First and only CLIA-waived point-of-care diagnostic test that aids in the rapid differential diagnosis of acute conjunctivitis.
Helps to reduce conjunctivitis misdiagnosis, allowing for appropriate management based on diagnostic evidence.
Detection of adenoviral conjunctivitis
AdenoPlus® accurately detects adenovirus, which accounts for up to 90% of all viral conjunctivitis, and approximately one out of four cases of acute conjunctivitis seen by eyecare practitioners1. AdenoPlus® can offer eyecare professionals an efficient and effective method to diagnose and manage patients with an acute red eye.
An accurate diagnosis for better patient care
An accurate diagnosis enables clinicians to make better therapeutic decisions based on diagnostic evidence and allows patients to leave the clinician’s office better informed and better prepared, knowing if their red eye is adenovirus and whether they can return to school or work.
Rapid results obtained in ten minutes or less
AdenoPlus® has 90% sensitivity and 96% specificity2. It is fast and easy-to-use. The simple, four-step process takes less than two minutes to complete and provides a definite result in ten minutes or less.
Conjunctivitis misdiagnosis and consequences
It has been estimated that at least 6 million cases of acute conjunctivitis are diagnosed in the US each year3 and studies indicate that eyecare professionals make an accurate clinical diagnosis approximately 50% of the time1. This is because viral, bacterial, and allergic conjunctivitis – the most common types – manifest similarly, making differential diagnosis using only signs and symptoms challenging (see image below1,7,8).
Misdiagnosis represents a major problem; as adenovirus is highly contagious and associated with significant morbidity, including decreased visual acuity, light sensitivity, chronic excessive tear production, visual loss and presence of subepithelial infiltrates4-6.
The majority of acute conjunctivitis cases result in a prescription for antibiotics, even in viral cases when antibiotics are not necessary. Inappropriate antibiotic use may increase adverse effects, promote resistance and add avoidable costs to the healthcare system1.
More information on AdenoPlus® in the United States
The information below is intended to U.S. eyecare professionals only.
The US Food and Drug Administration (FDA) granted 510(k) clearance to AdenoPlus™ in May 2011; AdenoPlus® can therefore be marketed in the US. In addition, AdenoPlus® was granted waived status under the Clinical Laboratory Improvement Amendments (CLIA) in April 2012.
For more information or to order AdenoPlus®, please call 1.855.MY.NICOX (1.855.696.4269).
- Package insert – Instructions for use: English
- Decode the Red Eye – AdenoPlus brochure
- Quick Reference Guide
RPS® is responsible for marketing and selling AdenoPlus™ in the U.S. to primary and urgent care physicians. If you are a U.S. primary or urgent care doctors, please visit RPSdetectors.com.
More information on AdenoPlus® in Europe and in the rest of the world
AdenoPlus® is CE-marked and is available for sale by Nicox or its distributors in Europe and other countries.
For any information on AdenoPlus® in Europe or other countries outside of North America, please contact Nicox Pharma.
1 O’Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug; 25(8):1953-61.
2 FDA Section 510k number (K110722) for RPS Adeno Detector Plus™; March 15, 2011.
3 Udeh BL, Schneider JE, Ohsfeldt RL. Cost effectiveness of a point-of-care test for adenoviral conjunctivitis. Am J Med Sci. 2008 Sep;336(3):254-64.
4 Butt AL, Chodosh J. Adenoviral keratoconjunctivitis in a tertiary care eye clinic. Cornea. 2006 Feb;25(2):199-202.
5 Hyde KJ, Berger ST. Epidemic keratoconjunctivitis and lacrimal excretory system obstruction. Ophthalmology. 1988 Oct;95(10):1447-9.
6 Hammer LH, Perry HD, Donnenfeld ED, et al. Symblepharon formation in epidemic keratoconjunctivitis. Cornea. 1990 Oct;9(4):338-40.
7 Fitch CP, Rapoza PA, Owens S, et al. Epidemiology and diagnosis of acute conjunctivitis at an inner-city hospital. Ophthalmology. 1989 Aug;96(8):1215-20.
8 Gigliotti F, Williams WT, Hayden FG, et al. Etiology of acute conjunctivitis in children. J Pediatr. 1981 Apr;98(4):531-6.
FDA: Food and Drug Administration
510(k) is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.
CLIA: The Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A waiver signifies that the test has been classified as a low complexity device, which allows medical office personnel of CLIA-waived offices (not only physicians) to perform it.