Trial Outcomes & Findings for A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis (NCT NCT00921895)

Results Overview

Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

15 minutes

Results posted on

2021-11-03

Participant Flow

The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers.

Participant milestones

Participant milestones
Measure	Device Testing Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
Overall Study STARTED	128
Overall Study COMPLETED	128
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Testing n=128 Participants Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
Age, Customized	43 years n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	128 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.

Outcome measures

Outcome measures
Measure	RPS Adeno Detector IV (Sensitivity) n=31 Participants Looking for the number of true positives as compared to cell culture.	RPS Adeno Detector IV (Specificity) n=97 Participants Looking for the number of true negatives as compared to cell culture.
Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.	90 percentage of cases Interval 74.2 to 98.0	96 percentage of cases Interval 89.8 to 98.9

Adverse Events

Device Testing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Sambusky, MD

Rapid Pathogen Screening, Inc.

Phone: 941-556-1853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results to be published or presented shall be submitted to RPS for review and comment at least 30 days prior to submission for publication or presentation. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after RPS confirms there will be no multicenter study publication, whichever occurs first.
Publication restrictions are in place

Restriction type: OTHER