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Aptima Mycoplasma genitalium Assay

The Aptima® Mycoplasma genitalium assay on the fully automated Panther® system is the first and only CE marked, sample-to-result NAAT test for the detection of the sexually transmitted bacterium, Mycoplasma genitalium. This assay addresses a global need for an accurate test for this clinically relevant STI.

This assay is not available for sale in the U.S. Please contact your local sales representative for product availability.

About

The Aptima Mycoplasma genitalium assay is the only CE marked, sample-to-result NAAT test for the detection of Mycoplasma genitalium. The infection caused by M. genitalium is:

  • Prevalent in approximately 6% of men and women attending STD clinics1
  • Responsible for 30% of persistent or recurrent urethritis in men.2
  • Detected in 10-30% of women with clinical cervicitis.3
  • Identified in up to 22% of pelvic inflammatory disease (PID) cases.3

Accurate detection of M. genitalium previously proved difficult because this organism is very difficult to culture.1 Aptima is the first assay CE marked sample-to-result NAAT that is commercially available to detect M. genitalium RNA.

The Importance of Accurate M. genitalium Detection

M. genitalium is more prevalent than gonorrhea and as prevalent as chlamydia in high-risk populations.4 M. genitalium infection is often asymptomatic.When patients do experience symptoms, they are similar to those associated with other urogenital tract bacterial infections.Men may be more likely to exhibit symptoms of an M. genitalium infection, while the infection is commonly asymptomatic in women.3,7

The Dangers of Untreated M. genitalium Infection

Left untreated, M. genitalium can cause:

  • Urethritis in men and women8
  • Cervicitis in women8
  • Pelvic inflammatory disease (PID) in women, which can lead to infertility, chronic pelvic pain and life-threatening tubal pregnancy9
  • An increased risk of HIV acquisition and transmission2
Application

The Aptima Mycoplasma genitalium assay can detect the presence of an infection from a number of sample types from asymptomatic and symptomatic men and women, including:

  • Vaginal Swab
  • Multitest Swab (Vaginal/Penile Meatal swab)
  • Urine (men and women)
  • Unisex Swab (endocervical and male urethral swab)
  • ThinPrep® Pap Test Vial

Refer to the assay package insert for additional information.

The Panther system allows for testing with the Aptima Mycoplasma genitalium assay alone or from the same sample collected for the Aptima Combo 2® (for gonorrhea and chlamydia testing) and Aptima® Trichomonas vaginalis assays.  Now, a single patient sample can provide a more complete picture of an individual’s STI status and allow laboratorians to provide more clinically relevant STI testing.

Performance

All tables and data in this section can be found in the Aptima Mycoplasma genitalium assay package insert.

References

1. Anagrius C, et al. Mycoplasma genitalium: prevalence, clinical significance, and transmission. Sex Transm Infect. 2005;81:458-62. doi:10.1136/sti.2004.012062.

2. Taylor-Robinson D, etal. Mycoplasma genitalium: from Chrysalis to Multicolored Butterfly. Clin Microbiol Rev. 2011;24(3):498-514. doi:10.1128/CMR.00006-11.

3. Centers for Disease Control and Prevention. Sexually Transmitted Diseases and Treatment Guidelines: Mycoplasma genitalium. http://www.cdc.gov/std/tg2015/emerging.htm. Updated June 4, 2015. Accessed Nov. 1, 2015.

4. Aptima Mycoplasma genitalium assay [package insert]. AW-14170-001. Marlborough, MA: Hologic, Inc.; 2015.

5. Haggerty C, et al. Mycoplasma genitalium: An Emerging Cause of Pelvic Inflammatory Disease. Infect Dis Obstet Gynecol. 2011;2011:959816. doi:10.1155/2011/959816.

6. Falk L, et al. Signs and symptoms of urethritis and cervicitis among women with or without Mycoplsama genitalium or Chlamydia trachomatis infection. Sex Transm Infect. 2005;81(1):73-8. doi:10.1136/sti.2004.010439.

7. Jensen J, et al. Management of Mycoplasma genitalium infections – can we hit a moving target? BMC Infect Dis. 2015;15:343. doi:10.1186/s12879-015-1041-6.

8. McGowin CL, et al. Mycoplasma genitalium: An Emerging Cause of Sexually Transmitted Disease in Women. PLOS Pathog. 2011;7(5):e1001324. doi:10.1371/journal.ppat.1001324.

9. CDC. Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseriagonorrhoeae – 2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm. Published March 14, 2014. Accessed Nov. 1, 2015.