Aptima® Mycoplasma genitalium Assay

A highly sensitive NAAT that seamlessly integrates into your lab's workflow to confirm M. gen.

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    A highly prevalent STI you can now accurately identify.

    Mycoplasma genitalium (M. gen) is an often misdiagnosed sexually transmitted infection (STI) with similar clinical presentation to chlamydia, gonorrhea and trichomoniasis.1,2 Testing for M. gen is recommended by the Centers for Disease Control and Prevention (CDC) for patients with persistent or recurrent cervicitis and urethritis, and should be considered for those with pelvic inflammatory disease (PID).

    Avoid Outdated Methods

    Conventional testing methods such as microscope and culture have made M. gen difficult to identify.3

    Prioritize Accuracy

    A highly sensitive rRNA test is needed for accurate diagnosis, as it provides a more abundant target than DNA.4

    Choose the Right Test

    Each M. gen organism contains 1000s of rRNA copies versus only one copy of DNA, making an RNA-based nucleic acid amplification test (NAAT) more sensitive than a DNA-based test.4

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    Receiving the Right Diagnosis

    The Aptima Mycoplasma genitalium assay offers a sensitive, rRNA-based NAAT that can detect characteristically low M. gen bacterial loads.5,6

    • CDC recommends NAAT to detect M. gen infection3
    • First FDA-cleared assay for M. gen7 
    • rRNA-based Aptima Mycoplasma genitalium assay provides up to 100% sensitivity. DNA-based tests can miss up to 40% of infections8

    Often Overlooked

    When there are symptoms, M. gen can present similarly to other urogenital tract bacterial infections. Overlapping symptoms can include abnormal discharge, vaginal irritation and pain during urination or sex.1,2

    Adverse Health Outcomes

    When left untreated, M. gen infections can result in serious health consequences.9

    Highly Prevalent

    Among women, M. gen prevalence is 10.2% and detected in 10-30% of clinical cervicitis cases and up to 22% of PID cases. Among men, M. gen prevalence is 10.6% and detected in 40% of recurrent urethritis cases.3,10

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    Expand Your Offering with the Aptima® Multitest Swab

    Testing for M. gen can be done using the Aptima Multitest Swab. The complete Aptima STI portfolio powers efficient, streamlined testing with assay and collection consolidation for sexual and vaginal health. 

    Aptima® Sexual and Vaginal Health Solution

    Learn how our tests help patients protect their sexual and reproductive health.

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    Evidence. Insight. Engagement.

    Explore resources on Hologic’s Medical Education site to learn more about our innovative technology, view the latest clinical and scientific evidence and see how you can help improve patient care.

      1. 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. 2. Kent H. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(4):1168- 1176. 3. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR RecommRep 2021;70. 4. Kirkconnell B, Weinbaum B, Santos K, et al. Design and Validation of Transcription-Mediated-Amplification Nucleic Acid Amplification Tests for Mycoplasma genitalium. J Clin Microbiol. 2019;57(8):e00264-19. Published 2019 Jul 26. doi:10.1128/JCM.00264-19. 5. Frølund M, et al. Urethritis-associated pathogens in urine from men with non-gonococcal urethritis: a case-control study. Acta Derm Venereol. 2016;96(5):689-694 6. Aptima Mycoplasma genitalium assay. US package insert AW-17946. Hologic, Inc., 2022. 7. FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium [press release]. Silver Spring, MD: FDA; January 23, 2019. 8. 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. JClinMicrobiol. 2017;55(11):3194-3200. 9.  Lis R., et al. Mycoplasma genitalium Infection and Female Reproductive Tract Disease: A Meta-analysis. Clinical Infectious Diseases® 2015;61(3):418–26. 10. 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.

      Safety Data Sheets

      Package Inserts


      Aptima Mycoplasma genitalium Assay Flashcard

      Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study