Trials / Completed
CompletedNCT00921895
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Rapid Pathogen Screening · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
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
The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RPS Adeno Detector IV | One time test with the RPS Adeno Detector IV |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2009-06-16
- Last updated
- 2021-11-03
- Results posted
- 2012-08-24
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00921895. Inclusion in this directory is not an endorsement.