Diagnostic Tests

What Physicians Need to Know

Aptima Assay for Detection of Mycoplasma genitalium Infection

 

Am Fam Physician. 2021 Nov ;104(5):517-518.

Author disclosure: No relevant financial affiliations.

The Aptima Mycoplasma genitalium assay is a nucleic acid amplification test (NAAT) for the detection of ribosomal RNA from M. genitalium. It is used to detect this common bacterial cause of sexually transmitted infections (STIs) in men and women using first-void urine or vaginal, endocervical, penile-meatal, or urethral swabs.1 The assay was approved by the U.S. Food and Drug Administration in 2019 and is the only NAAT approved for M. genitalium infection. M. genitalium is estimated to cause 15% to 25% of nongonococcal urethritis and is a common cause of recurrent urethritis in the United States.2

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TestIndicationPopulationCost*

Aptima Mycoplasma genitalium assay

Diagnosis of M. genitalium infection

Adolescents and adults (performance has not been evaluated in individuals younger than 15 years)

$35


*—Payment rate according to the Centers for Medicare and Medicaid Services clinical laboratory fee schedule. Accessed September 24, 2021. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files

TestIndicationPopulationCost*

Aptima Mycoplasma genitalium assay

Diagnosis of M. genitalium infection

Adolescents and adults (performance has not been evaluated in individuals younger than 15 years)

$35


*—Payment rate according to the Centers for Medicare and Medicaid Services clinical laboratory fee schedule. Accessed September 24, 2021. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files

Accuracy

A 2019 prospective study conducted at 21 sites in the United States compared the Aptima M. genitalium assay with a composite reference of three transcription-mediated NAATs targeting unique regions of M. genitalium 16S or 23S ribosomal RNA.3 Seven different specimen types were analyzed from 1,789 females and 1,604 males (self-collected first-catch urine, self-collected vaginal swab, clinician-collected vaginal swab, and clinician-collected endocervical swab for females; self-collected penile-meatal swab, clinician-collected urethral swab, and self-collected first-catch urine for males).

Overall prevalence of M. genitalium infection was 12.0% and 8.8% among symptomatic and asymptomatic participants, respectively. 3 The sensitivity of the assay was 90% or greater for clinician- and patient-collected vaginal and male urethral swab specimens and male urine specimens, 88.4% for penile-meatal specimens, 81.5% for endocervical specimens, and 77.8% for female urine specimens. Specificity was 97.8% or higher for all specimen types. Sensitivity and specificity were similar in asymptomatic and symptomatic participants.3 The Aptima M. genitalium assay package insert notes that for female patients, a vaginal swab is the preferred specimen type because of higher sensitivity; however, alternative

Address correspondence to Karl T. Clebak, MD, MHA, FAAFP, at kclebak@pennstatehealth.psu.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. U.S. Food and Drug Administration. FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. FDA news release. January 23, 2019. Accessed August 25, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-test-aid-diagnosis-sexually-transmitted-infection-known-mycoplasma...

2. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015 [published correction appears in MMWR Recomm Rep. 2015 64(33):924]. MMWR Recomm Rep. 2015;64(RR-03):1–137.

3. Gaydos CA, Manhart LE, Taylor SN, et al. Molecular testing for Mycoplasma genitalium in the United States: results from the AMES prospective multicenter clinical study. J Clin Microbiol. 2019;57(11):e01125–19.

4. Hologic. Aptima Mycoplasma genitalium assay [package insert]. Hologic; 2019. Accessed November 11, 2020. https://www.hologic.com/package-inserts/diagnostic-products/aptima-mycoplasma-genitalium-assay

5. Kirkconnell B, Weinbaum B, Santos K, et al. Design and validation of transcription-mediated-amplification nucleic acid amplification tests for Mycoplasma genitalium. J Clin Microbiol. 2019;57(8):e00264–19.

6. Le Roy C, Pereyre S, Hénin N, 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. Larose-Pierre M, Carter C, Honeywell MS. Aptima Mycoplasma genitalium assay. US Pharm. 2019;44(4):31–34.

8. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1–187.

9. Centers for Medicare and Medicaid Services. Clinical laboratory fee schedule. Accessed September 24, 2021. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files

This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

 

 

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