Genital Mycoplasma Profile, NAA, Swab
Use
Detect Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma spp
Special Instructions
The test requires the collection of an endocervical, vaginal, or male urethral swab using the Aptima® swab transport system. Proper collection technique is essential to ensure adequate sampling and accurate results.
Limitations
This test was developed by Labcorp, and its performance characteristics have been determined by the laboratory itself. It has not been cleared or approved by the Food and Drug Administration, which has deemed such clearance or approval as unnecessary. The test's efficacy is based on Labcorp's internal validation. Results may be affected by inadequate specimen collection, transport delays, or inappropriate transport conditions.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 91134-7
- 69935-5
- 68546-1
- 68547-9
- 11502-2
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
One Aptima® swab
Minimum Volume
Not provided
Container
Aptima® unisex or vaginal swab
Collection Instructions
Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Endocervical swab: Insert the specimen collection swab into the endocervical canal and gently rotate. Male urethral swab: Insert the swab into the urethra and rotate.
Patient Preparation
The patient should not have urinated for at least one hour prior to specimen collection (for male urethral swab).
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions, prolonged delay (usually >72 hours), specimen leaked, expired transport device, inappropriate source, fixative or additives, Aptima® urine transport, Aptima® swab transport >30 days, cleaning swab in transport, non−Gen-Probe® swab in transport, multiple swabs, bloody or mucoid specimens, bacterial swabs, specimen in ProbeTec™ transport or Q-swabs.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |