Aptima® Mycoplasma genitalium Test

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

Testing for M. gen is recommended for all patients with recurrent urethritis, cervicitis and PID.1 Both women and men with M. gen infections are often asymptomatic and when left untreated, this infection can result in serious health consequences.1,2

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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
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Proper treatment depends on proper diagnosis

The treatment for each infection is organism-specific. An accurate diagnosis is critical to ensuring infections are treated successfully.3
Recommended treatments are organsim-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

DNA-based tests can miss 40% of infections compared to rRNA-based tests.15

M. gen infection contains a very low organism load compared to other infections.14 Our RNA-based NAAT is far more sensitive than DNA-based tests—it accurately identified the 40% of patients with M. gen infections missed by DNA-based testing.15 The CDC recommends NAATs for detection of M. gen.1
Sensitivity of detection in patients with known M. genitalium infections:15,16

%

Aptima® M. genitalium assay RNA-based test

%

Aptima® M. genitalium assay RNA-based test

%

DNA-based LDT test

%

DNA-based test
*Sensitivity from Le Roy Study
†Sensitivity from Unemo Study. Performance in vaginal specimen.
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1. Workowski, et al. Sexually Transmitted Infections Treatment Guidelines 2021. MMWR RecommRep 2021;70 2. Jensen et al., Mycoplasma genitalium: prevalence, clinical significance, and transmission. Sex Transm Infect 2005;81:458–462. 3. Kent H. Epidemiology of vaginitis. Am J bstet Gynecol. 1991;165(4):1168-1176. 4. 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. 5. Lis R, Rowhani-Rahbar A, Manhart LE. Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis. Clin Infect Dis. 2015 Aug 1;61(3):418-26. doi: 10.1093/cid/civ312. Epub 2015 Apr 21. PMID: 25900174. 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. Epub 2016 Nov 3. PMID: 27816380. 8. CDC. M. gen Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/mgen/stdfact-Mgen.htm 9. CDC. Trichomonas Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm 10. CDC. Bacterial Vaginosis Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm 11. CDC. Candida Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/fungal/diseases/candidiasis/genital/index.html 12. CDC. Chlamydia Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm 13. CDC. Gonorrhea Fact Sheet. Center for Disease Control and Prevention website. Last reviewed February 15, 2023. Accessed February 15, 2023. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrhea.htm 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. 15. Le Roy q, et al. French prospective clinical evaluation of the Aptima Mycoplasma genitalium qE-IVD assay and macrolide resistance detection using three distinct assays. J qlin Microbiol. 2017;55(11):3194-3200. 16. Unemo M, et al. qlinical 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. qlin Microbiol Infect. 2018;24(5):533-539.