Mycoplasma genitalium, NAAT
Test Mnemonic
MYGAMP
CPT Codes
- 87563 - QTY (1)
LOINC ®
88226-6 urine; 69935-5 non urine
Aliases
- M genitalium
- M. gen
- M. genitalium
- Mgen
- MYGPCR
Includes
- Mycoplasma genitalium Result
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
In Vitro Diagnostic
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| One | Urethral | APTIMA Collection Unisex swab | Ambient | Ambient | Male Urethral Unisex (white tube blue swab): The patient should not have urinated for at least 1 hr prior to sample collection. Insert the blue swab 2-4 cm into the urethra. Gently rotate the swab clockwise for 2-3 seconds in the urethra. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| One | Endocervical | APTIMA Collection Unisex swab | Ambient | Ambient | Endocervical Unisex (white tube blue swab): Remove excess mucus from cervical os and surrounding mucosa using the white cleaning swab, then DISCARD. Insert blue swab into the endocervical canal and gently rotate clockwise for 10-30 seconds. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| 2 mL | Urine, first-catch | APTIMA Urine specimen collection kit | Ambient | Ambient | For female patients, vaginal specimens are preferred due to superior test performance characteristics. The patient should not have urinated for at least 1 hour prior to specimen collection. The patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container. Transfer 2 mL of urine into the Aptima urine specimen transport tube using the disposable pipette provided within 24 hours of collection. Close the tube tightly. Work with one specimen at a time. The correct volume of urine has been added when the fluid level is between the black fill lines (window) on the urine transport tube. Do not overfill or underfill the APTIMA Urine transport tube. |
| One | Vaginal | Aptima Multitest Collection Kit | Ambient | Ambient | Vaginal Multitest (orange tube pink swab): A vaginal swab is the recommended specimen for female patients due to superior test performance characteristics. Carefully insert the swab into the vagina about 2 inches past the introitus and gently rotate the swab for 10-30 seconds. Make sure the swab touches the vaginal walls so that moisture is absorbed by the swab. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| One | Other | Aptima Multitest Collection Kit | Ambient | Ambient | Penile Meatal (orange tube pink swab): Roll the swab on the tip of the penis, outside the opening of the penis (hole through which urine is passed). It is not necessary to put the swab inside the opening of the penis. Make sure to roll the swab all the way around the opening of the penis to get the best sample. Ensure the swab does not touch any other area of the skin. Place swab into Aptima transport tube. Snap off swab at the score line, and close the tube tightly. |
| 2 mL | Urine, first-catch | Sterile container | Ambient | Ambient | For female patients, vaginal specimens are preferred due to superior test performance characteristics. The patient should not have urinated for at least 1 hour prior to specimen collection. The patient should collect first portion of random voided urine (first part of stream) into a sterile, plastic, preservative-free container. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 15⁰C to 30⁰C. Swab in Aptima transport media: 60 days; Urine in Aptima transport media: 30 days; Urine unprocessed: 24 hours |
| Refrigerated | 2⁰C to 8⁰C. Swab in Aptima transport media: 60 days; Urine in Aptima transport media: 30 days; Urine unprocessed: 24 hours |
| Frozen | -20⁰C to -70⁰C Swab in Aptima transport media: 4 months; Urine in Aptima transport media: 4 months; Urine unprocessed: unacceptable |
Days Performed
Mon - Sun
Turnaround Time
1 - 4 days
Methodology
| Name | Description |
|---|---|
| Transcription-Mediated Amplification |
Reference Range
| Mycoplasma genitalium | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Special Info
Microbiology Preanalytic Guidance: http://portals.ccf.org/plmi/Laboratory-Medicine/Microbiology-Specimen-Collection-Transport-Information. Up to two tests can be run on a single Aptima Multitest Swab specimen (ie. GCCT+MYGAMP) - if specimen sources have been correctly selected, the shared tests will print on the same label. Do not place more than one label on a single collection tube. Common reasons for specimen rejection: 1. Inappropriate collection device for source selected. 2. Transport tubes containing a cleaning swab or more than 1 swab. 3. Overfilled or underfilled urine transport tubes. 4. Collection device expired prior to specimen collection. Related alternative orders: 1. URMPCR: sendout PCR test for Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis, and Mycoplasma genitalium from urogenital sites. Not recommended due to inconsistent data and unclear role for urogenital Ureaplasma and M. hominis testing. The majority of Ureaplasma infections are not associated with overt urethritis or cervicitis symptoms. 2. MYPLAS: in-house culture for Ureaplasma urealyticum and Mycoplasma hominis from urogenital sites. Not recommended due to inconsistent data and unclear role for urogenital Ureaplasma and M. hominis testing. Will not recover M. genitalium. 3. All other available mycoplasma and ureaplasma orders are for testing from non-urogenital sites.
Clinical Info
Mycoplasma genitalium is a sexually-transmitted gram-negative bacterium that lives on and in the epithelial cells of the urinary and genital tracts. M. genitalium can cause acute and chronic nongonoccal urethritis (NGU), cervicitis, and pelvic inflammatory disease. In lower risk populations, M. genitalium prevalence of approximately 1-3% has been reported in both men and women. In higher risk populations, prevalence of 10- 41% in men and 7.3-14% in women has been reported. The prevalence of M. genitalium in higher risk populations often exceeds that of Neisseria gonorrhoeae and is similar to the prevalence of Chlamydia trachomatis. M. genitalium infections largely go unrecognized, and infected individuals are either asymptomatic or have symptoms similar to those associated with other bacterial infections of the urogenital tract. Because M. genitalium is fastidious and difficult to culture, nucleic acid amplification testing (NAAT) is the diagnostic test of choice. The CDC recommends male patients with recurrent NGU should be tested for M. genitalium using an FDA-cleared NAAT. Female patients with recurrent cervicitis should be tested for M. genitalium, and testing should be considered for those with pelvic inflammatory disease. Screening of asymptomatic M. genitalium infection or extragenital testing for M. genitalium is not recommended. The Aptima Mycoplasma genitalium assay is an FDA-approved in vitro NAAT that utilizes target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies to detect 16s rRNA of M. genitalium. It is intended for use as an aid in the diagnosis of M. genitalium urogenital infections from clinician-collected and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal swabs (in a clinical setting).
Clinical Limitation
1. The performance of the assay has not been evaluated in individuals <15 years of age. 2. Therapeutic failure or success cannot be determined with the assay since nucleic acid may persist following appropriate antimicrobial therapy. 3. A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD). 4. The effects of tampon use, douching, and specimen collection variables have not been evaluated for their impact on assay detection. 5. For females patients, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated. 5. Assay interference may occur at high concentrations of mucus in the specimen. Competitive interference may preclude detection of M. genitalium in low quantities if M. pneumoniae is present in high quantities.
Clinical Reference
Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. PMID: 34292926; PMCID: PMC8344968.