title: Evaluation of a novel point-of-care test for active matrix metalloproteinase-8: agreement between qualitative and quantitative measurements and relation to periodontal inflammation.
abstract: OBJECTIVE
  Severe periodontitis affects about 10% of the world population. In addition, associations between periodontitis and systemic diseases exist. Therefore, the diagnosis should be made quickly and at an early stage. Matrix metalloproteinase-8 (MMP-8) is the most prominent collagenase found in inflamed periodontal tissues. Its active form (aMMP-8) is increasingly used as a diagnostic biomarker. Aim of the present study is to evaluate the diagnostic accuracy of a novel aMMP-8 point-of-care (POC) test in comparison to the standard laboratory test to diagnose the disease rapidly and reliably.
  
  
  METHODS
  In a prospective, mono-center, double-blinded, case-control study, participants with healthy gums (n = 35), gingivitis (n = 60) and periodontitis (n = 35) were investigated before and after therapy. Beside clinical variables for plaque and inflammation, aMMP-8 concentrations were determined in oral rinsing specimens by the enzyme-linked immunosorbent assay (ELISA) and by POC. Positive and negative percent agreements with their exact one-sided lower 95% confidence limits were calculated.
  
  
  RESULTS
  Of 130 participants, 111 finished the study. Overall, positive percent agreements were 75.8% (57.7-88.9) before treatment and 73.7% (56.9-86.6) after treatment. Negative percent agreements were 92.8% (85.7-97.0) before and 93.3% (85.1-97.8) after treatment. Positive test results (POC and ELISA) ranged from 5.7% to 8.6% in healthy patients, 25.0-29.8% in patients with gingivitis and 40.0-48.1% in patients with periodontitis. Patients who had positive aMMP-8 test results (POC) showed higher scores for plaque and inflammation.
  
  
  CONCLUSIONS
  The novel POC test to detect aMMP-8 has proved to agree strongly with the standard method, ELISA. The test can be recommended to screen patients at risk for periodontitis in dental offices, at the general practitioner and at specialists for associated diseases.
authors.affiliation: Department of Periodontology, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Lorenz
authors.affiliation: ACOMED statistik, Leipzig, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Keller
authors.affiliation: Department of Periodontology, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Noack
authors.affiliation: Department of Periodontology, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Freitag
authors.affiliation: Department of Periodontology, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Netuschil
authors.affiliation: Department of Periodontology, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Hoffmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005891:Gingivitis / Q000175:diagnosis* / Q000201:enzymology; D006801:Humans; D008297:Male; D020784:Matrix Metalloproteinase 8 / Q000032:analysis*; D008875:Middle Aged; D010518:Periodontitis / Q000175:diagnosis* / Q000201:enzymology; D000067716:Point-of-Care Testing; D011446:Prospective Studies; D015203:Reproducibility of Results; D012463:Saliva / Q000201:enzymology; D055815:Young Adult
chemical_list: D020784:Matrix Metalloproteinase 8
keywords: clinical study; diagnostic accuracy; matrix metalloproteinase; periodontal diagnostics; point-of-care testing