1. Copyright restrictions may apply Sensitivity and Specificity of a Point-of-Care Matrix Metalloproteinase 9 Immunoassay for Diagnosing Inflammation Related to Dry Eye Sambursky R, Davitt WF III, Latkany R, et al. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013;131(1):24-28.

2. Copyright restrictions may apply Introduction A study was conducted to determine the clinical sensitivity, specificity, negative predictive value, and positive predictive value of a rapid point-of- care diagnostic test to detect elevated matrix metalloproteinase 9 (MMP-9) levels (InflammaDry). MMP-9 is an inflammatory biomarker that has been shown to be elevated in the tears of patients with dry eyes. The ability to accurately detect elevated MMP-9 levels may lead to earlier diagnosis, more appropriate treatment, and better management of ocular surface disease.

3. Copyright restrictions may apply Study Design: Prospective, sequential, masked, multicenter clinical trial. InflammaDry was performed on 206 patients. –143 with clinical signs and symptoms of dry eyes and 63 healthy control subjects. Patients were assessed as healthy control subjects or for a clinical diagnosis of dry eye using the Ocular Surface Disease Index, Schirmer tear test, tear breakup time, and keratoconjunctival staining. The sensitivity and specificity of the InflammaDry test were compared with clinical assessment. Methods

4. Copyright restrictions may apply Methods

5. Copyright restrictions may apply Compared with clinical assessment, the InflammaDry test is sensitive and specific at diagnosing dry eye. InflammaDry showed a sensitivity of 85% (121 of 143 patients), a specificity of 94% (59 of 63 patients), a negative predictive value of 73% (59 of 81 patients), and a positive predictive value of 97% (121 of 125 patients). Results

6. Copyright restrictions may apply Results

7. Copyright restrictions may apply Dry eye is often underdiagnosed owing to the disconnect between the clinical assessment of dry eye severity by clinicians and patients. This often leads to a lack of effective treatment. Chronic dry eye syndrome was characterized in the 2007 Report of the Dry Eye Workshop into levels of severity based on the presence or absence of a combination of symptoms and signs. Chotikavanich et al 1 showed that MMP-9 activity increases proportionally along with increasing severity of dry eye syndrome, elevated levels of MMP-9 correlate with clinical examination findings, and MMP-9 may be a more sensitive marker than clinical signs. 1 Chotikavanich S, De Paiva CS, Li Q, et al. Production and activity of matrix metalloproteinase-9 on the ocular surface increase in dysfunctional tear syndrome. Invest Ophthalmol Vis Sci. 2009;50(7):3203-3209. Comment

8. Copyright restrictions may apply Reducing ocular inflammation is the target for many dry eye therapeutics. –Topical cyclosporine treatment inhibits T-lymphocyte proliferation and decreases the levels of MMP-9 expression in conjunctival epithelial cells. –Corticosteroids inhibit inflammation and decrease the production of inflammatory cytokines and MMP-9 by the corneal epithelium. –Doxycycline preserves the tight junction network, increases corneal smoothness, preserves corneal barrier function, and leads to a reduction in the production and activity of MMP-9. It is postulated that patients with positive test results with InflammaDry may benefit from initial intervention with anti-inflammatory therapy. The ability to accurately detect elevated MMP-9 levels may lead to earlier diagnosis, more appropriate treatment, and better management of ocular surface disease. Comment

9. Copyright restrictions may apply If you have questions, please contact the corresponding author: –Robert Sambursky, MD, Manatee Sarasota Eye Clinic and Laser Center, 13946 Wood Duck Cir, Bradenton, FL 34202 (robsambo@yahoo.com). Conflict of Interest Disclosures Dr Sambursky has an affiliation with Rapid Pathogen Screening, Inc; however, none of the principal investigators have any financial interest in InflammaDry or in Rapid Pathogen Screening, Inc. Funding/Support The design and conduct of the study and the collection of data described in the article were sponsored by Rapid Pathogen Screening, Inc. Contact Information