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Aptima® Mycoplasma genitalium assay

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    Overview

    Mycoplasma genitalium (M. gen) is an emerging health concern

    Testing for M. gen is recommended for all patients with recurrent urethritis, cervicitis and PID.1 Both women and men with M. gen infections are often asymptomatic and when left untreated, this infection can result in serious health consequences.1,2
     

    Women

    • Frequently asymptomatic2
    • Detected in 10%-30% of women with clinical cervicitis1,2
    • Identified in up to 22% of pelvic inflammatory disease (PID) cases1
    • Untreated PID can lead to adverse pregnancy outcomes1
       

    Men

    • More likely to exhibit symptoms of M. gen infection2
    • Responsible for 40% of persistent or recurrent urethritis in men1

    Proper treatment depends on proper diagnosis

    Often misdiagnosed, M. gen presents similar symptoms with other urogenital tract bacterial infections, such as Trichomoniasis, Chlamydia or Gonorrhea.3,4 However, treatment for these infections is organism-specific. Accurate diagnosis is critical to ensuring infections are treated successfully.

    NAAT is the CDC recommended method for detection of M. gen1

    When identifying M. gen, the test you choose matters. Infections carry very low bacterial loads, and each organism contains 1000s of rRNA copies versus only one copy of DNA. RNA-based NAAT is far more sensitive than DNA-based tests.5,6

    DNA-based tests can miss as much as 40% of infections compared to rRNA-based tests.6

    The rRNA-based Aptima® Mycoplasma genitalium assay provides up to 100% sensitivity.6,7

    Streamline testing for sexual and vaginal health

    Test for M. gen with the Aptima® Multitest swab. The Aptima® portfolio powers efficient, streamlined testing with assay and collection consolidation on scalable automation.

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    Alternative Specimen Collection Also Available

    Urine

    • Female urine (first catch)
    • Male urine (first catch)

    Unisex Swab

    • Endocervical swabs
    • Male urethral swabs
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    References: 1. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR RecommRep 2021;70 2. Jensen et al., Mycoplasma genitalium: prevalence, clinical significance, and transmission. Sex Transm Infect 2005;81:458–462. 3. Martin D. Mycoplasma genitalium infection in men and women. UpToDate. Last updated October 31, 2019. Accessed August 20, 2020. https://www.uptodate.com/contents/mycoplasma-genitalium-infection-in-men-and-women. 4. Kent HL. Epidemiology of vaginitis. 5. Frølund M, et al. Urethretis-associated pathogens in urine from men with non-gonococcal urethritis: a case-control study. Acta Derm Venereol. 2016;96(5):689-694. 6. Le Roy C, et al. French prospective clinical evaluation of the Aptima Mycoplasma genitalium CE-IVD assay and macrolide resistance detection using three distinct assays. J Clin Microbiol. 2017;55(11):3194-3200. 7. Aptima Mycoplasma genitalium assay. US package insert AW-17946. Hologic, Inc., 2019. 

    Aptima® Mycoplasma genitalium Safety Data Sheets

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    Aptima® Mycoplasma genitalium assay

    Find Support
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    Information provided on this tab is intended for audiences outside the United States. Consult "USA" tab for products and claims available in the United States

      Overview

      Expand your menu with a significant, emerging STI

      Mycoplasma genitalium (M. gen) is an emerging STI present in approximately 10.2% of women and 10.6% of men.1 Often misdiagnosed, M. gen shows similar symptoms to chlamydia, gonorrhea, and trichomoniasis making it difficult to clinically identify.2

      When identifying M. gen, the test you choose matters

      M. gen infections carry very low bacterial loads, and each organism contains 1000s of rRNA copies versus only one copy of DNA. The rRNA-based NAAT Aptima Mycoplasma genitalium assay provides up to 100% sensitivity in the detection of M. gen, and this CE-marked test delivers results from multiple specimen types including vaginal swabs collected with the Aptima Multitest Swab.3,4

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      References: 1. Gaydos C, et al. Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study. J Clin Microbiol. 2019;57(11):e01125-19. Published October 23, 2019. doi.org/10.1128/JCM.01125-19 2. Martin D, Mycoplasma genitalium infection in men and women. UpToDate. Last updated April 2, 2021. Accessed September 10, 2021. 3. Le Roy C, Pereyre S, Hénin N, Bébéar C. French prospective clinical evaluation of the Aptima Mycoplasma genitalium CE-IVD assay and macrolide resistance detection using three distinct assays. J Clin Microbiol. 2017;55(11):3194-3200. 4. Aptima Mycoplasma genitalium assay. UK package insert AW-14170-001. Hologic, Inc., 2019. 

      Aptima® Mycoplasma genitalium Safety Data Sheets

      Learn More

      Related Products

      Aptima® STIs

      Aptima® STIs

      Aptima® Vaginal Health

      Aptima® Vaginal Health

      Aptima® Multitest Swab Specimen Collection Kit

      Aptima® Multitest Swab Specimen Collection Kit

      Panther® Scalable Solutions

      Panther® Scalable Solutions

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