2014
DOI: 10.1097/ico.0000000000000175
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Prospective, Multicenter, Clinical Evaluation of Point-of-Care Matrix Metalloproteinase-9 Test for Confirming Dry Eye Disease

Abstract: The InflammaDry test demonstrates a high positive and negative agreement for confirming suspected dry eye disease. In addition, the test was safely and effectively performed by untrained operators. These findings support the intended use of the InflammaDry test as an aid in the diagnosis of dry eye.

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Cited by 86 publications
(76 citation statements)
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“…Standard testing revealed a sensitivity of 86% and specificity of 97% using combined diagnostic criteria of dry-eye tests (OSDI > = 13, Schirmer II < 10 mm, TBUT < 10 s, and staining > = 1).There was also a good correlation of MMP-9 expression with the different severity levels of the dry-eye condition (DEWS severity criteria) (82). More recently, Schargus et al have evaluated the performance of MMP-9 using InflammaDry (and confirmed by ELISA) and tear film osmolarity (TFO) tests in a cohort of 20 elderly patients with potential dry-eye disease, finding a positive association only between MMP-9 and corneal staining.…”
Section: Accepted Manuscriptmentioning
confidence: 79%
“…Standard testing revealed a sensitivity of 86% and specificity of 97% using combined diagnostic criteria of dry-eye tests (OSDI > = 13, Schirmer II < 10 mm, TBUT < 10 s, and staining > = 1).There was also a good correlation of MMP-9 expression with the different severity levels of the dry-eye condition (DEWS severity criteria) (82). More recently, Schargus et al have evaluated the performance of MMP-9 using InflammaDry (and confirmed by ELISA) and tear film osmolarity (TFO) tests in a cohort of 20 elderly patients with potential dry-eye disease, finding a positive association only between MMP-9 and corneal staining.…”
Section: Accepted Manuscriptmentioning
confidence: 79%
“…Using a point-of-care lateral flow immunoassay (InflammaDry ® ; Rapid Pathogen Screening, Sarasota, FL, USA), which detects both pro-and active MMP-9 at tear concentrations ≥40 ng/mL, elevated tear MMP-9 was found to have high sensitivity and specificity with clinical diagnosis of dry eye in two studies, and in another study, a positive result was significantly correlated with severity of irritation symptoms and ocular surface dye staining, tear break-up time and systemic autoimmune disease, particularly SS. [67][68][69] Using the same assay, Lanza et al found only 39% of subjects with symptoms of dry eye had a positive MMP-9 assay and there was no difference in the profile of signs and symptoms between MMP-9-positive and …”
Section: Correlations Between Mmp-9 and Severitymentioning
confidence: 99%
“…Indeed, MMP-9 has been proposed as a marker for severe dry eye 21. Although the InflammaDry test demonstrated a high positive and negative agreement for confirming suspected dry eye disease,22 none of the previous studies have evaluated the performance of InflammaDry in post-LASIK dry eyes. Indeed, not all cases with dry eyes are associated with significant inflammation.…”
Section: Discussionmentioning
confidence: 99%
“…Indeed, not all cases with dry eyes are associated with significant inflammation. Sambursky et al 22 examined only symptomatic patients and showed that 61% of symptomatic patients by OSDI actually had a positive confirmatory test using Schirmer test, TBUT or staining, and 81% of those patients with any positive confirmatory test showed elevated MMP-9. The primary utility for InflammaDry should not be simply as a diagnostic tool for dry eye but a tool for the presence of inflammation related to dry eye.…”
Section: Discussionmentioning
confidence: 99%