Mycoplasma genitalium detection in urogenital specimens from symptomatic and asymptomatic men and women by use of the cobas TV/MG test

Barbara Van Der Pol, Ken B. Waites, Li Xiao, Stephanie N. Taylor, Arundhati Rao, Melinda Nye, Steven Chavoustie, Aaron Ermel, Clair Kaplan, David Eisenberg, Philip A. Chan, Leandro Mena, Sixto Pacheco, Smitha Krishnamurthy, Ruchika Mohan, Rasa Bertuzis, Chris L. McGowin, Rodney Arcenas, Elizabeth M. Marlowe

Research output: Contribution to journalArticle

Abstract

Mycoplasma genitalium (MG) infections are a growing concern within the field of sexually transmitted infections. However, diagnostic assays for M. genitalium have been limited in the United States. As most infections are asymptomatic, individuals can unknowingly pass the infection on, and the prevalence is likely to be underestimated. Diagnosis of M. genitalium infection is recommended using a nucleic acid test. This multicenter study assessed the performance of the cobas Trichomonas vaginalis (TV)/MG assay (cobas) for the detection of M. genitalium, using 22,150 urogenital specimens from both symptomatic and asymptomatic men and women collected at geographically diverse sites across the United States. The performance was compared to a reference standard of three laboratory-developed tests (LDTs). The specificity of the cobas assay for M. genitalium ranged from 96.0% to 99.8% across symptomatic and asymptomatic men and women. The sensitivities in female vaginal swabs and urine samples were 96.6% (95% confidence interval [CI], 88.5 to 99.1%) and 86.4% (95% CI, 75.5 to 93.0%), respectively. The sensitivities in male urine and meatal swab samples were 100% (95% CI, 94.0 to 100%) and 85.0% (95% CI, 73.9 to 91.9%), respectively. This study demonstrated that the cobas assay was highly sensitive and specific in all relevant clinical samples for the detection of M. genitalium.

Original languageEnglish (US)
Article numbere02124-19
JournalJournal of clinical microbiology
Volume58
Issue number6
DOIs
StatePublished - Jun 2020

Keywords

  • Cobas TV/MG
  • Genital disease
  • Genital infection
  • Molecular diagnostics
  • Mycoplasma genitalium
  • PCR

ASJC Scopus subject areas

  • Microbiology (medical)

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  • Cite this

    Van Der Pol, B., Waites, K. B., Xiao, L., Taylor, S. N., Rao, A., Nye, M., Chavoustie, S., Ermel, A., Kaplan, C., Eisenberg, D., Chan, P. A., Mena, L., Pacheco, S., Krishnamurthy, S., Mohan, R., Bertuzis, R., McGowin, C. L., Arcenas, R., & Marlowe, E. M. (2020). Mycoplasma genitalium detection in urogenital specimens from symptomatic and asymptomatic men and women by use of the cobas TV/MG test. Journal of clinical microbiology, 58(6), [e02124-19]. https://doi.org/10.1128/JCM.02124-19