8.5” 8.5”8.375”

1 misdiagnosisof conjunctivitis can put countless

EYES AT RISK

www.RPSdetectors.comRapid Pathogen Screening, Inc. • Executive Offices • 7227 Delainey Court • Sarasota, FL 34240 • Phone: 877-921-0080© 2009 RPS, Inc. All rights reserved. Spec 310 Rev 0 www.RPSdetectors.com

Professional Clinical Guidelines

AMERICAN ACADEMY OF OPHTHALMOLOGY Published the CONJUNCTIVITIS PREFERRED PRACTICE PATTERN in September 2008.

DIAGNOSTIC TESTS Most cases of conjunctivitis can be diagnosed on the basis of history and examination. However, in some cases additional diagnostic tests are helpful.

VIRAL DIAGNOSTIC TESTS Viral cultures are not routinely used to establish a diagnosis. A rapid, in-office immunodiagnostic test using antigen detection is available for adenovirus conjunctivitis. In a study of 186 patients with acute conjunctivitis, this test had a sensitivity of 88% to 89% and a specificity of 91% to 94%.[32] Immunodiagnostic tests may be available for other viruses, but these are not validated for ocular specimens. Polymerase chain reaction (PCR) may be used to detect viral deoxyribonucleic acid. Availability will vary depending on laboratory policy.

Reference 32: Sambursky R, Tauber S, Schirra F, et al. The RPS Adeno Detector for diagnosing adenoviral conjunctivitis. Ophthalmology 2006;113: 1758 – 64.

UpToDate.comAn official online educational program of, offered in cooperation with, or recommended by a number of major medical associations. Updated in September 2008.

DIAGNOSIS A rapid (10 minute) test for adenoviral conjunctivitis is now available. As discussed above, adenovirus is the major cause of viral conjunctivitis and likely accounts for a significant proportion of clinical encounters for conjunctivitis.

This test has reasonable sensitivity and specificity under study conditions [13], and might aid clinicians in determining a viral, as opposed to bacterial etiology, thereby avoiding empiric antibiotic therapy. Elimination of empiric antibiotic therapy has theoretical benefits including prescription drug savings, avoidance of side effects, and reduction of antibiotic resistance. A modeled cost effectiveness analysis suggests a potential for significant cost savings with point of care testing [14].

Reference 13. Sambursky, R, Tauber, S, Schirra, F, et al. The RPS Adeno Detector for Diagnosing Adenoviral Conjunctivitis. Ophthalmology 2006; 113:1758. Reference 14. Udeh, BL, Schneider, JE, Ohsfeldt, RL. Cost effectiveness of a point- of-care test for adenoviral conjunctivitis. Am J Med Sci 2008; 336:254.

AMERICAN COLLEGE OF PHYSICIANSPublished the PHYSICIANS INFORMATION AND EDUCATION RESOURCE (PIER) in 2006.

RATIONALE Although most conjunctivitis can be diagnosed on history and physical examination as infectious, the nature of the infectious agent, a virus or bacteria, is often difficult to determine. In-office testing for adenovirus may assist in establishing a correct diagnosis, but in some unusual cases and in patients unresponsive to treatment, special tests may be indicated.

EVIDENCE A prospective, masked clinical trial of a 10-minute in-office immunoassay for detecting adenovirus conjunctivitis showed a sensitivity of 89% and specificity of 94% compared to PCR, whereas viral cell culture showed a sensitivity of 91% and specificity of 100% (24).

Reference 24. [2] Sambursky R, Tauber S, Schirra F, Kozich K, Davidson R, Cohen EJ. The RPS Adeno Detector for diagnosing adenoviral conjunctivitis. Ophthalmology. 2006;113:1758-64. (PMID 17011956)

AMERICAN ACADEMY OF PEDIATRICSPublished the RED BOOK in July 2009.

DIAGNOSTIC TESTS The preferred methods for diagnosis of adenovirus infection include cell culture as well as antigen and DNA detection. Adenoviruses associated with respiratory tract disease can be isolated from pharyngeal and eye secretions and feces by inoculation of specimens into susceptible cell cultures. A pharyngeal or ocular isolate is more suggestive of recent infection than is a fecal isolate, which may indicate prolonged carriage or recent infection. Adenovirus antigens can be detected in less than 30 minutes in a variety of body fluids from infected people by commercial immunoassay techniques. These rapid assays especially are useful for diagnosis of diarrheal disease, because enteric adenovirus types 40 and 41 usually cannot be isolated in standard cell cultures, and for ocular disease.

RPS Adeno Detector™ The Only Rapid, In-OfficeDetector for Conjunctivitis

The RPS Adeno Detector gives you the information you need to diagnose and treat acute conjunctivitis – right in your office.

RPS Adeno Detector™

Right Diagnosis• Accurate, in-office test• Easy to use• Protect family members and others from the spread of disease

Right Treatment• Reduce antibiotic resistance• Reduce costs

Right Now• Results in just 10 minutes• Eliminates costly lab tests• Decide rapidly on the patient’s return to school or work

Technical SpecificationsClinical performance compared with PCR7:• Sensitivity: 89%• Specificity: 94%• Total Agreement: 92%

Intended Use:• The RPS Adeno Detector™ is a rapid immunochromatographic test for visual, qualitative in-vitro detection of adenoviral antigens (hexon protein) directly from human eye fluid. • The test is intended for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis.

