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Introduction

Sensitivity and Specificity of a Point-of-Care Matrix Metalloproteinase 9 Immunoassay for Diagnosing Inflammation Related to Dry Eye.

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Introduction

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  1. 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. 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. Methods • 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.

  4. Methods

  5. Results • 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).

  6. Results

  7. Comment • 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 al1 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.

  8. Comment • 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.

  9. Contact Information • 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.

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