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Mycoplasma genitalium, rRNA, TMA

Test Codes: 18456, 91475

M genitalium is a sexually transmitted infection (STI) that is spread, primarily, through direct genital to genital contact. Once M genitalium has been contracted, the bacterium adheres to the epithelial lining of the urogenital tract, adopting a parasitic lifestyle and activating the innate immune system.1-3

In some cases, M genitalium can establish persistent infection and manifest as urogenital diseases such as urethritis in men and cervicitis or pelvic inflammatory disease (PID) in women.4,5

Nongonococcal urethritis

Nongonococcal urethritis (NGU) is the most common clinical manifestation of M genitalium in men in the United States, and M genitalium causes between 15% and 25% of NGU.6 M genitalium-associated NGU presents with the same symptoms as other causal pathogens, including dysuria and urethral discharge. However, M genitalium-associated NGU is more likely to be symptomatic compared to chlamydia-associated disease.7

Cervicitis

M genitalium is associated with 10% to 30% of diagnosed cervicitis, a condition characterized by inflammation of the cervix that can cause bleeding, abnormal discharge, and pain.4,8

PID

PID, a condition that affects approximately 2.5 million reproductive-aged women in the United States annually, develops when untreated sexually transmitted infections (STIs) ascend into the upper reproductive tract and induce inflammatory conditions including endometritis, salpingitis, and pelvic peritonitis. 4

The development of nucleic acid amplification tests (NAATs) led to the identification of M genitalium as one of the most prevalent STIs associated with PID, being detected in 4% to 22% of acute PID cases.4,9-12

No. M genitalium is an extremely slow-growing organism. Culture can take up to 6 months, and technical laboratory capacity is limited to research settings.2 M genitalium lacks a cell wall and cannot be viewed under a microscope.2

Per the Centers for Disease Control and Prevention, a nucleic acid amplification tests (NAAT) cleared by the Food and Drug Administration (FDA) is the preferred method of testing.13

Quest currently uses the FDA-cleared Aptima® Mycoplasma genitalium assay. This assay is an in vitro NAAT for the qualitative detection of ribosomal RNA (rRNA) from M genitalium on the fully automated Panther® system.14 It is intended to aid in the diagnosis of M genitalium urogenital infections in male and female patients. 

Table 1. M genitalium Test Codes and Panels
Test codeTest name
91475Mycoplasma genitalium, rRNA, TMA
36962Sexually-Transmitted Infections (STIs) Cervicitis Panela
36965Sexually-Transmitted Infections (STIs) Pelvic Inflammatory Disease (PID) Panela
36964Sexually-Transmitted Infections (STIs) Male Urethritis Panela
38288Sexually-Transmitted Infections (STIs) Male Urethritis Panel, Expandedb

a Includes Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and M genitalium.

b Includes C trachomatis, N gonorrhoeae, T vaginalis, M genitalium, Ureaplasma parvum, and U urealyticum.

Components of all panels are available separately: C trachomatis (test code: 11361); N gonorrhoeae (test code:11362); C trachomatis/N gonorrhoeae (test code:11363); T vaginalis (test code: 19550); Ureaplasma species (test code: 91476); and M hominis (test code 91474)

The assay may be used to test the following specimen types: clinician-collected and self-collected (in a clinical setting) vaginal swabs, clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected (in a clinical setting) penile meatal swabs (Table 2).14

For females, a vaginal swab is the preferred specimen type because it yields higher clinical sensitivity than other specimen types for detecting M genitalium; however, female urine or clinician-collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M genitalium infection is suspected. Pap vial is not an acceptable collection device for this test.

Table 2. Acceptable Specimen Types
Swab typeCollection deviceCollection device label color
Vaginal swabaAptima® multitest collection kitOrange
Penile Meatal swabaAptima® multitest collection kitOrange
Endocervical swabAptima® unisex collection kitWhite
Male urethral swabAptima® unisex collection kitWhite
Male/female urineAptima® urine collection kitYellow

The prevalence of macrolide resistance varies by geographic location and population.

In one meta-analysis, the rates ranged from 6.3% to 52.3% based on WHO region, with the Americas region having the highest rate.15 Several multi-center studies in the United States, which included symptomatic and asymptotic individuals seeking sexually transmitted infection (STI) testing, demonstrated rates between 42% and 59% in samples positive for M genitalium.13,16-18

Yes, Quest Diagnostics offers the Mycoplasma genitalium rRNA, NAAT with Reflex to Macrolide Resistance algorithm (test code 18456). The Aptima® Mycoplasma genitalium assay is first performed to determine the presence or absence of the organism in the patient sample. If detected, a second test is performed to determine the presence of genes that confer resistance to macrolide antibiotics.

The macrolide resistance assay is only offered as a reflex from an M genitalium detection assay because resistance testing should only be performed on samples confirmed to be positive for M genitalium. Macrolide resistance testing is not performed on samples with negative results for M genitalium.

This test is not part of the STI panels listed in Table 1. 

