Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-28 @ 1:17 PM
Study NCT ID:
NCT00921895
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2009-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Sponsor:
Rapid Pathogen Screening
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: