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Aptima® Mycoplasma genitalium Assay

Mycoplasma genitalium (M. gen) is a Common† STI

Among women, M. gen has been associated with cervicitis, Pelvic Inflammatory Disease (PID), preterm delivery, spontaneous abortion, and infertility.1 Women infected with M. gen have an approximately twofold increase in the risk for these outcomes. 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 PID.1

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Women

  • Frequently asymptomatic1
  • Prevalence of 17.6% in high risk populations2
  • Detected in 10%–⁠30% of women with clinical cervicitis1
  • M. gen is identified in up to 22% of PID cases1
  • Untreated PID can lead to adverse pregnancy outcomes1
Men Icon

Men

  • Symptoms may include discharge and dysuria (burning sensation)3
  • Prevalence of 15.9% in high risk populations2
  • Responsible for 40% of persistent or recurrent urethritis in men1

M. gen Shares Many Clinical Presentation Symptoms with Trichomoniasis, Chlamydia, Gonorrhea and Vaginitis3-13

Mycoplasma genitalium chart

Proper Diagnosis is Important to Drive the Right Treatment Decisions

The treatment for each infection is organism-specific.1 An accurate diagnosis is critical to ensuring infections are treated appropriately.

Recommended treatments from CDC STI Treatment Guidelines 2021 are organism-specific1

Chlamydia

  • Doxycycline: 100 mg orally 2x/day for 7 days

Gonorrhea

  • 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 2x/day for 7 days.
    •  For persons weighing ≥150 kg, 1 g Ceftriaxone should be administered.

Trichomoniasis

  • Women: Metronidazole 500 mg orally 2x/day for 7 days
  • Men: Metronidazole 2 g orally in a single dose

M. gen treatment considerations1

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

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
  • 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 informational purposes only and is not intended to be medical advice.

The Test You Choose Matters

The Aptima® Mycoplasma genitalium Assay targets rRNA and out-performed tests that target DNA.

M. gen infection contains a very low organism load compared to other infections, which can make detection difficult.14 
By targeting rRNA, the Aptima® Mycoplasma genitalium Assay demonstrated up to 100% sensitivity, outperforming DNA tests.15-17

Sensitivity of Detection in Patients with M. gen Infections15-17

%

Aptima® Mycoplasma genitalium Assay
rRNA-based test

%

DNA-based
LTD

%

DNA-based test

*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.17

†Sensitivity from peer-reviewed article Le Roy et al. study

‡Sensitivity from peer-reviewed Unemo et al. study

The CDC recommends NAATs to detect M. gen.1

Specimen Type Aptima® Mycoplasma genitalium Assay17
Sensitivity Specificity
Multitest Swab

Multitest Swab

Clinician Collected Vaginal Sample

 92% 98%

Multitest Swab

Patient Collected Multitest Swab

 98.9% 98.5%

Multitest Swab

Penile Meatal Sample

 88.4% 97.8%
Unisex Collection

Female Endocervical Swab

Clinician Collected Endocervica

 81.5% 98.3%

Male Urethral Swab

Clinician Collected Endocervica

 98.2% 99.6%
Urine Collection

Aptima® Urine

Female Sample

 77.8% 99%

Aptima® Urine

Male Sample

 90.9% 99.4%

Specimen Type

Aptima® Mycoplasma
genitalium Assay17

Multitest Swab - Vaginal
Sensitivity Specificity
92% 98%
Multitest Swab - Patient Collected
Sensitivity Specificity
98.9% 98.5%
Multitest Swab - Penile Meatal
Sensitivity Specificity
88.4% 97.8%
Female Endocervical Swab
Sensitivity Specificity
81.5% 98.3%
Male Urethral Swab
Sensitivity Specificity
98.2% 99.6%
Aptima® Urine - Female
Sensitivity Specificity
77.8% 99%
Aptima® Urine - Male
Sensitivity Specificity
90.9% 99.4%

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References

†In “high risk” populations defined by patients attending an STI clinic, patients presenting to family planning clinics for termination of pregnancy, symptoms of urogenital disease and/or sex workers.

1. CDC. Morbidity and Mortality Weekly Report Sexually Transmitted Infections Treatment Guidelines, 2021 Centers for Disease Control and Prevention MMWR Editorial and Production Staff (Serials) MMWR Editorial Board.; 2021. Accessed February 20, 2026. https://www.cdc.gov/std/treatment-guidelines/STI-Guidelines-2021.pdf

2. Manhart LE, Leipertz G, Soge OO, Jordan SJ, McNeil C, Pathela P, Reno H, Wendel K, Parker A, Geisler WM, Getman D, Golden MR; MyGeniUS Study Team. Mycoplasma genitalium in the US (MyGeniUS): Surveillance Data From Sexual Health Clinics in 4 US Regions. Clin Infect Dis. 2023 Nov 17;77(10):1449-1459. doi: 10.1093/cid/ciad405.

3. CDC. About Mycoplasma genitalium. Last reviewed: January 31, 2025. Accessed February 10, 2026. https://www.cdc.gov/mgen/about/index.html

4. Kent H. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991;165(4):1168-1176.

5. 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.

6. Hainer BL, Gibson MV. Vaginitis. Am Fam Physician. 2011 Apr 1;83(7):807-15. PMID: 21524046.

7. 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.

8. Center for Disease Control and Prevention. About Trichomoniasis. Last reviewed January 31, 2025. Accessed February 20, 2026. https://www.cdc.gov/trichomoniasis/about/index.html

9. Center for Disease Control and Prevention. About Bacterial Vaginosis (BV). Last reviewed December 11, 2023. Accessed February 20, 2026. https://www.cdc.gov/bacterial-vaginosis/about/index.html

10. Center for Disease Control and Prevention. Symptoms of Candidiasis. Last reviewed April 24, 2024. Accessed February 20, 2026. https://www.cdc.gov/candidiasis/signs-symptoms/index.html

11. Center for Disease Control and Prevention. About Chlamydia. Last reviewed January 31, 2025. Accessed February 20, 2026. https://www.cdc.gov/chlamydia/about/index.html

12. Center for Disease Control and Prevention. About Gonorrhea. Last reviewed January 31, 2025. Accessed February 20, 2026. https://www.cdc.gov/gonorrhea/about/index.html

13. Martin DH. Mycoplasma genitalium infection in males and females. Last updated July 14, 2023. Accessed February 20, 2026. https://www.uptodate.com/contents/mycoplasma-genitalium-infection-in-males-and-females

14. 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.

15. 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.

16. 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.

17. Aptima Mycoplasma genitalium assay. US package insert AW-17946. Hologic, Inc.; 2024.