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.
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
128
One time test with the RPS Adeno Detector IV
Manatee Eye Clinic
Bradenton, Florida, United States
Center For Excellence in Eye Care
Miami, Florida, United States
St John's Clinic
Springfield, Missouri, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
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.
Time frame: 15 minutes
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Weill-Cornell Medical College
New York, New York, United States
South Shore Eye Care
Wantagh, New York, United States
Wills Eye Institute
Philadelphia, Pennsylvania, United States
Northeastern Eye Institute
Scranton, Pennsylvania, United States