September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Reducing Adenoviral Patient Infected Days (RAPID) Planning Study: Agreement between Clinician and AdenoPlusTM in the Diagnosis of Adenoviral Conjunctivitis
Author Affiliations & Notes
  • Mary Migneco
    Ophthalmology, Washington University in St. Louis, St. Louis, Missouri, United States
  • Mae O Gordon
    Ophthalmology, Washington University in St. Louis, St. Louis, Missouri, United States
  • Andrew T E Hartwick
    Optometry, Ohio State University , Columbus, Ohio, United States
  • Spencer Johnson
    Optometry, Northeastern State University, Tahlequah, Oklahoma, United States
  • Jennifer Harthan
    Optometry, Illinois College of Optometry, Chicago, Illinois, United States
  • Christina Morettin
    Optometry, Illinois College of Optometry, Chicago, Illinois, United States
  • Tammy Than
    Optometry, University of Alabama, Birmingham, Birmingham, Alabama, United States
  • Ellen Shorter
    Ophthalmology, Illinois Eye and Ear Infirmary, Chicago, Illinois, United States
  • Julie Huecker
    Ophthalmology, Washington University in St. Louis, St. Louis, Missouri, United States
  • Footnotes
    Commercial Relationships   Mary Migneco, None; Mae Gordon, None; Andrew Hartwick, None; Spencer Johnson, None; Jennifer Harthan, None; Christina Morettin, None; Tammy Than, None; Ellen Shorter, None; Julie Huecker, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3503. doi:
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      Mary Migneco, Mae O Gordon, Andrew T E Hartwick, Spencer Johnson, Jennifer Harthan, Christina Morettin, Tammy Than, Ellen Shorter, Julie Huecker; Reducing Adenoviral Patient Infected Days (RAPID) Planning Study: Agreement between Clinician and AdenoPlusTM in the Diagnosis of Adenoviral Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3503.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Adenoviral conjunctivitis (Ad-Cs) is a prevalent and contagious eye infection for which there is no FDA-approved treatment. RAPID is a 2-year multi-center planning study that will provide key parameters for a double-masked randomized trial that definitively tests whether 5% Betadine, as compared to artificial tears, is an effective treatment for Ad-Cs. Accurate diagnosis of Ad-Cs is required for eligibility determination. We compare clinician diagnosis of Ad-Cs to (Rapid Pathogen Screening) AdenoPlusTM, an FDA-approved, point-of-care immunoassay for the diagnosis of Ad-Cs.

Methods : Eligibility includes consent, age ≥ 18 years, presentation with a red eye and symptom onset ≤ 4 days. Participants complete a symptom survey. Clinical evaluation including visual acuity, lymph node palpation, and slit lamp examination is performed. Clinicians predict cause of red eye based on clinical signs and patient reported symptoms. Options include bacterial, allergic, dry eye, environmental irritation, contact lens related, or adenoviral. Each option is rated "definitely not", "probably not", "probably yes", or "definitely yes". For this report, "probably" and "definitely" options were pooled. Eligible participants who tested AdenoPlus positive were randomized to either ocular lavage with 5% povidone-iodine (Betadine) or artificial tears (Refresh Optive). Participants completed follow-up visits at 1-2, 4, 7, 14 and 21 days with clinicians masked to treatment. Conjunctival swab samples are obtained at all visits and sent for qPCR analysis to assess adenoviral load.

Results : Over the first 37 weeks, 34 participants (76% female) with presumed Ad-Cs were screened. The mean age was 40.9 ± 14.2 years. Clinicians predicted an adenovirus etiology in 12 of the 13 eyes (sensitivity = 92%) that tested AdenoPlus-positive and in 16 of the 21 eyes (false positive = 76%) that were AdenoPlus-negative. Clinicians predicted bacterial co-infection in 10 of the 35 eyes (29%). Of the 35 participants, 11 (31%) met eligibility criteria and were randomized. All participants completed follow-up to 21 days.

Conclusions : Preliminary data suggests that clinicians correctly diagnose eyes positive for Ad-Cs compared to AdenoPlusTM (92% sensitivity), but diagnose a high proportion of eyes positive for Ad-Cs that are negative by AdenoPlusTM (76% false positive rate).

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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