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Mycoplasma genitalium, rRNA, TMA

Test Code(s) 91475

Mgen is a sexually transmitted infection (STI) that is spread, primarily, through direct genital to genital contact. Once Mgen 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, Mgen 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

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

Cervicitis

Mgen is an etiological factor in the development of cervicitis, a condition characterized by inflammation of the cervix that can cause bleeding, abnormal discharge, and pain. Mgen is associated with 10% to 30% of diagnosed cervicitis.4,8

PID

Mgen is an etiological factor in the development of PID, a condition that affects approximately 2.5 million reproductive-aged women in the United States annually.4 PID develops when untreated STIs ascend into the upper reproductive tract and induce inflammatory conditions including endometritis, salpingitis, and pelvic peritonitis. The development of nucleic acid amplification tests (NAATs) led to the identification of Mgen as one of the most prevalent STIs associated with PID, having been detected in 4% to 22% of acute PID cases.4,9-12

No. Mgen is an extremely slow-growing organism. Culture can take up to 6 months, and technical laboratory capacity is limited to research settings.2 Mgen lacks a cell wall and cannot be viewed under a microscope.2 Per the Centers for Disease Control and Prevention, a 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 Mgen on the fully automated Panther® system.14 It is intended for use as an aid in the diagnosis of Mgen urogenital infections in male and female patients.

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

a Includes C trachomatis; N gonorrhoeae; T vaginalis and M genitalium

b Includes C trachomatis; N gonorrhoeae; T vaginalis; M genitalium; U 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 Mgen; 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 Mgen infection is suspected. Pap vial is not an acceptable collection device for this test.

Table 2. Acceptable Specimen Types
Swab type Collection device Collection device label
Vaginal swabc Aptima® multitest collection kit Orange label
Penile Meatal swabc Aptima® multitest collection kit Orange label
Endocervical swab Aptima® unisex collection kit White label
Male urethral swab Aptima® unisex collection kit White label
Male/female urine Aptima® urine collection kit Yellow label

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. 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/sites/default/files/2019-07/AW-17946_002_01.pdf

 

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.

 

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