Performance of self-collected penile-meatal swabs compared to clinician-collected urethral swabs for the detection of Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , and Mycoplasma genitalium by nucleic acid amplification assays

Dize, Laura; Barnes, Perry; Barnes, Mathilda; Hsieh, Yu Hsiang; Marsiglia, Vincent C.; Duncan, D; Hardick, Justin; Gaydos, Charlotte A.

doi:10.1016/j.diagmicrobio.2016.07.018

Cited by 39 publications

(31 citation statements)

References 20 publications

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“…Future studies should utilise collection of appropriate urethral specimens. Self-collected penile-meatal swabs have been shown to be acceptable for STI testing[ 79 ] and would facilitate self-sampling of the urethral microbiota at home.…”

Section: Discussionmentioning

confidence: 99%

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study

et al. 2018

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ObjectivesRecurrence following recommended treatment for bacterial vaginosis is unacceptably high. While the pathogenesis of recurrence is not well understood, recent evidence indicates re-infection from sexual partners is likely to play a role. The aim of this study was to assess the acceptability and tolerability of topical and oral antimicrobial therapy in male partners of women with bacterial vaginosis (BV), and to investigate the impact of dual-partner treatment on the vaginal and penile microbiota.MethodsWomen with symptomatic BV (Nugent Score of 4–10 and ≥3 Amsel criteria) and their regular male sexual partner were recruited from Melbourne Sexual Health Centre, Melbourne, Australia. Women received oral metronidazole 400mg twice daily (or intra-vaginal 2% clindamycin cream, if contraindicated) for 7-days. Male partners received oral metronidazole 400mg twice daily and 2% clindamycin cream topically to the penile skin twice daily for 7-days. Couples provided self-collected genital specimens and completed questionnaires at enrolment and then weekly for 4-weeks. Genital microbiota composition was determined by 16S rRNA gene sequencing. Changes in genital microbiota composition were assessed by Bray-Curtis index. Bacterial diversity was measured by the Shannon Diversity Index.ResultsTwenty-two couples were recruited. Sixteen couples (76%) completed all study procedures. Adherence was high; most participants took >90% of prescribed medication. Medication, and particularly topical clindamycin in males, was well tolerated. Dual-partner treatment had an immediate and sustained effect on the composition of vaginal microbiota (median Bray-Curtis score day 0 versus day 8 = 0.03 [IQR 0–0.15], day 0 vs day 28 = 0.03 [0.02–0.11]). We observed a reduction in bacterial diversity of the vaginal microbiota and a decrease in the prevalence and abundance of BV-associated bacteria following treatment. Treatment had an immediate effect on the composition of the cutaneous penile microbiota (median Bray-Curtis score day 0 vs day 8 = 0.09 [0.04–0.17]), however this was not as pronounced at day 28 (median Bray-Curtis score day 0 vs day 28 = 0.38 [0.11–0.59]). A decrease in the prevalence and abundance of BV-associated bacteria in the cutaneous penile microbiota was observed immediately following treatment at day 8.ConclusionCombined oral and topical treatment of male partners of women with BV is acceptable and well tolerated. The combined acceptability and microbiological data presented in this paper supports the need for larger studies with longer follow up to characterize the sustained effect of dual partner treatment on the genital microbiota of couples and assess the impact on BV recurrence.

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Section: Discussionmentioning

confidence: 99%

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study

et al. 2018

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“…However, both analyses showed that the four TMA tests detected all nine strains at a titer at less than 1 GE/ml of specimen, indicating that the risk of a clinical false-negative result due to the analytical sensitivity capability of each test is likely to be small. We also did not have clinical penile meatal swab specimens, a potentially important new specimen type for STI testing (42,43), to compare with test LOD capability in that specimen matrix. Finally, we did not compare test clinical performance to an absolute reference standard such as PCR Sanger sequencing for the identification of M. genitalium infection.…”

Section: Discussionmentioning

confidence: 99%

Design and Validation of Transcription-Mediated-Amplification Nucleic Acid Amplification Tests for Mycoplasma genitalium

et al. 2019

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Mycoplasma genitalium is a sexually transmitted bacterium linked to adverse sexual and reproductive health outcomes in women and men. M. genitalium is difficult to culture, and in the absence of validated amplified molecular methods for diagnosis of infection, there is no reference standard available for use as a comparator for the validation of new M. genitalium diagnostic tests. We evaluated the analytical and clinical performance of three transcription-mediated amplification (TMA) tests for M. genitalium, each targeting unique rRNA sequences, for use as a composite comparator for clinical validation of the Aptima Mycoplasma genitalium (AMG) assay, an in vitro diagnostic (IVD) TMA test that targets 16 s rRNA of M. genitalium. Analytical sensitivity, specificity, and strain inclusivity of all four TMA tests were determined using nine laboratory strains of M. genitalium and 56 nontarget bacteria, protozoa, and viruses. Analytical sensitivity of the tests for M. genitalium ranged from 0.017 to 0.040 genome equivalents/ml. None of the nontarget organisms evaluated cross-reacted with any test. A composite comparator reference standard consisting of the 3 alternate (Alt) TMA tests was used to evaluate the clinical performance of the AMG assay by testing residual vaginal swab, female urine, and male urine specimens obtained from 1,400 adult subjects from three U.S. clinical sites. Using this reference standard to establish infected specimen status, the sensitivity, specificity, and overall agreement of the AMG IVD assay were 100%, 99.9%, and 99.9%, respectively. These results demonstrate the utility of molecular composite reference standard methodology for the clinical validation of future IVD tests for this organism.

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“…Less-invasive means of specimen collection, such as first-void urine or self-collected vaginal swab options, may promote a higher screening frequency, particularly in scenarios that do not require a physical examination. Furthermore, Dize et al (32) reported that M. genitalium ASR performed on self-collected penile-meatal swabs (investigated in a U.S. STI clinic with 14% M. genitalium prevalence) yielded performance indices equivalent to those derived from clinician-collected urethral swabs.…”

Section: Discussionmentioning

confidence: 99%

Molecular Diagnostics Update for the Emerging (If Not Already Widespread) Sexually Transmitted Infection Agent Mycoplasma genitalium: Just About Ready for Prime Time

Munson

2017

J Clin Microbiol

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Mycoplasma genitalium is an important and emerging agent of sexually transmitted infection in females and males, carrying the potential for postinfection genital tract sequelae. Past efforts to identify this organism on a routine basis, which were problematic due to the fastidious nature of the bacterium and its antigenic intricacies, have recently become supplemented by molecular diagnostics. A number of these assays are available commercially. This minireview describes the format and performance indices of a number of M. genitalium DNA-and RNA-based amplification assays; many of these assays have contributed to an improved clinical and epidemiologic understanding of this organism.

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Performance of self-collected penile-meatal swabs compared to clinician-collected urethral swabs for the detection of Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , and Mycoplasma genitalium by nucleic acid amplification assays

Cited by 39 publications

References 20 publications

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study

Design and Validation of Transcription-Mediated-Amplification Nucleic Acid Amplification Tests for Mycoplasma genitalium

Molecular Diagnostics Update for the Emerging (If Not Already Widespread) Sexually Transmitted Infection Agent Mycoplasma genitalium: Just About Ready for Prime Time

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