Reducing Adenoviral Patient Infected Days (RAPID) Planning Study: Agreement between Clinician and AdenoPlus^TM in the Diagnosis of Adenoviral Conjunctivitis

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) AdenoPlus^TM, 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 AdenoPlus^TM (92% sensitivity), but diagnose a high proportion of eyes positive for Ad-Cs that are negative by AdenoPlus^TM (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.