Aptima® Mycoplasma genitalium Test

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

Testing for M.gen in symptomatic patients is the current recommendation.1 However, both women and men with M.gen infections are often asymptomatic.2 Left untreated, this infection can result in serious health consequences.1

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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) cases1,2
  • Untreated PID can lead to adverse pregnancy outcomes1,2
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Men

  • More likely to exhibit symptoms of M. genitalium infection2
  • Responsible for 30% 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 and accurate diagnosis is critical to ensure infections are treated successfully.

Treatment is organism specific1
Trichomoniasis
  • Metronidazole
    2 g orally single dose or 500 mg orally 2x / day for 7 days
  • or
  • Tinidazole
    2 g orally single dose
Gonorrhea
  • Ceftriaxone
    IM 250 mg
  • and
  • Azithromycin
    1 g orally single dose
Chlamydia
  • Azithromycin
    1 g orally single dose
  • or
  • Doxycycline
    100 mg orally 2x / day for 7 days
Treatment considerations5
M. GEN
  • Some studies show that 1.5 g azithromycin over 5 days is preferred over single 1 g dose for treating M. gen
  • Azithromycin 1 g may result in the development of antimicrobial resistance in M.gen

RNA-based testing detected 40% of overlooked infections6

The M.gen infection contains a very low organism load compared to other infections.1 For this reason, the CDC recommends NAATs for detection of M.gen. Our RNA-based NAAT is far more sensitive that DNA-based tests—it accurately identified 40% of patients with M.gen infections missed by DNA-based testing.6

Sensitivity of detection in patients with known M. genitalium infections7:

%

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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