DECODE THE RED EYE RAPID RESULTS FOR A CONFIDENT DIAGNOSIS

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1 New AdenoPlus aids in the rapid differential diagnosis of acute conjunctivitis, allowing for appropriate management based on diagnostic evidence

2 Viral, bacterial, or allergic the signs and symptoms of acute conjunctivitis can be indistinguishable It has been estimated that at least 6 million cases of acute conjunctivitis are diagnosed in the U.S. each year 1 Viral, bacterial, and allergic are the most common types and present similarly 2-4 Differential diagnosis using only signs and symptoms can be challenging 5-8 Overlap in clinical signs and symptoms of acute conjunctivitis 5,9,10 Purulent discharge Redness N/A 25% 28% 38% 81% 83% Viral Bacterial Allergic Early, accurate diagnosis of acute conjunctivitis may prevent serious consequences Adenovirus causes approximately 1 out of every 4 acute conjunctivitis cases seen by eye care professionals and is often misdiagnosed 2-5,11,12 Adenovirus is associated with significant morbidity, including 11,13-15 Decreased visual acuity Light sensitivity Chronic excessive tear production Visual loss Presence of subepithelial infiltrates Contagion with adenovirus is fast and widespread Infected patients are contagious for up to 3 weeks 16 Between close contacts the infection rate is up to 50% 16 Adenovirus can live on inanimate surfaces for up to 28 days 17,18 Mucoid discharge 19% 17% 18% Irritation/foreign body sensation 19% 17% 52% Watery discharge/tearing 50% 39% 48% Itching Follicles 38% 33% 86% 8% 47% 42% Studies indicate that eye care professionals make an accurate differential diagnosis for acute conjunctivitis approximately 50% of the time 2-4 The majority of acute conjunctivitis cases result in a prescription for antibiotics, even when they are unnecessary 19 Unnecessary antibiotic use may increase adverse effects and promote resistance 11 While some cases of acute conjunctivitis are more obviously associated with one etiology or another, the majority of cases have similar presentation, making the differential diagnosis challenging. Kelly Nichols, OD, MPH, PhD, FAAO Treatment of conjunctivitis is ideally directed at the root cause. Indiscriminate use of topical antibiotics or corticosteroids should be avoided, because antibiotics can induce toxicity and corticosteroids can potentially prolong adenoviral infections 18 American Academy of Ophthalmology (AAO), Preferred Practice Pattern, 2011

3 Introducing AdenoPlus the first in-office immunoassay that aids in the rapid differential diagnosis of acute conjunctivitis AdenoPlus in practice aiding in making an accurate diagnosis for better patient care Fast Quickly obtain accurate evidence for a differential diagnosis22 With AdenoPlus, eye care professionals can: 2 minutes to complete test; results in just 10 minutes Comply with AAO guidelines by counseling contagious patients to minimize or prevent spread of the disease in the community18 Accurate Significantly reduce cost to the U.S. healthcare system12 Identifies adenovirus (which accounts for 90% of all viral conjunctivitis2,20,21) with 90% sensitivity and 96% specificity A published cost-effectiveness study found that incorporating AdenoPlus as a routine, point-of-care test for the red eye could save more than $400 million annually Easy More effectively and efficiently manage their patients with red eye2,11,22 Completed in the office in 4 simple steps Providing accurate results in 4 simple steps An objective diagnosis may enhance the patient experience2 Patients know if their red eye is adenovirus before leaving the clinician s office They know whether or not they can return to work They may avoid paying for unnecessary treatments such as antibiotics AdenoPlus features proprietary technology utilizing direct sample microfiltration with a lateral flow assay strip, enabling a small sample of ocular fluid to aid in a rapid differential diagnosis in the office. 1. Use a dab and drag motion in 6 to 8 locations on the palpebral conjunctiva (lower eyelid) to collect a tear sample. 2. Snap the sample collector into the test cassette and press firmly where indicated. 3. Dip the test cassette into the provided buffer vial for 20 seconds. Replace the cap. With AdenoPlus, practices benefit from a laboratory-quality diagnosis at the point of care. [AdenoPlus ] helps reduce the number of misdiagnoses and leads to better patient management and treatment. 2 Paul Karpecki, OD, FAAO Terrence P. O Brien, MD 4. Read the results: 2 lines (1 red, 1 blue) = positive, 1 line (blue) = negative

