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An evaluation study of the Becton-Dickinson ProbeTec Qx (BDQx) Trichomonas vaginalis trichomoniasis molecular diagnostic test in two large, urban STD services
  1. Craig Tipple1,2,
  2. Michael Rayment3,
  3. Sundhiya Mandalia3,
  4. Lisa Walton1,
  5. Sinead O'Neill1,
  6. John Murray1,
  7. Alan O'Riordan1,
  8. Monica Rebec1,
  9. Laura Harrington1,
  10. Rachael Jones3,
  11. Dawn Wilkinson1
  1. 1Imperial College Healthcare NHS Trust, London, UK
  2. 2GlaxoSmithKline Ltd, UK
  3. 3Chelsea and Westminster Hospital NHS Foundation Trust, London, UK
  1. Correspondence to Dr Craig Tipple, Imperial College Healthcare NHS Trust, London W2 1NY, UK; craig.tipple{at}imperial.nhs.uk

Abstract

Objectives The BASHH guidelines recommend molecular tests to aid diagnosis of Trichomonas vaginalis (TV) infection; however many clinics continue to use relatively insensitive techniques (pH, wet-prep microscopy (WPM) and culture). Our objectives were to establish a laboratory pathway for TV testing with the Becton-Dickinson Qx (BDQx) molecular assay, to determine TV prevalence and to identify variables associated with TV detection.

Methods A prospective study of 901 women attending two urban sexual health services for STI testing was conducted. Women were offered TV BDQx testing in addition to standard of care. Data collected were demographics, symptoms, results of near-patient tests and BDQx results for TV, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Women with any positive TV result were treated and followed up for test of cure (TOC).

Results 901 women had a TV BDQx test. 472 (53%) were white, 143 (16%) black and 499 (55%) were symptomatic. Infections detected by BDQx were: 11 TV (1.2%), three GC (0.3%) and 44 CT (4.9%). Of the 11 BDQx-detected TV infections, 8 (73%) were in patients of black ethnicity. Of these, four of seven cases (57%) were WPM-positive. All patients received treatment and nine of nine (100%) were BDQx-negative at TOC. In univariate analysis, only black ethnicity was associated with likelihood of a positive TV BDQx result (relative risk (RR) 10.2 (95% CI 2.15 to 48.4)).

Conclusions The use of the BDQ enhanced detection of TV in asymptomatic and symptomatic populations. Cost-effective implementation of the test will rely on further work to reliably detect demographic and clinical variables that predict positivity.

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Footnotes

  • Handling editor Jackie A Cassell

  • Twitter Follow Michael Rayment @mikeyrayment and Craig Tipple @craigtipple

  • Contributors CT and MRa conceived the study, wrote the protocol, obtained regulatory approval, analysed study data (in conjunction with SM) and wrote the first draft of the manuscript. LW and SO’N co-wrote the study protocol, recruited patients to the study and collected clinical data during the conduct of the study. They provided edits for the draft manuscript. LH collected trial data and contributed to the manuscript edits. LH collected trial data and contributed to the manuscript edits. MRe, AO’R and JM conducted the laboratory analyses for the study and wrote the laboratory aspects of the manuscript. DW and RJ were the principal investigators for the two study sites and approved the final draft of the manuscript.

  • Funding Tests were provided at a reduced rate for evaluation by Becton Dickinson Ltd (New Jersey, USA).

  • Competing interests None declared.

  • Ethics approval Bloomsbury Research Ethics Committee (REC) (ref: 15LO 0457).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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