A preliminary evaluation of a new GeneXpert (Gx) molecular point-of-care test for the detection of Trichomonas vaginalis

S G Badman, L M Causer, R Guy, S N Tabrizi, F Francis, Basil Donovan, D Whiley, TANGO investigators, John Kaldor, David Wilson, David Regan, Handan Wand, Mark Shephard, James Ward, Kit Fairley, Belinda Hengel, Annie Tangey, David Anderson, Lisa Natoli

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    Abstract

    Objectives Global concerns regarding the prevalence, asymptomatic nature and burden of disease associated with Trichomonas vaginalis (TV) continue. The lack of a portable molecular point-of-care assay to detect this infectious disease has meant that many remote or low-resource settings still need to rely on delayed results from central laboratories and/or syndromic management as treatment strategies. We evaluated the new GeneXpert (Gx) TV nucleic acid amplification test (NAAT) compared with an in-house laboratory NAAT to determine whether it would be suitable for use at the point of care. Methods In a state-based laboratory and using their in-house NAAT, we selected the first 60 urine samples that were positive and the first 60 that were negative (n=120) in the study period for Gx TV testing in order to reduce collection delays and avoid the freezing of samples. Results Positive percentage agreement between the Gx TV and NAAT was 95.0% (95% CI 86.1% to 99.0%), negative percentage agreement was 100.0% (95% CI 93.5% to 100.0%) and overall percentage agreement was 97.4% (95% CI 92.5% to 99.5%). Three discordant results were detected with each being close to the cycle threshold of detection using the in-house NAAT assay. Conclusions Findings suggest the Gx TV assay is easy to use and has suitable overall agreement for sexually transmissible infection (STI) testing at the point of care. It may be used in combination with the Gx CT/NG assay to test for all three STIs simultaneously using this portable and modular-based NAAT platform.

    Original languageEnglish
    Pages (from-to)350-352
    Number of pages3
    JournalSexually Transmitted Infections
    Volume92
    Issue number5
    DOIs
    Publication statusPublished - Aug 2016

    Keywords

    • Trichomonas vaginalis
    • point-of-care test
    • GeneXpert (Gx)
    • nucleic acid amplification test
    • NAAT
    • exuallytransmissible infection

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  • Cite this

    Badman, S. G., Causer, L. M., Guy, R., Tabrizi, S. N., Francis, F., Donovan, B., Whiley, D., TANGO investigators, Kaldor, J., Wilson, D., Regan, D., Wand, H., Shephard, M., Ward, J., Fairley, K., Hengel, B., Tangey, A., Anderson, D., & Natoli, L. (2016). A preliminary evaluation of a new GeneXpert (Gx) molecular point-of-care test for the detection of Trichomonas vaginalis. Sexually Transmitted Infections, 92(5), 350-352. https://doi.org/10.1136/sextrans-2015-052384