The assay detects macrolide resistance-associated mutations within the 23S rRNA gene. The mutations detected include A2058G, A2058T, A2058C, A2059G, and A2059C. The mutations are not differentiated by the assay because the specific mutation is not necessary to choose a treatment.

For the latest treatment information, please refer to the Centers for Disease Control and Prevention STI Treatment Guidelines.13

While a “detected” result indicates the presence of genes associated with macrolide resistance, a “not detected” result may not always correlate with susceptibility. This is due to analytical sensitivity differences between the assay used to detect M genitalium and the assay used to detect genes conferring antimicrobial resistance. Resistance to macrolide antibiotics may still be possible in samples with low but detectable levels of M genitalium nucleic acid.

References

  1. Ma L, Jensen JS, Myers L, et al. Mycoplasma genitalium: an efficient strategy to generate genetic variation from a minimal genome. Mol Microbiol. 2007;66(1):220-236. doi:10.1111/j.1365-2958.2007.05911.x
  2. McGowin CL, Totten PA. The unique microbiology and molecular pathogenesis of Mycoplasma genitalium. J Infect Dis. 2017;216(suppl_2):S382-S388. doi:10.1093/infdis/jix172
  3. Dehon PM, McGowin CL. The immunopathogenesis of Mycoplasma genitalium infections in women: a narrative review. Sex Transm Dis. 2017;44(7):428-432. doi:10.1097/OLQ.0000000000000621
  4. Lis R, Rowhani-Rahbar A, Manhart LE. Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis. Clin Infect Dis. 2015;61(3):418-426. doi:10.1093/cid/civ312
  5. Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Microbiol Rev. 2011;24(3):498-514. doi:10.1128/CMR.00006-11
  6. Horner PJ, Martin DH. Mycoplasma genitalium infection in men. J Infect Dis. 2017;216(suppl_2):S396-S405. doi:10.1093/infdis/jix145
  7. Falk L, Fredlund H, Jensen JS. Symptomatic urethritis is more prevalent in men infected with Mycoplasma genitalium than with Chlamydia trachomatis. Sex Transm Infect. 2004;80(4):289-293. doi:10.1136/sti.2003.006817
  8. Gaydos C, Maldeis NE, Hardick A, et al. Mycoplasma genitalium as a contributor to the multiple etiologies of cervicitis in women attending sexually transmitted disease clinics. Sex Transm Dis. 2009;36(10):598-606. doi:10.1097/OLQ.0b013e3181b01948
  9. Bjartling C, Osser S, Persson K. Mycoplasma genitalium in cervicitis and pelvic inflammatory disease among women at a gynecologic outpatient service. Am J Obstet Gynecol. 2012;206(6):476.e1-476.e8. doi:10.1016/j.ajog.2012.02.036
  10. Lillis RA, Martin DH, Nsuami MJ. Mycoplasma genitalium infections in women attending a sexually transmitted disease clinic in New Orleans. Clin Infect Dis. 2019;69(3):459-465. doi:10.1093/cid/ciy922
  11. 11.  Lillis RA, Nsuami MJ, Myers L, et al. Utility of urine, vaginal, cervical, and rectal specimens for detection of Mycoplasma genitalium in women. J Clin Microbiol. 2011;49(5):1990-1992. doi:10.1128/JCM.00129-11
  12. Trent M, Yusuf HE, Perin J, et al. Clearance of Mycoplasma genitalium and Trichomonas vaginalis among adolescents and young adults with pelvic inflammatory disease: results from the TECH-N study. Sex Transm Dis. 2020;47(11):e47-e50. doi:10.1097/OLQ.0000000000001221
  13. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1
  14. Aptima Mycoplasma genitalium Assay. Package insert. Hologic Inc; 2019. Accessed September 22, 2021. https://www.hologic.com/package-inserts/diagnostic-products/aptima-mycoplasma-genitalium-assay
  15. Machalek D, Tao Y, Shiling H, et al. Prevalence of mutations associated with resistance to macrolides and fluoroquinolones in Mycoplasma genitalium: a systematic review and meta-analysis. Lancet Infect Dis. 2020; 20(11):1302-1314.
  16. Getman D, Jiang A, O'Donnell M, et al. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States. J Clin Microbiol. 2016;54(9):2278-83. doi:10.1128/JCM.01053-16
  17. Manhart LE, Leipertz G, Soge OO, et al.  Mycoplasma genitalium in the US (MyGeniUS): Surveillance data from sexual health clinics in 4 US Regions. Clin Infect Dis. 2023;77(10):1449–1459. doi: 10.1093/cid/ciad405
  18. Getman D, Cohen S, Jiang A. Distribution of macrolide resistant Mycoplasma genitalium in urogenital tract specimens from women enrolled in a US clinical study cohort. Clin Infect Dis. 2023;76(3):e776-e782. doi: 10.1093/cid/ciac602

 

This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the individual.

 

Document FAQS.271 Version: 1

Version 1: Effective 05/18/2026 to present

Version 0: Effective 10/22/2021 to 5/18/2026 

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