A new rapid molecular point-of-care assay for Trichomonas vaginalis: Preliminary performance data

David M. Pearce, David N. Styles, Justin P. Hardick, Charlotte A. Gaydos

Research output: Contribution to journalArticlepeer-review

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 endpoint 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.

Original languageEnglish (US)
Pages (from-to)495-497
Number of pages3
JournalSexually transmitted infections
Volume89
Issue number6
DOIs
StatePublished - Sep 2013

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

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