Ordering Information• Part No.: RPS-AD RPS Adeno Detector Case of 20 Single Test Kits• Part No.: RPS-ADSTD Kit with [1] Positive & [1] Negative External Control Samples

Up to 65% of all conjunctivitis cases are viral.8

As many as 90% of these may be adenovirus.9

ReimbursedCPT 87809QW

CLIA-Waived

8. Marangon FB, Miller D, Alfonso E. Laboratory results in ocular viral diseases: implications in clinical-laboratory correlation. Arq Bras Oftalmol 2007;70:189-94 9. Infectious Agents Surveillance Center of Japan. Viruses isolated from the eye, Japan, 1990-1994. Infectious Agents Surveillance Report 1995;16:97-98

8.5” 8.5” 8.375”

VIRAL VS. BACTERIAL: ARE SIGNS AND SYMPTOMS ENOUGH?3,4,5

URIV:55%, B:5-8%

LymphadenopathyV:31%, B:6%

Watery DischargeV:50%, B:39% Follicles

V:47%, B:42%

Mucoid DischargeV:19%, B:17%

Purulent DischargeV:25-45%, B:28-93%

Bilateral InfectionV:35%, B:50-74%

VIRALCONJUNCTIVITIS

BACTERIALCONJUNCTIVITIS

The chart below shows just how much crossover there is for the known signs and symptoms of acute conjunctivitis.

3. O'Brien TP, Jeng BH, McDonald M, Raizman MB. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug;25(8):1953-61. 4. Fitch CP, Rapoza PA, Owens S, Murillo-Lopez F, Johnson RA, Quinn TC, Pepose JS, Taylor HR. Epidemiology and diagnosis of acute conjunctivitis at inner-city hospital. Ophthalmology. 1989;96:1215-20. 5. Gigliotti F, Williams WT, Hayden FG, Hendley JO. Etiology of acute conjunctivitis in children. J Pediatr 1981;98:531-6

You walk into an examining room and there sits your patient, red-eyed and suffering. You read the chart, probe for more information, and recognize that it’s an acute case of conjunctivitis.

But is it viral or is it bacterial?

Your training might lead you to believe that it’s an easy diagnosis to make. Bilateral infection, watery discharge, and upper respiratory complications

clearly point you to viral infection. Unilateral infection, purulent discharge and the absence of follicles clearly mean bacterial infection. Right?

The most current research says the diagnosis might not be as clear-cut as you think.2

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Pink eye affects six million people a year.1

Studies say nearly half are misdiagnosed.3

1. Thomson Reuters Medstat Marketscan Data, 2005 2. Rietveld RP, van Weert HC, ter Riet G, Bindels PJ.: Diagnostic impact of signs and symptoms in acute infectious conjunctivitis: systematic literature search. BMJ 2003;327:789.

The Right Diagnosis Leads to the Right Treatment … Right Now

“… a sensitive and specific rapid POC immunoassay could revolutionize the ability to provide immediate triage. Once the diagnosis is confirmed, appropriate management and treatment can be initiated.”3Managing infectious patients is critical for

preventing the spread of infection. When you know who needs isolation, you can act quickly to protect

the patients – and all of those who surround them. The table below offers an effective process for management of infected patients.

• Education: Hygiene and hand washing

• Consider topical antibiotics or other treatments

• Supportive care: Artificial tears, cool compress, topical antihistamines

• No antibiotics

CONJUNCTIVITIS

History • Symptoms • Signs

• “Pink eye” exposure, spread from one eye to the other, recent URI symptoms• Itching, burning, FBS, tearing, discharge, eye lash matting• Pre-auricular adenopathy, chemosis

RPS ADENO DETECTORTM

POSITIVE? NEGATIVE?

CONJUNCTIVITIS MANAGEMENT

7. Sambursky R, Tauber S, Schirra F, et al. The RPS adeno detector for diagnosing adenoviral conjunctivitis. Ophthalmology. 2006;113):1758-64.

7

When patients come to you, they expect you to do something … something that will make them feel better. Studies have demonstrated that 95% of health care professionals6 automatically prescribe an antibiotic for a diagnosis of conjunctivitis – no matter whether it is viral or bacterial.

Most education and employee health policies state that a diagnosed pink eye patient can return to school or work 24-48 hours after beginning antibiotic therapy. The problem is antibiotics are ineffective in treating the viral form of the infection. When these patients return to the classroom or the office too soon, they expose all those around them.

The Wrong Treatment Creates Risk for Others

“The exact duration of infectivity associated with adenoviral conjunctivitis is uncertain. Studies demonstrate that positive cultures could be obtained from 5-10% of the eyes of patients with adenoviral conjunctivitis at 14-16 days. Other studies demonstrate that the virus remains in an active or infectious state on hard surfaces for up to 4-5 weeks. The transmission rate to close contacts or family members has been shown to be 10-50% depending on the serotype”3

6. Everitt H, Little P. How do GP’s diagnose and manage acute infective conjunctivitis? A GP survey. Fam Pract. 2002;19:658-60.

““…adenovirus is known to cause considerable morbidity. Once the cornea becomes involved, and subepithelial infiltrates develop, it can be months or even years of poor vision, discomfort, and may necessitate the need for corticosteroids with all the attendant complications of chronic corticosteroid use. In other circumstances, pseudomembrane formation may lead to significant conjunctival scarring with loss of goblet cells and symblepharon formation, and may result in persistent or permanent dry eyes, and the need for chronic tear supplementation”3

INCREASED EXPOSURE TRANSLATES INTO INCREASED MORBIDITY RATES. Acute viral conjunctivitis is not a benign condition.