title: Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye.
abstract: OBJECTIVE
  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 levels (InflammaDry).
  
  
  METHODS
  In a prospective, sequential, masked, multicenter clinical trial, InflammaDry was performed on 206 patients: 143 patients with clinical signs and symptoms of dysfunctional tear syndrome (dry eyes) and 63 healthy individuals serving as controls. Participants were assessed as healthy controls or for a clinical diagnosis of dry eye using the Ocular Surface Disease Index, Schirmer tear test, tear breakup time, and keratoconjunctival staining.
  
  
  METHODS
  The sensitivity and specificity of InflammaDry were compared with clinical assessment.
  
  
  RESULTS
  InflammaDry showed sensitivity of 85% (in 121 of 143 patients), specificity of 94% (59 of 63), negative predictive value of 73% (59 of 81), and positive predictive value of 97% (121 of 125).
  
  
  CONCLUSIONS
  Compared with clinical assessment, InflammaDry is sensitive and specific in diagnosing dry eye.
  
  
  CONCLUSIONS
  Dry eye is often underdiagnosed resulting from poor communication between the clinical assessment of dry eye severity between clinicians and patients. This often leads to a lack of effective treatment. Matrix metalloproteinase 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 matrix metalloproteinase 9 levels may lead to earlier diagnosis, more appropriate treatment, and better management of ocular surface disease. Preoperative and perioperative management of inflammation related to dry eyes may reduce dry eyes that develop after laser in situ keratomileusis, improve wound healing, and reduce flap complications. Recognition of inflammation may allow for targeted perioperative therapeutic management of care for patients who undergo cataract and refractive surgery and improve outcomes.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01313351.
authors.affiliation: Manatee Sarasota Eye Clinic and Laser Center, Sarasota, Bradenton, FL 34202, USA. robsambo@yahoo.com
authors.forename: Robert
authors.initials: R
authors.lastname: Sambursky
authors.forename: William F
authors.initials: WF
authors.lastname: Davitt
authors.forename: Robert
authors.initials: R
authors.lastname: Latkany
authors.forename: Shachar
authors.initials: S
authors.lastname: Tauber
authors.forename: Christopher
authors.initials: C
authors.lastname: Starr
authors.forename: Murray
authors.initials: M
authors.lastname: Friedberg
authors.forename: Monte S
authors.initials: MS
authors.lastname: Dirks
authors.forename: Marguerite
authors.initials: M
authors.lastname: McDonald
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003228:Conjunctiva / Q000378:metabolism; D003315:Cornea / Q000378:metabolism; D004311:Double-Blind Method; D005189:False Positive Reactions; D005260:Female; D019793:Fluorescein / Q000378:metabolism; D015590:Fluorophotometry; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007638:Keratoconjunctivitis Sicca / Q000175:diagnosis* / Q000201:enzymology; D008297:Male; D020780:Matrix Metalloproteinase 9 / Q000378:metabolism*; D008875:Middle Aged; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D012859:Sjogren's Syndrome / Q000175:diagnosis* / Q000201:enzymology; D013666:Tears / Q000737:chemistry / Q000201:enzymology*; D055815:Young Adult
chemical_list: D020780:Matrix Metalloproteinase 9; D019793:Fluorescein