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A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

NCT00921895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-11-03

Study results available
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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.

Conditions

Interventions

DEVICE

RPS Adeno Detector IV

One time test with the RPS Adeno Detector IV

Sponsors & Collaborators

  • Rapid Pathogen Screening

    lead INDUSTRY

Principal Investigators

  • Shachar Tauber, MD · St John's Clinic

  • Jodi Luchs, MD · South Shore Eye Clinic

  • William Trattler, MD · Center For Excellence In Eye Care

  • Thomas Boland, MD · Northeastern Eye Institute

  • Michael DellaVecchia, MD/PhD · Wills Eye Institute

  • Murray Friedberg, MD · Manatee Eye Clinic

  • Chris Starr, MD · Weill Medical College of Cornell University

  • Marguerite McDonald, MD · Ophthalmic Consultants of Long Island

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921895 on ClinicalTrials.gov