Transcript Title of article

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.
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Introduction
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A study was conducted to determine the clinical sensitivity, specificity,
negative predictive value, and positive predictive value of a rapid point-ofcare diagnostic test to detect elevated matrix metalloproteinase 9 (MMP-9)
levels (InflammaDry).
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MMP-9 is an inflammatory biomarker that has been shown to be elevated
in the tears of patients with dry eyes.
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The ability to accurately detect elevated MMP-9 levels may lead to earlier
diagnosis, more appropriate treatment, and better management of ocular
surface disease.
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Methods
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Study Design: Prospective, sequential, masked, multicenter clinical trial.
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InflammaDry was performed on 206 patients.
– 143 with clinical signs and symptoms of dry eyes and 63 healthy
control subjects.
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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.
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The sensitivity and specificity of the InflammaDry test were compared with
clinical assessment.
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Methods
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Results
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Compared with clinical assessment, the InflammaDry test is sensitive and
specific at diagnosing dry eye.
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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).
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Results
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Comment
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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.
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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.
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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.
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Comment
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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.
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It is postulated that patients with positive test results with InflammaDry may
benefit from initial intervention with anti-inflammatory therapy.
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The ability to accurately detect elevated MMP-9 levels may lead to earlier
diagnosis, more appropriate treatment, and better management of ocular
surface disease.
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Contact Information
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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
([email protected]).
Conflict of Interest Disclosures
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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
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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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