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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921895
• Other study ID #: 200-003
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2021
• Source: Lumos Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Other known NCT identifiers

• NCT00799318

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Conjunctivitis

Intervention

Device:
• RPS Adeno Detector IV
One time test with the RPS Adeno Detector IV

Locations

Country	Name	City	State
United States	Manatee Eye Clinic	Bradenton	Florida
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Center For Excellence in Eye Care	Miami	Florida
United States	Weill-Cornell Medical College	New York	New York
United States	Wills Eye Institute	Philadelphia	Pennsylvania
United States	Northeastern Eye Institute	Scranton	Pennsylvania
United States	St John's Clinic	Springfield	Missouri
United States	South Shore Eye Care	Wantagh	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Pathogen Screening

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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