Technical Bulletin

Allergic Eye Test Kit

Currently: For Investigational Use Only

Intended Use: The SolAurum Allergic Eye Test is a rapid and simple in vitro diagnostic device to measure basal tear IgE in the assessment of allergic involvement as an aid in the diagnosis of allergic conjunctivitis.

Medical Background: Allergic conjunctivitis is the eye's reaction to allergy-causing substances (allergens) like pollen and dander. Allergic reactions cause unhealthy localized inflammatory responses around the ocular surface. This can lead to giant papillary conjunctivitis (GPC) in contact lens wearers, or produce diffuse lamellar keratitis (DLK) following LASIK surgery.

Diagnosing allergic conjunctivitis is very subjective and is usually based on physical examination and the patient's signs and symptoms. Since immunoglobulin E (IgE), from the conjunctival plasma cells, is the primary responder in allergic conjunctivitis, testing tears for elevated IgE is a simple and objective way to test for localized allergic conjunctivitis. This assay is simple to perform and very specific.

Successful LASIK surgery is highly correlated with the optimal selection of the surgical candidate and the appropriate pre-operative preparation of the eyes. Patients with ocular surface disorders are usually highly motivated to undergo refractive surgery because of their difficulty in wearing contact lenses. Ocular surface disorders, including allergic conjunctivitis, can lead to an inaccurate pre-operative assessment and alter surgical results. Pre-operative diagnoses and treatment of dry eye and allergic conjunctivitis reduces the potential for poor outcomes and maximizes patient satisfaction.

A distinct syndrome called ‘diffuse lamellar keratitis’ (DLK) has been described involving noninfectious diffuse infiltrates in the lamellar interface following LASIK surgery. Although the infiltrates are sterile, the cornea attacks them and, if left unchecked, will destroy itself, causing epithelial irregularity, corneal melting, and permanent reduction in visual acuity. It is imperative that the surgeon correctly differentiates DLK from an infectious infiltrate, and then manages the syndrome expeditiously to ensure that the patient has a positive prognosis. The cause of DLK had remained an enigma until Boorstein, et al, in the January 2003 Journal of Ophthalmology, reported that allergies was a patient-specific risk factor for developing DLK following LASIK.

Benefits of the SolAurum Dry Eye Test:

• Clinically relevant
• Simple to perform
• Inexpensive
• Reliable
• Reimbursable
• CLIA waived
• Cost effective
• Accurate

Diagnostic Analyte: IgE >80 ng/ml

Kit Components:

• 10 Rapid Cassettes
• Chase solution

Test Procedure:

1. Using capillary action, collect 0.5 ul of tears with a precision micro-capillary tube
2. Dispense sample to the small red sample membrane on an IgE test cassette
3. Add 3 drops of chase solution to the larger white membrane port
4. Allow the assay to react for 5 minutes
5. Examine the membrane for a positive reaction at the test line
6. Ensure that the control line is reactive to certify validity

Interpretation of Results:

• Allergic Eye Patient has >80 ng/ml of basal tear IgE when Test Line is Reactive (with valid Control Line)
• Non-allergic Patient has <80 ng/ml of basal tear IgE when Test Line is Negative (with valid Control Line)
• Invalid test: Whenever the Control Line does not develop

The SolAurum Advantage:

• Simple and inexpensive diagnostic platform
• No capital equipment required
• No burdensome regulatory requirements
• Proven medical utility
• Focus on product quality and customer satisfaction

Reimbursement: Upon FDA approval, the SolAurum Dry Eye Test qualifies for 3^rd party reimbursement under CPT code: 82785

info@solaurum.com

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