Conjunctivitis Clinical Trial
Official title:
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.
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis. ;
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