Tech Bulletin

Technical Bulletin

SolAurum Tear Protein Test
for Dry Eye

Intended Use: The SolAurum Dry Eye Test is a rapid and simple in vitro diagnostic device to assess lacrimal gland function in the diagnosis of aqueous deficient dry eye.

Medical Background: Protein sufficient tears are critical to maintain proper eye health. Tear proteins provide the same function for the cornea that blood provides for the body. Since the cornea must be a clear window to see through, it cannot contain blood vessels. Since there is no blood source, the tear film must deliver to the ocular surface all of the necessary components essential for proper maintenance. Cells in the conjunctiva produce some constituents of the tear film; however, the acinar cells in the lacrimal glands produce most. The primary and auxiliary lacrimal glands are lined with these secretory cells that generate the numerous biochemicals the cornea must have for the following:

Growth factors for cellular development and wound healing
Anti-microbial proteins for infection protection
Bio-resources for anti-inflammatory regulation
Nutrition for corneal metabolism
Moisture for crucial hydration
Oxygen for cellular respiration

Analyzing this vital fluid is a valuable and objective tool in assessing the health of the corneal surface. Ophthalmic physicians often rely on treatments based solely on the signs and symptoms presented by their patients. This may result in more than one office visit to diagnose disease, as many problems present with similar signs and symptoms.

Dry Eye Syndrome is a persistent dryness of the cornea and conjunctiva due to decreased function of the tear glands or increased evaporation of tears. This may be caused by neurologic unresponsiveness on the ocular surface, corneal inflammation, lacrimal degeneration, Sjögren’s syndrome, or a medicinal side effect. The decrease in acinar cell function leads to dry eye syndrome and other disease entities. Lactoferrin is an ideal marker for assessing secretory function of the acinar cells since these cells in the lacrimal glands produce it. These secretory cells produce most of the important constituents in tears. By measuring lactoferrin in tear fluid, it is possible to evaluate the functionality of the acinar cells and thereby assess tear film vitality.

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 aqueous tear deficiency, can lead to an inaccurate pre-operative assessment and alter surgical results. Pre-operative diagnoses and treatment of dry eye reduces the potential for poor outcomes and maximizes patient satisfaction.

Benefits of the SolAurum Dry Eye Test:

Clinically relevant
Simple to perform
Inexpensive
Reliable

Reimbursable
Cost effective
Accurate

Diagnostic Analyte:

Disease	Analyte
Aqueous deficient dry eye à	Lactoferrin <0.9 mg/ml

Kit Components:

15 Rapid Cassettes
Chase solution
Package Insert

Test Procedure:

Extract 0.5 ul of tears using a micro-capillary
Add the sample to a test cassette
Add 4 drops of chase solution to the cassette
Allow the assay to react for 5 minutes
Examine the membrane for a positive reaction at the test line
Ensure the control line is reactive to certify validity

Interpretation of Results:

Aqueous Deficient Dry Eye: Patient has <0.9 mg/ml tear lactoferrin	Control Line DARKER than the Test Line
Aqueous Normal Dry Eye: Patient has >0.9 mg/ml tear lactoferrin	Test Line DARKER than the Control Line
Invalid test:	Whenever no lines 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: The SolAurum Dry Eye Test will soon qualify for 3^rd party reimbursement under CPT code 83520.