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HelpTest Code LAB9773 Mycoplasma genitalium
Additional Codes
M gen
Collection:
Urethral and Endocervical: Aptima (Gen-Probe) Unisex transport kit: Collect specimen with the blue swab and discard the white cleaning swab. Place the blue swab in the tube. Store and transport tubes either refrigerated or at room temp up to one week. Multitest swab specimen collection kit: Collect specimen with swab then place in thetube. Store and transport tubes either refrigerated or at room temp up to one week.
Urine: The patient should not urinate for at least 1 hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimen. Collect first catch urine in sterile container and transfer to Aptima (Gen-Probe) Urine transport tube within 24 hrs. Fill transport tube with urine so volume falls between the two black lines in the window of the tube. Store and transport tubes either refrigerated or at room temp up to one week. Urine specimens from females are acceptable, but not FDA-approved.
UNACCEPTABLE/REJECTED SPECIMENS:
No Swab in tube
White swab in tube
Culturette
Clean catch urines or any sources other than listed above
Overfilled or Underfilled Urine collection tube
Storage Instructions:
Send specimen to Lab within one week, room temp or refrigerated.
Turnaround Time (TAT)
Results are reported on the day test is performed.
Send to:
UMC Main Laboratory Specimen Receiving - EH319 Hospital Extension
Reference interval:
Negative
Performed in
UMC - Molecular Pathology
Request form
Routine Laboratory Request Form
Interpretive Data:
This assay is intended for use in the aid of diagnosis of Mycoplasma genitalium urogenital infections in male and female patients. The assay utilizes target capture and transcription-mediated amplification for the in vitro qualitative detection of ribosomal RNA (rRNA) from M. genitalium (Mgen).
This assay has been FDA-cleared for the following specimens: clinician-collected vaginal swabs, clinician collected endocervical swabs, female and male urine, clinician-collected male urethral swabs. Self-collected vaginal swabs, penile meatal swabs, and female and male urine are also acceptable specimens. For females, the vaginal swab is the preferred specimen.
Therapeutic failure or success cannot be determined with this test since nucleic acid may persist following appropriate antimicrobial therapy. A negative result does not preclude a possible infection. Negative results can be due to improper specimen collection, technical error, specimen mix-up, or target level below the assay limit of detection. Results should also be interpreted in conjunction with other clinical and laboratory data available to the clinician.
Test Availability:
Specimens are batch processed and tested once a week. Observed holidays may adjust testing schedule.