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.

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.

Study Overview

• Status: Completed
• Conditions: Conjunctivitis
• Intervention / Treatment: Device: RPS Adeno Detector IV

Detailed Description

The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34208
      • Manatee Eye Clinic
    • Miami, Florida, United States, 33176
      • Center for Excellence in Eye Care
  • Missouri
    • Springfield, Missouri, United States, 65804
      • St John's Clinic
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • New York, New York, United States, 10021
      • Weill-Cornell Medical College
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institute
    • Scranton, Pennsylvania, United States, 18503
      • Northeastern Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
• Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:

I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)

II Signs: 1) presence of follicles, 2) presence of a preauricular node

III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation

Exclusion Criteria:

• Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
• Patients with a corneal ulcer or history of recent trauma will also be excluded.
• Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
• Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Testing; Patients with conjunctivitis will be tested with the RPS Adeno Detector IV	Device: RPS Adeno Detector IV; One time test with the RPS Adeno Detector IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes

Collaborators and Investigators

• Sponsor: Rapid Pathogen Screening
• Investigators: Principal Investigator: William Trattler, MD, Center for Excellence in Eye Care; Principal Investigator: Shachar Tauber, MD, St John's Clinic; Principal Investigator: Jodi Luchs, MD, South Shore Eye Clinic; Principal Investigator: Thomas Boland, MD, Northeastern Eye Institute; Principal Investigator: Michael DellaVecchia, MD/PhD, Wills Eye Institute; Principal Investigator: Murray Friedberg, MD, Manatee Eye Clinic; Principal Investigator: Chris Starr, MD, Weill Medical College of Cornell University; Principal Investigator: Marguerite McDonald, MD, Ophthalmic Consultants of Long Island

Publications and helpful links

General Publications

• Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513. Erratum In: JAMA Ophthalmol. 2013 Mar;131(3):320.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 14, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 16, 2009

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Keratoconjunctivitis; Adenoviral conjunctivitis; Viral conjunctivitis; Pink Eye,
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: 200-003