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A new rapid molecular point-of-care assay for Trichomonas vaginalis: preliminary performance data
  1. David M Pearce1,
  2. David N Styles1,
  3. Justin P Hardick2,
  4. Charlotte A Gaydos2
  1. 1Atlas Genetics, Trowbridge, Wiltshire, UK
  2. 2Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Dr David M Pearce, Atlas Genetics, Derby Court, White Horse Business Park, Trowbridge, Wiltshire BA14 0XG, UK; david.pearce{at}atlasgenetics.com

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.

  • TRICHOMONAS
  • DIAGNOSIS
  • DNA AMPLIFICATION

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