IV | Device: RPS Adeno Detector IV<br>* One time test with the RPS Adeno Detector IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture. | Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pink Eye,, Viral conjunctivitis, Adenoviral conjunctivitis, Keratoconjunctivitis