Aptima® Mycoplasma genitalium Test

Mycoplasma genitalium (M. gen) is a highly prevalent STI

Testing for M. gen is recommended by the Centers for Disease Control and Prevention (CDC) for patients with recurrent nongonoccal urethritis (NGU), recurrent cervicitis, and Pelvic Inflammatory Disease (PID).1 Both women and men with M. gen infections can be asymptomatic and when left untreated, this infection can result in serious health consequences.1

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Women

  • Frequently asymptomatic1
  • Detected in 10%-30% of women with clinical cervicitis1
  • Prevalence of M. genitalium is identified in up to 22% of pelvic inflammatory disease (PID) cases1
  • Untreated PID can lead to adverse pregnancy outcomes1
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Men

  • Responsible for 40% of persistent or recurrent urethritis in men1
Chart 1

Proper treatment depends on proper diagnosis

The treatment for each infection is organism-specific.1 An accurate diagnosis is critical to ensuring infections are treated successfully.
Recommended treatments from CDC STI Treatment Guidelines 2021 are organism-specific
Chlamydia1
  • Doxycycline
    100 mg orally 2x / day for 7 days
Gonorrhea1
  • Ceftriaxone
    500 mg* IM in a single dose for persons weighing <150 kg
  • If chlamydial infection has not been excluded, treat for chlamydia with Doxycycline 100 mg orally 2 times/day for 7 days

* For persons weighing ≥150 kg, 1 g Ceftriaxone should be administered.

Trichomoniasis1
  • Women:
    Metronidazole
    500 mg orally 2 times/day for 7 days
  • Men:
    Metronidazole
    2 g orally in a single dose
Treatment considerations
M. GEN. 1

A two-stage therapy approach accompanied with resistance testing, if available, is recommended for treating M. gen. 1

  • Recommended Regimens if M. gen Resistance Testing Is Available:
    • If macrolide sensitive: 100 mg orally 2x/day for 7 days of Doxycycline, followed by 1 g orally initial dose of Azithromycin, followed by 500 mg orally 1x/ day for an additional 3 days (2.5 g total) of Azithromycin.
    • If macrolide resistant: 100 mg orally 2x/day for 7 days of Doxycycline, followed by 400 mg orally 1x/ daily for 7 days of Moxifloxacin
  • Recommended Regimen if M. gen Resistance Testing Is NOT Available:
    • 100 mg orally 2x/day for 7 days of Doxycycline, followed by 400 mg orally 1x/daily for 7 days of Moxifloxacin

 

The content in this piece is for information purposes only and is not intended to be medical advice.

The Aptima® Mycoplasma genitalium assay, a Nucleic Acid Amplification Test (NAAT), has up to 100% sensitivity.12‡ The Aptima® assay targets rRNA and out-performed DNA tests.13-14*†

M. gen infection contains a very low organism load compared to other infections.15 Peer-reviewed article reported that the rRNA-based Aptima M. gen assay had higher clinical sensitivity compared to that of DNA-based assay.13-14 The CDC recommends NAATs for detection of M. gen.1
Sensitivity of Detection in Patients with M. gen Infections:12-14

%

Aptima® M. genitalium assay RNA-based test

%

Aptima® M. genitalium assay RNA-based test

%

DNA-based LDT test

%

DNA-based test
*Sensitivity from peer-reviewed article Le Roy et al. study
†Sensitivity from peer-reviewed Unemo et al. study
‡Sensitivity information provided above is specific to patient-collected
vaginal swab (PVS) for symptomatic patients. For complete performance
characteristics for the Aptima Mycoplasma genitalium assay, please refer to
the package insert.
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References

1. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR Recomm Rep 2021;70 2. Kent H. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(4):1168-1176 3. Manhart LE, Gaydos CA, Taylor SN, Lillis RA, Hook EW 3rd, Klausner JD, Remillard CV, Love M, McKinney B, Getman DK. Characteristics of Mycoplasma genitalium Urogenital Infections in a Diverse Patient Sample from the United States: Results from the Aptima Mycoplasma genitalium Evaluation Study (AMES). J Clin Microbiol. 2020 Jun 24;58(7):e00165-20. doi: 10.1128/JCM.00165-20. PMID: 32321783; PMCID: PMC7315021. 4. Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15. PMID: 21524046. 5. Bautista CT, Wurapa EK, Sateren WB, Morris SM, Hollingsworth BP, Sanchez JL. Association of Bacterial Vaginosis With Chlamydia and Gonorrhea Among Women in the U.S. Army. Am J Prev Med. 2017 May;52(5):632-639. doi: 10.1016/j.amepre.2016.09.016. 6. CDC. Trichomonas Fact Sheet. Center for Disease Control and Prevention website. Last reviewed April 25, 2022. Accessed March 10, 2023. https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm 7. CDC. Bacterial Vaginosis Fact Sheet. Center for Disease Control and Prevention website. Last reviewed January 5, 2022. Accessed March 10, 2024. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm 8. CDC. Candida Fact Sheet. Center for Disease Control and Prevention website. Last reviewed July 13, 2022. Accessed March 10, 2024. https://www.cdc.gov/fungal/diseases/candidiasis/genital/index.html 9. CDC. Chlamydia Fact Sheet. Center for Disease Control and Prevention website. Last reviewed April 12, 2024. Accessed March 10, 204. https://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm 10. CDC. Gonorrhea – CDC Detailed Fact Sheet. Center for Disease Control and Prevention website. Last reviewed April 11, 2023. Accessed July 11, 2023. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea-detailed.htm 11. CDC. Mycoplasma genitalium – CDC Detailed Fact Sheet. Center for Disease Control and Prevention website. Last reviewed December 5, 2022. Accessed June 1, 2023. https://www.cdc.gov/std/mgen/stdfact-Mgen-detailed.htm 12. Aptima Mycoplasma genitalium assay [packet insert]. AW-17946, San Diego, CA; Hologic, Inc., 2024. 13. 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. 14. Unemo M, et al. Clinical and analytical evaluation of the new Aptima Mycoplasma genitalium assay, with data on M. genitalium prevalence and antimicrobial resistance in M. genitalium in Denmark, Norway and Sweden in 2016. Clin Microbiol Infect. 2018;24(5):533-539. 15. 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 3. 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. JClin Microbiol. 2017;55(11):3194-3200.