4 THE RED EYE PROTOCOL* AdenoPlus helps provide effective diagnosis and management of the conjunctivitis patient11,18 AdenoPlus a fast and convenient way to aid in a rapid differential diagnosis The only CLIA-waived, in-office diagnostic tool for acute conjunctivitis Can be performed by nurses, technicians, or any trained medical office personnel Red Eye Room Isolation History and Evaluation Reimbursable in the U.S. with CPT code 87809QW Identification and isolation of patient by front office linical signs and symptoms and their duration (itching, tearing, discharge, irritation, pain, photophobia, blurred vision) Recent exposure to infected individual Recent upper respiratory infection T rauma, contact lens wear, or presence of systemic conditions Use of medications Cost effective, requiring no ancillary equipment If acute conjunctivitis is determined, perform AdenoPlus test Diagnostic Testing Reimbursement for AdenoPlus Facilities must obtain CLIA-waived certification for reimbursement Reimbursement guide for AdenoPlus Technician performs AdenoPlus ( 2 min to complete; results in just 10 minutes) 1. Enter CLIA-waived certification number ECP interprets test results and determines appropriate treatment based on diagnostic evidence Positive Negative Consider nonantibiotic therapy Patient counseling: isolation (7 to 10 days); hand washing; no towel sharing or close contact Supportive care: artificial tears, antihistamines, cold compresses, or topical corticosteroids with close patient monitoring Implementation of CDC guidelines for decontamination of exposed surfaces and equipment in the ECP office ontinue the differential diagnosis (with adenovirus ruled out) to determine likelihood of bacterial or allergic onsider topical antibiotic or antihistamine therapy, or a combination F ollow up or refer if decreased vision or pain, or lack of improvement over 7 days CDC=Centers for Disease Control *The Red Eye Protocol was developed based on published literature of best practices in managing the acute red eye. Enter AdenoPlus test description Infectious agent antigen detection by immunoassay with direct optical observation; adenovirus Enter CPT code and qualifier: 87809QW 3. Enter an appropriate ICD-9 code CLIA=Clinical Laboratory Improvement Amendments The most important reason for early detection of conjunctivitis is that prompt, appropriate treatment speeds resolution of the disease, minimizing both the sequelae of untreated conjunctivitis and time away from work or school. 18 American Academy of Ophthalmology (AAO), Preferred Practice Pattern, Modify the master bill: Implementation of an in-office red eye protocol and point-of-care diagnostic tools, such as AdenoPlus, can greatly improve the treatment and management of conjunctivitis patients. Mile Brujic, OD

5 Introducing AdenoPlus rapid results for a confident diagnosis Fast: Results in just 10 minutes Accurate: 90% sensitivity and 96% specificity Easy: Complete in the office in 4 simple steps R ED EYE PROTOCOL: Helps provide effective diagnosis and management For more information or to order AdenoPlus, contact your local Ophthalmic Account Manager or call MY.NICOX ( ). References: 1. Data on file, Nicox Ophthalmic Diagnostics. 2. O Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009;25(8): Leibowitz HM, Pratt MV, Flagstad IJ, et al. Human conjunctivitis. Arch Ophthalmol. 1976;94: Stenson S, Newman R, Fedukowicz H. Laboratory studies in acute conjunctivitis. Arch Ophthalmol. 1982;100: Fitch CP, Rapoza PA, Owens S, et al. Epidemiology and diagnosis of acute conjunctivitis at an inner-city hospital. Ophthalmology. 1989;96: Rietveld RP, ter Riet G, Bindels PJE, et al. Predicting bacterial cause in infectious conjunctivitis: cohort study on informativeness of combinations of signs and symptoms. BMJ. 2004;329: Rietveld RP, vanweert CPM, ter Riet G, et al. Diagnostic impact of signs and symptoms in acute infectious conjunctivitis: systematic literature search. BMJ. 2003;327: Gigliotti F, Williams WT, Hayden FG, et al. Etiology of acute conjunctivitis in children. J Pediatrics. 1981;98(4): Solomon AS. Symptoms of allergic conjunctivitis. Arch Ophthalmol. 1985;103(7): Kosrirukvongs P, Visitsunthorn N, Vichyanond P, et al. Allergic conjunctivitis. Asian Pac J Allergy. 2001;19: Sambursky R, Tauber S, Schirra F, et al. The RPS Adeno Detector for diagnosing adenoviral conjunctivitis. Ophthalmology. 2006;113: Udeh BL, Schneider JE, Ohsfeldt RL. Cost effectiveness of a point-of-care test for adenoviral conjunctivitis. Am J Med Sci. 2008;336(3): Butt AL, Chodosh J. Adenoviral keratoconjunctivitis in a tertiary care eye clinic. Cornea. 2006;25(2): Hyde KJ, Berger ST. Epidemic keratoconjunctivitis and lacrimal excretory system obstruction. Ophthalmology. 1988;95(10): Hammer LH, Perry HD, Donnenfeld ED, et al. Symblepharon formation in epidemic keratoconjunctivitis. Cornea. 1990;9(4): Kaufman HE. Adenovirus advances: new diagnostic and therapeutic options. Curr Opin Ophthalmol. 2011;22: Gordon YJ, Gordon RY, Romanowski E, et al. Prolonged recovery of desiccated adenoviral serotypes 5, 8, and 19 from plastic and metal surfaces in vitro. Ophthalmology. 1993;100(12): American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. Conjunctivitis Limited Revision. San Francisco, CA: American Academy of Ophthalmology; Available at: Everitt H, Little P. How do GPs diagnose and manage acute infective conjunctivitis? A GP survey. Fam Pract. 2002;19(6): Matsui K, Shimizu H, Yoshida A, et al. Monitoring of adenovirus from conjunctival scrapings in Japan during J Med Virol. 2008;80: Woodland RM, Darougar S, Thaker U, et al. Causes of conjunctivitis and keratoconjunctivitis in Karachi, Pakistan. Royal Soc Tropical Medicine Hygiene. 1992;86(3): Sambursky RP, Fram N, Cohen EJ. The prevalence of adenoviral conjunctivitis at the Wills Eye Hospital emergency room. Optometry. 2007;78: AdenoPlus is a trademark of Rapid Pathogen Screening, Inc Nicox, Inc. All rights reserved.