title: A new rapid molecular point-of-care assay for Trichomonas vaginalis: preliminary performance data.
abstract: OBJECTIVE
  Trichomonas vaginalis infection is the most prevalent treatable sexually transmitted infection (STI) in the world. An accurate point-of-care (PoC) molecular test would enable patients to be tested and treated for T vaginalis in a single visit to the genitourinary medicine clinic, community STI clinic, pharmacy or doctor's office. In this report, we describe a rapid prototype assay for T vaginalis designed for use in conjunction with the Atlas io PoC platform, and initial verification of its performance using 90 clinical samples.
  
  
  METHODS
  A rapid prototype T vaginalis assay was designed. The test, featuring novel electrochemical end-point detection, used a multi-copy region of the T vaginalis genome as the assay target. Ninety clinical vaginal swab samples were used to verify the performance of the prototype assay.
  
  
  RESULTS
  The assay demonstrated a sensitivity and specificity of 95.5% (42/44) and 95.7% (44/46), respectively, when tested using clinical samples. Assay inclusivity was demonstrated for a number of geographically diverse T vaginalis isolates, and the test showed no cross-reactivity with either human DNA or a panel of DNAs isolated from common cross-reactants.
  
  
  CONCLUSIONS
  The sensitivity and specificity achieved using this prototype assay is comparable with that achieved for existing central laboratory nucleic acid amplification tests used for screening patients for T vaginalis.
authors.affiliation: Atlas Genetics, Trowbridge, Wiltshire, UK. david.pearce@atlasgenetics.com
authors.forename: David M
authors.initials: DM
authors.lastname: Pearce
authors.forename: David N
authors.initials: DN
authors.lastname: Styles
authors.forename: Justin P
authors.initials: JP
authors.lastname: Hardick
authors.forename: Charlotte A
authors.initials: CA
authors.lastname: Gaydos
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D010274:Parasitology / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D014245:Trichomonas Infections / Q000175:diagnosis* / Q000469:parasitology; D014246:Trichomonas vaginalis / Q000302:isolation & purification*
keywords: DIAGNOSIS; DNA AMPLIFICATION; TRICHOMONAS