title: Performance of the OSOM Trichomonas Rapid Test for diagnosis of Trichomonas vaginalis infection among women in Mysore, India.
abstract: Background Trichomonas vaginalis is the world's most common treatable sexually transmissible infection. Currently, wet mount microscopy and syndromic management based on vaginal discharge are the most widely used methods for diagnosing and treating trichomoniasis in resource-constrained settings. Wet mount microscopy requires equipment and trained technicians, who are in short supply. We examined the diagnostic accuracy of the OSOM Trichomonas Rapid Test for detecting T. vaginalis vaginal infection among women in Mysore, India.
  
  
  METHODS
  During July 2009-August 2010, 450 sexually active women over 18 years seeking care at an urban reproductive health clinic were enrolled in the study. Clinician-collected vaginal swabs were evaluated for trichomonads using wet mount microscopy, InPouch culture and the OSOM test.
  
  
  RESULTS
  Of the 418 samples included in the analyses, culture detected 68 (16.3%) positive samples, wet mount microscopy detected 56 of the culture-positive samples and four false positive samples. The OSOM test detected 60 of the culture-positive samples plus two false positive cases. Using the composite reference standard (CRS), defined as wet mount- or culture-positive, the sensitivities of wet mount, the OSOM test and culture were 83.3%, 86.1% and 94.4%, respectively. The positive and negative predictive values of the OSOM test were 100% and 97.1% respectively. The Cohen's kappa agreement between the OSOM test and the CRS was excellent (κ=0.94).
  
  
  CONCLUSIONS
  The OSOM test has high sensitivity, excellent specificity, and excellent positive and negative predictive value compared to a CRS. This simple test can improve screening and diagnosis of T. vaginalis infection in resource-constrained settings where microscopy and culture are unavailable.
authors.affiliation: Department of Epidemiology, Robert Stempel College of Public Health & Social Work, 11200 SW 8 Street, HLS 390W2, Miami, FL 33199, USA.
authors.forename: Purnima
authors.initials: P
authors.lastname: Madhivanan
authors.forename: Tan
authors.initials: T
authors.lastname: Li
authors.forename: Stephanie
authors.initials: S
authors.lastname: Trammell
authors.forename: Chirayu
authors.initials: C
authors.lastname: Desai
authors.forename: Vijaya
authors.initials: V
authors.lastname: Srinivas
authors.forename: Anjali
authors.initials: A
authors.lastname: Arun
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Klausner
authors.forename: Karl
authors.initials: K
authors.lastname: Krupp
mesh_terms: D005260:Female; D006801:Humans; D012680:Sensitivity and Specificity; D014244:Trichomonas; D014245:Trichomonas Infections; D014247:Trichomonas Vaginitis / Q000175:diagnosis; D014246:Trichomonas vaginalis