Aptima® Mycoplasma genitalium Test

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

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 Pelvic Inflammatory Disease (PID).1 Both women and men with M. gen infections can be asymptomatic and when left untreated, this infection can result in serious health consequences.1

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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.1 An accurate diagnosis is critical to ensuring infections are treated successfully.
Recommended treatments from CDC STI Treatment Guidelines 2021 are organism-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

 

The content in this piece is for information purposes only and is not intended to be medical advice.

The Aptima® Mycoplasma genitalium assay, a Nucleic Acid Amplification Test (NAAT), has up to 100% sensitivity.12‡ The Aptima® assay targets rRNA and out-performed DNA tests.13-14*†

M. gen infection contains a very low organism load compared to other infections.15 Peer-reviewed article reported that the rRNA-based Aptima M. gen assay had higher clinical sensitivity compared to that of DNA-based assay.13-14 The CDC recommends NAATs for detection of M. gen.1
Sensitivity of Detection in Patients with M. gen Infections:12-14

%

Aptima® M. genitalium assay RNA-based test

%

Aptima® M. genitalium assay RNA-based test

%

DNA-based LDT test

%

DNA-based test
*Sensitivity from peer-reviewed article Le Roy et al. study
†Sensitivity from peer-reviewed Unemo et al. study
‡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.
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