Aptima® Mycoplasma genitalium Test

Mycoplasma genitalium (M. gen) is an emerging health concern

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 asymptomatic2
  • Detected in 10%-30% of women with clinical cervicitis1,2
  • Identified in up to 22% of pelvic inflammatory disease (PID) cases1
  • Untreated PID can lead to adverse pregnancy outcomes1
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Men

  • More likely to exhibit symptoms of M. gen infection2
  • Responsible for 40% of persistent or recurrent urethritis in men1

Proper treatment depends on proper diagnosis

M. gen infection symptoms present similarly to those associated with other urogenital tract bacterial infections, such as Trichomoniasis, Chlamydia or Gonorrhea. 3,4

However, treatment for these infections is organism-specific. Accurate diagnosis is critical to ensuring infections are treated successfully.

Treatment is organism specific
Chlamydia 1
  • Doxycycline
    100 mg orally 2 times/day for 7 days
Gonorrhea 1
  • 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.

Trichomoniasis 1
  • Metronidazole
    500 mg orally 2 times/day for 7 days
Treatment considerations
M. GEN 1

Requires a two-stage therapy approach for treating M. gen. Testing should be accompanied with resistance testing, if available.

  • Stage 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 of Azithromycin for an additional 3 days (2.5g total)
    • 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
  • Stage 2: 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

RNA-based testing detected 40% of overlooked infections5

M. gen infection contains a very low organism load compared to other infections.5 For this reason, the CDC recommends NAATs for detection of M. gen. 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.6
Sensitivity of detection in patients with known M. genitalium infections6,7:

%

Aptima® M. genitalium assay RNA-based test

%

Aptima® M. genitalium assay RNA-based test

%

DNA-based LDT test

%

DNA-based test
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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. Martin D. Mycoplasma genitalium infection in men and women. UpToDate. Last updated October 31, 2019. Accessed August 20, 2020. https://www.uptodate.com/contents/mycoplasma-genitalium-infection-in-men-and-women. 4. Kent HL. Epidemiology of vaginitis. 5. 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. 6. 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. 7. 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.