A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 1 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2009 |
End Date: | June 2011 |
A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
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.
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.
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing
adenoviral conjunctivitis.
adenoviral conjunctivitis.
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.
We found this trial at
8
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials