Mycoplasma genitalium, Transcription-Mediated Amplification, Post-Prostatic Massage Fluid/Urine or Peritoneal Fluids
Use
The test is used for detecting Mycoplasma genitalium, an under-recognized sexually transmitted infection (STI) that can cause acute and chronic non-gonococcal urethritis, cervicitis, and pelvic inflammatory disease. The Centers for Disease Control and Prevention (CDC) has recognized M. genitalium as an emerging public health threat due to its growing prevalence. It is often misdiagnosed as other STIs like Chlamydia trachomatis or gonorrhea, which can lead to improper treatment.
Special Instructions
The specimen source is required for this test. This test is not intended for use in medico-legal applications.
Limitations
Care must be taken to avoid cross-contamination during specimen handling. This test does not detect other Mycoplasma or Ureaplasma species. Appropriate specimen collection and handling are necessary for optimal assay performance. A negative test result does not exclude the possibility of infection due to improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low organism numbers. In low prevalence populations, false-positive results may occur more frequently than true positives. The test should not be used to assess therapeutic success or failure as nucleic acids may persist after therapy.
New York Approved
Methodology
Other
Biomarkers
LOINC Codes
- 100706-1
- 100706-1
- 31208-2
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
15 to 20 mL
Minimum Volume
Not provided
Container
Aptima Urine Specimen Transport Tube
Collection Instructions
1. Patient should not have urinated for at least 1 hour prior to collection. 2. Void small urine amount prior to prostatic massage and discard. 3. Perform prostatic massage by professional, then collect post-massage urine. 4. Transfer 2 mL to transport tube within 24 hours. 5. Ensure fluid level is between black fill lines on transport tube. 6. Store at 2 to 30°C within 30 days, refrigerate preferred. Do not freeze.
Storage Instructions
Store at 2 to 30°C, refrigerate preferred. Transport within 30 days.
Causes for Rejection
Overfilled or underfilled urine transport tubes, Specimen collected into SurePath Prep or ThinPrep, Midstream/clean catch urine, Tubes with swabs, Multiple sources on single tube
Stability Requirements
| Temperature | Period |
|---|---|
| Frozen | Specimen cannot be sent frozen. |