Trichomonas vaginalis detection in female specimens with cobas® TV/MG for use on the cobas® 6800/8800 systems

Marlowe, Elizabeth M.; Gohl, Peter; Steidle, Michael; Arcenas, Rodney; Bier, Carolin

doi:10.1556/1886.2019.00004

Cited by 13 publications

(8 citation statements)

References 17 publications

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“…In this study, the cobas assay was highly sensitive and specific for the detection of T. vaginalis in both male and female urogenital samples, with sensitivities greater than or similar to those seen with other NAATs for T. vaginalis ( 7 , 9 , 12 , 20 , 21 ). The sensitivity and specificity of cobas, when compared to the PIS, showed that male urine samples and female vaginal swab samples are preferred for detection of T. vaginalis infection.…”

Section: Discussionsupporting

confidence: 52%

Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

et al. 2021

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Trichomonas vaginalis is a prevalent sexually transmitted infection (STI). Diagnosis has historically relied on either microscopic analysis or culture, the latter being the previous gold standard. However, these tests are not readily available for male diagnosis, generally only perform well for symptomatic women, and are not as sensitive as nucleic acid amplification tests (NAATs). Men are largely asymptomatic but carry the organism and transmit to their sexual partners. This multicenter, prospective study evaluated the performance of the cobas® T. vaginalis /Myocoplasma genitalium (TV/MG) assay for detection of T. vaginalis DNA compared with patient infection status (PIS) defined by a combination of commercially available NAATs and culture using urogenital specimens. A total of 2,064 subjects (984 men and 1,080 women, 940 [45.5%] symptomatic, 1124 [54.5%] asymptomatic) were evaluable. In women, sensitivity ranged from 99.4% (95% confidence interval [CI] 96.8–99.9%) using vaginal samples to 94.7 (95% CI 90.2–97.2%) in PreservCyt samples. Specificity ranged from 98.9–96.8% (95% CI 95.4–97.8%). In men, the cobas TV/MG assay was 100% sensitive for the detection of T. vaginalis in both male urine samples and meatal swabs, with specificity of 98.4% in urine samples and 92.5% in meatal swabs. The cobas TV/MG is a suitable diagnostic test for the detection of T.vaginalis, which could support public health efforts towards infection control and complement existing STI programs.

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Section: Discussionsupporting

confidence: 52%

Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

et al. 2021

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“…Regarding the detection of M. genitalium, the sensitivity of the cobas MG/TV kit was 96.6% in female vaginal swabs and was 100% in male urine samples, while the specificity was 97.0% and 97.6%, respectively [9]. In addition, a study on 1648 female samples reported an overall sensitivity of 100% and a specificity of 99.5% for T. vaginalis detection [10].…”

Section: Discussionmentioning

confidence: 99%

“…Diagnostics, Luxembourg). The performance of the kits for C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis detection was compared to that of the cobas CT/NG and TV/MG kits (Roche Diagnostics, USA) [5][6][7][8][9][10]. For the two kits that also detect U. urealyticum, U. parvum and M. hominis, the detection performance was compared to that of published in-house TaqMan PCRs [11,12].…”

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confidence: 99%

Clinical performance of four multiplex real-time PCR kits detecting urogenital and sexually transmitted pathogens

Pereyre

Caméléna

Hénin

et al. 2022

Clinical Microbiology and Infection

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Participants will self-collect an additional vaginal specimen for chlamydia, gonorrhoea and trichomonas nucleic acid amplification testing on the Roche Cobas 6800 platform. 29 30 Standard-of-care HIV testing data will be obtained from participants’ electronic medical records at their respective gender health clinic, with written permission. HIV-positive TGM will be excluded as some studies have associated those with HIV having a more diverse vaginal microbiota, 31–33 although effective antiretroviral therapy 34 and regular BV testing and treatment 35 could moderate this risk.…”

Section: Methodsmentioning

confidence: 99%

“…REDCap is a secure, web-based software platform designed to support data capture for research studies, providing an intuitive interface for validated data capture, audit trails for tracking data manipulation and export procedures, automated export procedures for seamless data downloads to common statistical packages, and procedures for data integration and interoperability with external sources. Participants will self-collect an additional vaginal specimen for chlamydia, gonorrhoea and trichomonas nucleic acid amplification testing on the Roche Cobas 6800 platform 29 30. Standard-of-care HIV testing data will be obtained from participants’ electronic medical records at their respective gender health clinic, with written permission.…”

Section: Methodsmentioning

confidence: 99%

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study

et al. 2023

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IntroductionThe effect of testosterone (T) therapy on the vaginal microbiota of transgender men (TGM) is not well characterised, although one cross-sectional study comparing the vaginal microbiota of cisgender women to TGM on T≥1 year found that, in 71% of the TGM, the vaginal microbiota was less likely to beLactobacillus-dominated and more likely to be enriched with >30 other bacterial species, many associated with bacterial vaginosis (BV). This prospective study aims to investigate changes in the composition of the vaginal microbiota over time in TGM who retain their natal genitalia (ie, vagina) and initiate T. In addition, we will identify changes in the vaginal microbiota preceding incident BV (iBV) in this cohort while investigating behavioural factors, along with hormonal shifts, which may be associated with iBV.Methods and analysisT-naïve TGM who have not undergone gender-affirming genital surgery with normal baseline vaginal microbiota (ie, no Amsel criteria, normal Nugent Score with noGardnerella vaginalismorphotypes) will self-collect daily vaginal specimens for 7 days prior to initiating T and for 90 days thereafter. These specimens will be used for vaginal Gram stain, 16S rRNA gene sequencing and shotgun metagenomic sequencing to characterise shifts in the vaginal microbiota over time, including development of iBV. Participants will complete daily diaries on douching, menses and behavioural factors including sexual activity during the study.Ethics and disseminationThis protocol is approved through the single Institutional Review Board mechanism by the University of Alabama at Birmingham. External relying sites are the Louisiana State University Health Sciences Center, New Orleans Human Research Protection Program and the Indiana University Human Research Protection Program. Study findings will be presented at scientific conferences and peer-reviewed journals as well as shared with community advisory boards at participating gender health clinics and community-based organisations servicing transgender people.Registration detailsProtocol # IRB-300008073.

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Trichomonas vaginalis detection in female specimens with cobas® TV/MG for use on the cobas® 6800/8800 systems

Cited by 13 publications

References 17 publications

Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

Clinical performance of four multiplex real-time PCR kits detecting urogenital and sexually transmitted pathogens

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study

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